Detailed Design Specification for the NASU...

Detailed Design Specification for the NASU Chemical InventorySystem (CISPRO)Point-of-Care Bedside Bar Code Verification

SystemDocument ID: document.doc

PharmaSys Hospital SolutionsCary, North Carolina

eMEDS PoC Bedside Barcode Verification SystemDate: 15-Feb-07

Prepared by:

PharmaSys Hospital Solutions

This document is the property ofPharmaSys Hospital Solutions

Detailed Design Specifications for the eMEDS Point-of-Care Bedside Bar Code Verification System

15-Feb-076

APPROVALSAuthor:

Signature: ______________________________________ Date: ________Signature by the Author, for all computer system engineering activities, indicates agreement and commitment to quality actions which assure:1. The correctness, accuracy, reliability, and completeness of the data contained within this document.Developer/Installer:

Signature: ______________________________________ Date: ________Signature by the primary Merck personnel responsible, for all computer system engineering activities, indicates agreement and commitment to quality actions which assure:

1. The correctness, accuracy, reliability, and robustness of the system.2. Formal methodologies and written technical standards, guidelines & procedures for development and

maintenance of the system are established.3. Documentation for the development, testing and maintenance of the system.

System Owner:

Signature: ______________________________________ Date: ________Signature by the primary Merck personnel responsible, for operations using system, indicates agreement and commitment to quality elements which affect the correctness and accuracy of the business area requirements of the system as it relates to the total operating environment.System Administrator:

Signature: ______________________________________ Date: ________Signature by the System Administrator, for all computer system administration activities, indicates agreement and commitment to quality actions which assure:1. The maintainability and the required functionality of the system.Quality Assurance:

Signature: ______________________________________ Date: ________

Computer Validation:

Signature: ______________________________________ Date: ________Signature by the primary Merck personnel responsible, for system quality issues and validation, indicate agreement and commitment to quality elements which affect the development and maintenance of the system as guided by approved methodologies and established technical standards guidelines and procedures.See also SOP 480-163 Review and Approval Responsibilities of Computer Validation Documentation

document.doc 2 of 64


15-Feb-076

PUBLICATION RECORD

Revision Description Author Date

0.1 Initial Draft, Not routed for review

Project20Percent Design Team 03-Jan-06



15-Feb-076

TABLE OF CONTENTS1. OVERVIEW.......................................................................................................................................... 6

1.1 PURPOSE OF SYSTEM...................................................................................................................... 61.2 ACRONYMS..................................................................................................................................... 61.3 SYSTEM ARCHITECTURE.................................................................................................................. 61.4 SUBSYSTEM DEFINITIONS................................................................................................................. 71.5 DATA DEFINITIONS.......................................................................................................................... 71.6 OPERATING SCENARIO.................................................................................................................... 81.7 BACKUP AND RECOVERY.................................................................................................................. 91.8 CRITICAL DESIGN CONSIDERATIONS...................................................................................................91.9 ASSUMPTIONS............................................................................................................................... 10

2. HARDWARE...................................................................................................................................... 102.1 HARDWARE RESOURCE ANALYSIS..................................................................................................102.2 HARDWARE DESCRIPTION AND TARGET CONFIGURATION..................................................................10

2.2.1 Data Server............................................................................Error! Bookmark not defined.2.2.2 Workstations........................................................................................................................ 11

3. GENERAL SOFTWARE.................................................................................................................... 113.1 OPERATIONAL SYSTEM SOFTWARE ENVIRONMENT..........................................................................11

3.1.1 Database Server.................................................................................................................. 113.1.2 Application Server................................................................................................................113.1.3 Workstations........................................................................................................................ 11

3.2 APPLICATION ENABLERS................................................................................................................113.2.1 Database.............................................................................................................................. 113.2.2 CISPRO............................................................................................................................... 11

3.3 LIBRARIES..................................................................................................................................... 113.4 PROGRAMMING ENVIRONMENT.......................................................................................................113.5 SECURITY..................................................................................................................................... 11

3.5.1 Login.................................................................................................................................... 113.5.2 Password............................................................................................................................. 113.5.3 Container Level Security......................................................................................................113.5.4 Field Level Security..............................................................................................................113.5.5 Security levels......................................................................................................................113.5.6 Auditing................................................................................................................................ 113.5.7 Expired usage...................................................................................................................... 113.5.8 Data integrity........................................................................................................................ 11

3.6 21 CFR PART 11 REQUIREMENTS.................................................................................................113.6.1 Electronic Signature.............................................................................................................113.6.2 Electronic Records...............................................................................................................11

4. SUBSYSTEMS DESIGN.................................................................................................................... 114.1 INPUTS AND OUTPUTS...................................................................................................................11

4.1.1 User Input Information..........................................................................................................114.1.2 Reports................................................................................................................................. 11

5. DATA................................................................................................................................................. 115.1 DATA DICTIONARY.........................................................................................................................115.2 DATA ARCHIVING........................................................................................................................... 11

6. LIMITATIONS AND EXPANDABILITY..............................................................................................116.1 SYSTEM LIMITATIONS.....................................................................................................................11



15-Feb-076

6.2 MASS MEMORY SPACE..................................................................................................................116.3 SYSTEM EXPANDABILITY................................................................................................................11

7. DOCUMENTATION............................................................................................................................ 117.1 REFERENCES AND STANDARDS......................................................................................................11

7.1.1 Internal Merck & Co., Inc. SOPs and Guidelines..................................................................117.1.2 External / Vendor Supplied Documentation..........................................................................11

7.2 MODIFICATIONS TO THE DETAIL DESIGN SPECIFICATION..................................................................11

APPENDIX 1 – DATA DEFINITIONS........................................................................................................11LISTING FOR 1_CISUSER.SQL....................................................................ERROR! BOOKMARK NOT DEFINED.LISTING FOR 2_CISUSER_SP.SQL..............................................................ERROR! BOOKMARK NOT DEFINED.LISTING FOR 3_CISADMIN.SQL...................................................................ERROR! BOOKMARK NOT DEFINED.

APPENDIX 2 – EMEDS DEPLOYMENT PROTOCOL..............................................................................11

APPENDIX 3 - NETWORK DIAGRAM......................................................................................................11



15-Feb-076

1. OVERVIEW

1.1 PURPOSE OF THE EMEDS SYSTEMAbout 1.5 billion dollars is lost every year due to improper administration of medications. Our system, eMEDS scans the bar codes of the patient, drug, and nurse in order to correctly match the three to known doctor's orders. This will significantly reduce the number of errors in hospital drug administration, resulting in fewer adverse reactions and loss of life.

1.2 ACRONYMSThe acronyms listed below are for use in COMPANY documents:

P/N Part NumberMSDS Manufacturers Safety Data SheetCFR Code of Federal RegulationsFDA Food and Drug AdministrationJCAHO Joint Commission on Accreditation of Healthcare OrganizationsGUI Graphical User InterfaceFRS Functional Requirements SpecificationID Identification / IdentifierLAN Local Area NetworkPC Personal ComputerQA Quality AssuranceQS Quality SystemSOP Standard Operating Procedure

1.3 SYSTEM ARCHITECTURE

The centerpiece of eMEDS is the barcode scanner. It scans three different barcodes that link to patient records, nurse information, and drug databases through a wireless network.

See Figure 1 for the eMEDS system architecture diagram.



15-Feb-076

Figure 1: eMEDS System Architecture

1.4 SUBSYSTEM DEFINITIONS

1.5 DATA DEFINITIONS

Data retained by the eMEDS system includes the following:

Medication InformationInventory ID NumberIdentity Dosage

Nurse Information Patient Information

ID NumberNameMedications prescribed



15-Feb-076

1.6 OPERATING SCENARIO

The eMEDS Point-of-Care Bedside Barcode Verification System reads previously encoded information regarding the nurse, patient, and drug and then ensures that the correct transaction occurs at the correct time.

The inputs are 3 barcode scans: patient, drug, and nurse. Also, the time and dosage are recorded. The doctor's orders are considered a previous input to the system for cross-checking.

A "proceed" or "halt" instructs the nurse to either administer the drug or not. This determination is based on the cross-checking of the inputs.

The eMEDS barcode Verification System will be utilized to:

scan nurse wrist band, patient wrist band, and single-dose medication prior to administration

interface with ADT systems to autofill the following patient information fields: medication date/time dosing size and units administering nurse's name room # dose # of total doses to be administered (e.g. dose 4 of 15)

interface with the following hospital systems: finance/cost accounting drug inventory laboratory information personnel system pharmacy information electronic prescription system

clearly alert nurse visually and aurally when there is a medication/patient mismatch send an automatic alert to defined recipients at the time of a medication/patient

mismatch (e.g. email, pagers, cell text messages) track the following medication/patient mismatch data:

administering nurse patient date/time of mismatch medication thwarted for delivery room #

reconcile the amount of medication administered vs. amount prescribed in real time make comments on the patient's medical record generate labels and wristbands containing barcodes and the following information:

patient ID patient name patient telephone admittance date

view information within the other hospitals systems without need for launching other applications

send relevant data to PharmaSys



15-Feb-076

The typical operating scenario involves a patient being admitted into a hospital and having a doctor check him out. The physician prescribes certain medications and enters them into the patient's record.

Later on, when the medications are to be administered, the nurse must scan his/her badge, the barcode on the drug, and the patient's barcode. The information from these three barcode scans is cross-checked against the doctor's orders. If everything matches up, the scanner displays a "proceed" order. If there is a mismatch at any point, the scanner displays a "do not proceed" order. All directives are documented for future reference.

1.7 BACKUP AND RECOVERY

The verification system will have the ability to produce hard copies of patient information, nurse and drug history, and doctor orders. Because the system pulls information from existing databases, it will not be considered liable for the loss of information in any certain database. If, for instance, the personnel file for a certain nurse is lost in the database, blame will not fall on the verification system. The hospital itself is responsible for backing up important patient, nurse and drug information.

The only data that will be created from the eMEDS system are the following:1. Comments on patient records2. Accountability record

a. Nurse administration history (successes/failures)b. Medication frequency (prescriptions per day/week/etc.)

The nurse administration history would be used to track nurses who fail to perform up to standard, i.e. those that frequently make bedside mistakes. Data collection in this area would be entirely voluntary. Optimally, the nurse administration history would be appended to the existing personnel database. Again, the verification system would not be held responsible for the loss of this data once it is registered in the personnel database. The medication information is slated to be sent to Company Name Here in Cary, North Carolina for purposes of record-keeping only. This information would be of interest in drug studies pertaining to the decline or increase in a drug's use. Again, the hospital would have to agree to this before collection began.

1.8 CRITICAL DESIGN CONSIDERATIONS

PDAHours of continuous operationWLAN (wireless local area network)Size of DisplayWater proof / Environmental sealingVolume (Length x Width x Height)WeightBest drop specificationsMicroprocessor speedMemoryUSB port includedSpeakers (present on model)



15-Feb-076

Cost

The program must provide information in a form that is easy to view and legible to the caregiver.

1.9 ASSUMPTIONS

It will be assumed that the hospital is WIFI-enabled.

Also, we are assuming that all nurse badges contain an identifying barcode and that the medications are packaged/barcoded in unit-doses. The 12-digit bar code number is assumed to encode for the drug's identity, strength, and _______. (ask Alex)

2. HARDWARE

2.1 HARDWARE RESOURCE ANALYSISThe eMEDS barcode verification system utilizes a two tier client/server architecture whereby data is stored on separate database servers and the application is stored on a handheld PDA equipped with a barcode scanner. The first tier consists of multiple databases within the hospital, including (but not limited to) patient records, accounting, personnel, laboratory results, and pharmacy information. The second tier, the PDA, uses its own processor and memory to perform the data gathering and cross checks.

2.2 HARDWARE DESCRIPTION AND TARGET CONFIGURATION

2.2.1 Barcode Scanner

The eMEDS system is configured for use of portable terminals/barcode scanners. The two portable terminal/barcode scanner types are:

Symbol MC70 Symbol MC50 Intermec CN3

2.2.1.1 Symbol MC70

Symbol MC70Assumed/RequiredMulticolor display Transflective color 3.5” QVGA with backlight,

TFT-LCD, 65K colors, 240 W x 320 L (QVGA size)Alpha keypad 26 Numeric key; 44 QWERTY key1-D scanner SE800HP 1D Linear ScannerWindows OS Microsoft® Windows™ Mobile 5.0 Premium, & Phone EditionSufficient memory 64MB RAM/128MB ROM MORE ROM



15-Feb-076

Sufficiently fast processor Intel® XScale™ 624 Mhz processor FASTERWLAN capabilities Tri-mode IEEE® 802.11a/b/gSpeaker(s) YesUSB port RS-232, USB 1.1Defining OptionsPhysicalDimensions 6 in. L x 3 in. W x 1.5 in H

15.3 cm L x 7.6 cm W x 3.7 cm HWeight LAN/PAN configurations - 11.2 oz./314 g

WAN/LAN/PAN configurations - 12 oz./336 gDisplay Size 3.5"Touchscreen Glass analog resistive touchBatteryMain Battery Lithium Ion 3.7V, 1900 mAh Smart BatteryStandard Capacity Battery Lithium Ion 3.7V, 1900 mAh Smart BatteryExtended Capacity Battery Optional 3.7V, 3800 mAh Smart BatteryBackup Battery Ni-MH battery (rechargeable) 1.2V, 2 cells (not user-accesible)SystemCPU Intel® XScale™ 624 Mhz processorOperating System Microsoft® Windows™ Mobile 5.0 Premium, & Phone EditionMemory 64MB RAM/128MB ROMUser EnvironmentHumidity 95% non-condensingDrop Specifications 4 ft. drop to concrete, 6 drops per 6 sides over operating

temperature range; 5 ft. drop to concrete, 2 drops per 6 sides at ambient temperature 73° F/23° C

Tumble Specifications 1,000 1.6 ft./.5 m tumbles (2,000 drops)WLAN OptionsData Rates Supported 1, 2, 5.5, 6, 9, 11, 12, 18, 24, 36, 48 and 54 MbpsOperating Channels Chan 8-169 (5040 – 5845 MHz)

Chan 1-13 (2412-2472 MHz)Actual operating frequencies depend on regulatoryrules and certification agency

Security WEP (40 or 128 bit), TKIP, TLS, TTLS (MS-CHAP), TTLS (MS-CHAP v2), TTLS (CHAP), TTLS-MD5, TTLS-PAP, PEAP-TLS, PEAP (MS-CHAP v2), AES, LEAP

2-D scanner2D Imager SE440 2D Imager EngineNon-Defining OptionsPhysicalExpansion Slot User accessible SDIO slot (with secure cover);Vibrate Mode NoAudio Speaker, receiver, microphone, headset jack,Headphone Jack software support for full duplex record and playback (stereo)MicrophoneSystemMemory Extension NoSpeech Recognition Software No



15-Feb-076

GPS NoUser EnvironmentOperating Temperature 14°F to 122° F/-10°C to 50° CStorage Temperature -40° F to 140° F/-40° C to 60° CElectrostatic Dischrage (ESD) +/-15kV air discharge, +/-8kV direct dischargeNetwork Connections Hardwire port NoWWAN eGPRS/GSM (850, 900, 1800 and 1900 MHz)WPAN Bluetooth Class II, v1.2WLAN OptionsSpreading Technique Direct Sequence Spread Spectrum (DSSS)

and Orthogonal Frequency Division Multiplexing (OFDM)Antenna Internal for LAN, External for WANVoice Communication (VoIP) Integrated Voice-over-IP ready (P2P, PBX, PTT), Wi-Fi™-certified,

IEEE 802.11a/b/g direct sequence wireless LAN2-D scanner optionsField of View Horizontal - 32.2°, Vertical - 24.5°Optical Resolution (gray scale) 640 H x 480 V pixels (gray scale)Roll 360°Pitch Angle +/- 60° from normalSkew Tolerance +/- 50° from normalFocal Dist. from Front of Engine Near: 5 inches, Far: 9 inchesAiming Element (VLD) 650 nm +/- 5 nmIllumination Element (LED) 635 nm +/- 20 nmAmbient Light Total darkness to 9,000 ft. candles (96,900Lux)Shock 2,000 +/- 5% GMinimum Print Contrast Minimum 25% absolute dark/light reflectance measured at 650 nm1-D scannerOptical Resolution 0.005 in. minimum element widthView Angle ?Pitch Angle +/- 65° from normalRoll +/- 30° from verticalSkew Tolerance +/- 60° from normalAmbient Light Sunlight: 8,000 ft. candles (86,112Lux)Artificial Light 450 ft. candles (4,844Lux)Shock 2,000 +/- 5% GScan Rate 50 (+/-6) scans/sec (bidirectional)Scan Angle 46.5° (typical)Depth of Field ?Laser Power 1.0 mW nominalPeripherals and AccessoriesBattery Chargers 4-slot battery charger (1X and 2X), universal battery charger

(requires adapters for 1X and 2X capacity batteries)Comm. and Charging Cables Serial and USB v1.1 charging cables, printer cables, vehicle

charging cable, power/charging cableCradels Single-slot serial/USB with spare battery charging for standard

and extended batteries, four-slot Ethernet cradle, vehicle



15-Feb-076

cradlePrinters NoneVertical-specific attachments Snap-on magnetic stripe reader, snap-on trigger handle, rigid caseRegulatoryElectrical Safety to UL / cUL 60950-1, IEC / EN60950-1EMI/RFI North America: FCC Part 15Hazardous Locations ?Laser Safety IEC Class2/FDA Class II in accordance with IEC60825-1/EN60825-1Quad Band eGPRS / GSM Global: 3GPP TS 51.010, GCF approved module

USA: FCC Part 22 , Part 24WLAN and Bluetooth USA: FCC Part 15.247, 15.407

Figure 2: Symbol MC70

2.2.1.2 Symbol MC50

Symbol MC50Assumed/RequiredMulticolor display Transflective color TFT-LCD, 65K colors,

240 (W) x 320 (L) (QVGA size)Alpha keypad QWERTY: 37-key1-D scanner CSE600 CMOS ImagerWindows OS Microsoft® Windows Mobile™ 2003 Second EditionSufficient memory 64MB RAM/ 64MB ROM



15-Feb-076

Sufficiently fast processor Intel® XScale™ 520 Mhz processorWLAN capabilities IEEE® 802.11bSpeaker(s) YesUSB port RS-232, USB 1.1Defining OptionsPhysicalDimensions 1D: 5.35 in. H x 2.95 in. W x .94 in. L

2D Imager: 5.35 in. H x 2.95 in. W x 1.13 in. LWeight QWERTY 1D: 6.77 oz/ 192 gDisplay Size 3.5"Touchscreen Glass analog resistive touchBatteryMain Battery Rechargeable Lithium Ion 3.7V, 1560 mAhStandard Capacity Battery Rechargeable Lithium Ion 3.7V, 1560 mAhExtended Capacity Battery Optional 3.7V, 3600 mAhBackup Battery Ni-MH battery (rechargeable) 15mAh 1.2V, 1 cellBattery LifeSystemCPU Intel® XScale™ 520 Mhz processorOperating System Microsoft® Windows Mobile™ 2003 Second EditionMemory 64MB RAM/ 64MB ROMUser EnvironmentHumidity 95% non-condensingDrop Specifications 3' drop to tile over concrete, 1 drop per side at 21° C ( 70° F)Tumble Specifications None givenWLAN OptionsData Rates Supported 1/2/5.5/11 MbpsSecurity WEP, TKIP, LEAP, PEAP, EAP-TLS, WPA (pre-shared key)2-D scanner2D Imager SE440 2D Imager Engine1-D scannerSupported Symbologies UPC /EAN, Code 39, I 2 of 5, Discrete 2 of 5, Code 128,

UCC.EAN128, Code 93, CodabarNon-Defining OptionsPhysicalExpansion Slot User accessible SDIO slot (with secure cover)Vibrate Mode NoAudioHeadphone Jack Speaker, receiver, microphone, headset jackMicrophone Software support for full duplex record and playback (stereo)SystemMemory Extension NoSpeech Recognition Software NoGPS NoUser EnvironmentOperating Temperature 0° to 50° C (32° to 155° F)Storage Temperature -25° to 60° C (-13° to 140° F)Electrostatic Dischrage (ESD) +/-8kV air discharge, +/-8kV direct discharge



15-Feb-076

Network Connections Hardwire port NoWWAN NoWPAN NoWLAN OptionsSpreading Technique Direct sequenceAntenna InternalVoice Communication (VoIP) Integrated Voice-over-IP ready (P2P, PBX, PTT)

Wi-Fi™-certified, IEEE 802.11b direct sequence wireless LAN2-D scanner optionsField of View Horizontal: 32.2°, Vertical: 24.5°Optical Resolution (gray scale) 640 (H) x 480 (V) pixelsRoll 360°Pitch Angle +/- 60° from normalSkew Tolerance +/- 50° from normalFocal Dist. from Front of Engine Near: 5 inches, Far: 9 inchesAiming Element (VLD) 650 nm +/- 5 nmIllumination Element (LED) 635 nm +/- 20 nmAmbient Light Total darkness to 9,000 ft. candles (96,900Lux)Shock 2,000 +/- 5% G1-D scannerOptical Resolution 0.005 in. minimum element widthPitch Angle +/- 65° from normalRoll +/- 30° from verticalSkew Tolerance +/- 60° from normalAmbient Light Sunlight: 8,000 ft. candles (86,112Lux)Artificial Light 450 ft. candles (4,844Lux)Shock 2,000 +/- 5% GScan Rate 50 (+/-6) scans/sec (bidirectional)Scan Angle 46.5° (typical)Laser Power 1.0 mW nominalCamera & Camera Options Available (choose 1D, 2D, OR Camera)Peripherals and AccessoriesBattery Chargers 4-slot battery charger (1X and 2X), universal battery charger

(requires adapters for 1X and 2X capacity batteries)Comm. and Charging Cables USB v1.1, vehicle charging cable, power/charging cableCradles Single-slot serial/USB with spare battery charging for standard

& extended batteries, 4-slot Ethernet cradle, vehicle cradle

Printers NoVertical-specific attachments Snap-on magnetic stripe reader, universal

cable cup adapter attachable cablesRegulatoryElectrical Safety UL60950, CSA C22.2 No. 60950, EN60950/IEC 950EMI/RFI YesHazardous Locations ?Laser Safety IEC Class2/FDA Class II in acc. w/ IEC60825-1/EN60825-1



15-Feb-076

Figure 3: Symbol MC50

2.2.1.3 Intermec CN3

Intermec CN3Assumed/RequiredMulticolor display 3.5 in (89 mm) QVGA (240 x 320 pixel)

64K color Transflective TFT-LCD, LED backlightAlpha keypad QWERTY or Numeric backlit keypad1-D scanner Integrated area imager: supports omnidirectional 1D, 2D,

& composite decode capabilitiesWindows OS Windows Mobile 5.0®Sufficient memory 128MB and Flash ROM 128MBSufficiently fast processor Intel® XScale PXA270, 520 MHzWLAN capabilities (802.11 & Bluetooth® standard) 802.11b/g (pending) Bluetooth Class 2,

V2.0, GSM/GPRS/EDGE, CDMA/1XRTT/EV-DO, GPS: Network-ind. embedded receiver

Speaker(s) Dual SpeakersUSB port USB 1.1 Host and ClientDefining OptionsPhysicalDimensions Dimensions with Standard Battery Pack: 6.3 x 3.2 x 1.1 in



15-Feb-076

Dimensions with Extended Battery Pack: 6.3 x 3.2 x 1.3 inWeight 397-454 g (14.0 oz - 16.0 oz)Display Size 3.5 in (89 mm) QVGA (240 x 320 pixel)Touchscreen NoBatteryMain Battery Lithium-Ion 3.7V, 2200 mAhStandard Capacity Battery 3.7V, 2200 mAh, (8.1 Watt-hour) Li-IonExtended Capacity Battery 3.7V, 4000 mAh, (14.8 Watt-hour) Li-IonBackup Battery N/ABattery Life 8.1 or 14.8 Watt-hoursSystemCPU Intel® XScale PXA270, 520 MHzOperating System Windows Mobile 5.0®Memory 128MB and Flash ROM 128MBUser EnvironmentHumidity 95% relative humidityDrop Specifications 26x all faces, sides from 1.2 m (4 ft)WLAN Options (802.11 & Bluetooth® standard) 802.11b/g (pending) Bluetooth Class 2,

SecurityWPA, 802.11i (WPA2), WEP, TKIP, TLS, TTLS, AES, PEAP, LEAP, MD5

2-D scanner2D Imager Integrated area imagerNon-Defining OptionsPhysicalExpansion Slot NoVibrate Mode NoAudioHeadphone Jack Wireless Bluetooth headset supportMicrophone YesSystem

Memory ExtensionCustomer-accessible miniSD slot for removable memory cards up to 2GB.

Speech Recognition Software YesGPS Yes: Network independent embedded receiver with integrated antennaUser EnvironmentOperating Temperature -10°C to +50°C (+14°F to +122°F)Storage Temperature -20°C to +70°C (-4° F to +158°F)Electrostatic Dischrage (ESD) +/- 15 kVdc air discharge, +/- 8 kVdc contact dischargeNetwork Connections Hardwire port NoWWAN V2.0, GSM/GPRS/EDGE, CDMA/1XRTT/EV-DO,

GPS: Network-ind. embedded receiverWPAN (802.11 & Bluetooth® standard) 802.11b/g (pending) Bluetooth Class 2,Voice Communication (VoIP) YesCamera & Camera Options 1.3 megapixel color camera with LED flashPeripherals and AccessoriesBattery Chargers YesCradels Yes



15-Feb-076

Figure 4: Intermec CN3

2.2.2 Servers

The eMEDS system is configured to communicate with multiple servers. The three main ones are the personnel database, the hospital's pharmacy database, and the patient database. Additionally, the eMEDS system will be able to communicate with the server containing the doctor's orders. All servers will be housed by the hospital and will be already in place once the verification system is implemented.

2.2.2.1 Computers



15-Feb-076

Will desktop computers at nurse workstations be an integral part of this system?

2.2.2.3 Label Printers

The system will utilize Intermec barcode label printers.

Printer Specifications:

3. GENERAL SOFTWARE

The eMEDS software is an integral component of the verification system. At the heart of the software is a graphical user interface (GUI) that was created in Microsoft Form Creator (?).

3.1 OPERATIONAL SYSTEM SOFTWARE ENVIRONMENT

3.1.1 Database ServerThe database server utilizes the HP-UX operating system.

3.1.2 Application ServerThe NASU Chemical Inventory System (CISPRO) application server utilizes the Windows NT 4.x operating system.

3.1.3 WorkstationsThe NASU Chemical Inventory System (CISPRO) workstations utilize Windows NT 4.x operating systems with Service Pack 6a.

3.2 APPLICATION ENABLERS

3.2.1 Database The NASU Chemical Inventory System (CISPRO) shall utilize Oracle 8.7.1 as installed on server WLNASU01. Tables are installed by running scripts included in Appendix 1 – Data Definitions and installed per Appendix 2 – Deployment Protocol.

3.2.2 CISPRO



15-Feb-076

The NASU Chemical Inventory System (CISPRO) utilizes CISPRO 2000 for Oracle, Version 4.13.19, an off-the-shelf software package as the major application.

3.3 LIBRARIES

As an Off-the-Shelf application, the NASU Chemical Inventory System (CISPRO) source code and/or libraries are not needed or available.

3.4 PROGRAMMING ENVIRONMENT

The NASU Chemical Inventory System (CISPRO) is a commercially available system developed by ChemSW, Inc. Development of this application was conducted in a controlled, development environment. No customization of the system is necessary. It is installed in the production environment and qualified prior to use.

3.5 SECURITY

3.5.1 LoginA user’s network login provides the initial security level for the CISPRO system, as they will need to have an active user ID and submit a valid network password to gain access to any computer system. Password entry will be in an encrypted format so that it is not visible to users or the System Administrator. Once users are successfully logged onto the network, only those users who have entered their active user ID and password for the CISPRO system are allowed access.

3.5.2 PasswordA minimum password length of eight characters is assigned by the CISPRO system administrator, and passwords can be changed by each individual user at-will or when their current password expires. The System Administrator can also de-activate a user account, or modify user privileges when necessary. Unauthorized access is prohibited.

3.5.3 Container Level SecurityThe Client/Server (C/S) version of CISPRO has an advanced security feature called "user container security". Basically this feature prevents users from modifying containers for which they do not have responsibility. One can enable this feature by going into File | Configure | Customize tab, and checking the "User Container Security" option.

With this option enabled, the logon user can only modify, delete or change quantity on containers that are assigned their user name in the Responsible field



15-Feb-076

of the container. Note that there are two additional access level permissions so that you can create "higher" levels of access.

For example, you might have a "GroupManager" access level, who should be able to manage containers for anyone in their department. In that case you can check the "Allow access to all users in department" permission in the Access Level dialog. There is also an "Allow access to all departments" permission which would allow access to any container (typically for administrators).

In order to use this feature effectively, you will need to perform some initial setup. All of the following steps work together to make sure User Container Security works in a logical fashion.

Steps to configure User Container Security

1) Create a list of Departments, using View | Departments

2) Create a list of Locations (use View | Locations) and assign each Location to a department

3) Create a set of Access Levels (use Levels... button from the User Accounts dialog) with proper permissions for various types of users

4) Create a list of User Accounts (use File | Configure and the Setup... button), and be sure to assign an AccessLevel and a Department to each user.

5) Add containers for each user, setting the Responsible field to the correct user name (logon) for the allowed user of that container.

Once this is done, one can enable User Container Security in File | Configure | Customize tab, and also Enable Security in File | Configure | Defaults tab.

From this point on, users can only access containers for which they are authorized.

3.5.4 Field Level SecurityClient/Server versions of CISPRO 2000 provide field level access control for all fields in the MAIN and BATCH tables. Note that in some cases you may configure access control such that it interferes with other features of CISPRO 2000. You are encouraged to seek technical support assistance when configuring this feature.

Basically, field level access means that for any field in MAIN or BATCH, you can specify whether a particular Access Level has read-only or read/write access to that field. An example will probably help here. Consider the following scenario. You would like to change the UserCheck1 check box field on the Identity tab so it is labeled "TSCA Chemical". This will be used as a flag for various reports, so most users should not be allowed to change it.

What we can do is define a new Access Level named "DefaultFieldAccess" that has this field set to read only. Then, whenever a user logs on without explicit read/write permission to this field, it will be marked read-only for them.



15-Feb-076

3.5.5 Security levelsAdministrator, Update, Limited Update, and Inquiry security levels are provided, and may be modified only by the system administrator. While the system administrator will have full access to the system, ordinary users have access to the following:

Change quantity of, add, modify, delete, dispose, and define Containers.

Add, delete, modify, and define Properties. View and modify Ingredients. Add, delete, and modify Main Records.

In addition, the system administrator can modify the system configuration, while users may only view the current configuration.

3.5.6 AuditingThe CISPRO system provides a means of comprehensive auditing operator usage that is not capable of being altered or deleted. The audit trail operates in the background, and does not require any user input. Audit trail data includes operator name, and server date/time information for all operations that cannot be altered. All logins, successful or not, are monitored by the CISPRO audit trail. Realtime login events are viewable.

3.5.7 Expired usageInactive users or staff of the CISPRO system may only be marked “inactive”, and cannot be entirely deleted from the system, though they may be reactivated at a later date only by a system administrator and only when a new password has been assigned.

3.5.8 Data integrityUsers are not permitted to alter or in any way change system commands or the software code. Only the system administrator is allowed to review and modify user privileges and access profiles.

3.6 21 CFR PART 11 REQUIREMENTS

The CISPRO system meets 21 CFR Part 11 requirements for a “closed” system. In addition, the system is capable of: discerning invalid or altered records; storing records for future review and retrieval; providing a clear and secure audit trail; verifying authorized users during login; assigning various incremental security levels for all users.

3.6.1 Electronic SignatureFor 21 CFR Part 11 compliancy, CISPRO 2000 has an available optional version called eSig (Electronic Signature). The eSig version provides advanced security features, and a secure, date-time stamped audit trail.

3.6.1.1 Security Manager (DIDMGR) Program

When using the eSig version of CISPRO 2000, several of the security data fields are stored in a separate schema. These items are:



15-Feb-076

user names passwords account expirations account enables user identity information Digital IDs

The schema which contains these additional fields should be tightly controlled by the system administrator.

The following security restrictions apply under eSig:

1) All security account information is controlled by the DIDMGR program, not from CISPRO 2000. Access to this program will be tightly controlled.

2) The user must have a database logon that allows access to the DIDADMIN schema.

3) All user names and digital ID’s are permanent: they can not be deleted or changed, you can only add new users and digital ID’s.

4) Passwords are stored securely, encrypted, and can only be replaced, not reviewed.

Note: The non-repudiation strength of the eSig feature relies on the security of the database server where CISPRO security information is stored. The tightest possible control should be maintained on authorized access to the DIDADMIN schema.

3.6.1.1.1 Logging into the DIDMGR

1) Start the DIDMGR program and enter the correct BDE alias information for the database server

2) Enter a valid DIDADMIN schema login

3) Click OK

3.6.1.1.2 Creating New Accounts

In order to use the eSig version of CISPRO, each user name security account in CISPRO must be exactly matched to a user name account in DIDMGR.

1) In DIDMGR, select Edit | New User

2) enter a unique user name and the password (twice).



15-Feb-076

Note: passwords must be mixed letters and numbers without repeating character sequences.

3) Click OK

4) modify the password expiration, and account enable as needed.

5) click the Digital ID button

6) Click Create New

7) Click Generate Random button

8) Click OK, then OK again to Close.

9) 10) Repeat from step 1 for each user.

Note, accounts can not be deleted. To reassign a lost password, select Edit | Change Password

3.6.1.1.3 Changing Digital ID

New Digital ID’s can be assigned periodically as needed. Old Digital ID’s must be obsoleted with an explanation as to why this was done. They are never deleted from the user account.

1) Select user account

2) Click Digital ID button

3) Click Obsolete

4) enter an explanation and click OK

5) click Create New

6) Click Generate Random

7) Click OK

8) Click Close

3.6.1.1.4 Security Traps

ESig is designed to prevent unauthorized access to CISPRO. This is done in several ways:

1) All login/log out events are logged. Use View | Monitor Login Events to review the log.



15-Feb-076

2) Incorrect passwords entered for valid user name are captured to the Log.

3) Incorrect passwords entered for valid user names 3 times in a row will disable the account.

4) All accounts have an expiration, after which the account is automatically disabled.

When accounts are disabled, the system administrator must use the DIDMGR program to fix the problem: either changing the expiration date on the account, setting the Failed Attempts back to zero, or simply re-enabling the account.

3.6.2 Electronic Records

The eSig feature produces audit trail data for all data tables in the system, which can be modified by a user. There are three methods for reporting on the audit trail:

1) Use an adhoc report design which accesses the AUDIT_tablename in question.

2) Use the Analyze Audit Trail History window to query the Audit tables

3) Use the Audi Trail Wizard

3.6.2.1 Adhoc Audit Trail Reports

DIDMGR ships with a set of example audit trail report designs, which can be used as the basis for new reports. Basically, an audit table is added to the report, fields are selected, filters are specified for the correct data of interest, and if desired, a page layout is created.

One important special feature is the ability to do real-time data verification. Every record in the audit trail is stamped with the database server date/time, user name, digital ID, and all fields values. This data has been cryptographically hashed, such that it would be impossible to alter any field value in the audit trail record and have the hash verify. The DIDMGR program knows how to verify this hash against the current audit trail record field values. In this way it is possible to verify that the record has not been altered after it was inserted into the audit trail.

All that is required to add verification to a report is to add a custom field named "Verify_Data". This report field will display as either "YES" (the record verified OK) or "NO" (the record has been altered). This is demonstrated in the Audit_Main.srw report provided with DIDMGR.

Refer to the section on Report Design for more information on building adhoc reports.



15-Feb-076

3.6.2.2 Analyze Audit Trail History

Another reporting feature is the ability to view the Audit Trial using the Analyze Audit Trial History window.

Creating a query is as simple as selecting the Audit Table and Key Field from the drop down lists, entering the Match To value and clicking the Search button.

3.6.2.3 Audit Trail Wizard

To provide users with an easier audit trail reporting system, CISPRO also includes an Audit Trail Wizard. The Wizard simplifies the process of generating verification of certain audit trail data. The user is lead through steps for selecting what data, what date period, and how to filter the data. There are three possible views, all are text output.

3.6.2.3.1 Timestamp listing (compact)This listing will simply show a list of records in the specified period. Only the audit info (audit record ID, date/time, operation, user name, digital ID, verification result) will be displayed.

3.6.2.3.2 Full record listing (verbose)All field values will be listed for each record in the selected data set.

3.6.2.3.3 Field Changes (analysis)DIDMGR will compare each audit trail record with a matching key value (defined internally by CISPRO) for changes between records. This allows the user to review the sequence of changes that occurred throughout the lifetime of the dataset.

3.6.2.3.4 Perform Data VerificationAs with the Adhoc Reporting feature for audit trail review, checking this option will cause DIDMGR to verify the cryptographic hash of each record, verifying that the record has not been altered since it was inserted.

3.6.2.4 General Information On the eSig Feature: Changes to Database

The following additions are made to the CISPRO database to provide infrastructure for the eSig feature:



15-Feb-076

1) triggers on various tables on user schema

2) DIDMGR schema for audit trail storage and user security info

3) AUDEXT table added

4) Additional stored procedures in user schema

3.6.2.5 Changes to the CISPRO 2000 Application for eSig

1) Network polling is always OFF

2) Security is always ON

3) Auto-logout on Idle is always ON with minimum of 2 minutes

4) All batch processing operations (RIBM actions and Tools menu) require revalidation of user name and password prior to performing actions.

5) All data operations are captured to the audit trail along with the server datetime stamp, user name, digital ID, operation type, and encrypted record/audit stamp hash data.

4. SUBSYSTEMS DESIGN

4.1 INPUTS AND OUTPUTS

4.1.1 User Input InformationThe NASU Chemical Inventory System (CISPRO) is an off-the-shelf system. Inputs, processes and output definition is a tool for development of custom programmed software and in not necessary for the integration of off-the-shelf software. For clarification, Inputs and outputs follows:

Inputs:Location InformationVendor Information Material CharacteristicsMaterial Hazard DataBarcode Container InformationInventory information

Outputs:Location InformationVendor Information Material Characteristics



15-Feb-076

Material Hazard DataContainer Labels

4.1.2 Reports

In particular CISPRO screens or functions available to the user there are a variety of reports available. The style and context of these reports can be customized, else they default to the current standard configuration stored by the CISPRO system. Users can print reports for individual records, or expand and limit the size of reports based on user-defined criteria.

The following is an abbreviated list of standard reports included in the CISPRO system:

Standard reports include the following data, which are all searchable regardless of formatting or font:

4.1.2.1 ChemicalAmounts.srw Report

The ChemicalAmounts.srw report will produce a listing of each chemical and the amount at each location (all containers per location).



15-Feb-076

4.1.2.2 ChemicalAmountsByLocation.srw Report

The ChemicalAmountsByLocation.srw report will produce a listing of each location, and then each chemical at that location (and the amounts).

4.1.2.3 Maximum Exceeded and Reorder Needed Reports

These two reports use the Warning Limits settings found on the Physical tab. They both total amounts based on the Reportable Units settings for each chemical. The Above Maximum reports shows items which have a total amount greater than the Maximum Allowable Warning Limit level. The Reorder report shows items below Minimum Allowable level. This data can also be formatted for E-Mail and sent via the Email Notification system.



15-Feb-076

4.1.2.4 Expired Containers

This report generates a list of containers whose expiration date is prior to today (the date you run the report). Note that Expiration Dates are specified for each container, and are set when they are Added (from the Qty/Locations tab). This data can also be formatted for Email and sent via the Email Notification system.



15-Feb-076

4.1.2.5 Disposal ListThis report provides details on each disposed container for a specified date period.



15-Feb-076

4.1.2.6 Transaction and Usage ReportsProvide various ways of displaying transaction data (assuming you have been using transaction logging).



15-Feb-076

4.1.2.7 Customizing ReportsCISPRO 2000 contains integrated ad-hoc reporting with full user control. Database reporting is a complex subject and even the most intuitive reporting tool can lead the user astray if they are inexperienced. That is why CISPRO 2000 comes with the built-in reports described earlier. You can use them as a basis for creating your own reports.

4.1.2.8 Barcode LabelsCISPRO provides a number of custom barcode label options. For backwards compatibility, SRW custom label files are still supported, but they are no longer the recommended method. (SRW custom label files are labels that are created in the report engine of CISPRO 2000 which is optimized for 8.5x11 reports).



15-Feb-076

CISPRO Custom Label Design Files (LBL) can be used with any printer that has a valid Windows Printer Driver which supports graphics. For example, the Eltron TLP printers which can be purchased from ChemSW. These printers have a Windows Graphical Printer Driver and are compatible with LBL files.

CISPRO contains a Label Designer with WYSIWYG display of the label design. To access this designer:

1) Start CISPRO2) Select File | Configure3) Go to the Labels tab4) type a filename that ends in .LBL such as label1.LBL into the Custom

Default Label box5) Right-click the box and select Design

If your printer does not have a graphics capable printer driver, but it does support EPL or ZPL (the Eltron or Zebra macro language for printing labels) you may want to refer to the Using ZPL and/or EPL for label printing topic.

In addition to the default, it is possible to define other custom label formats, and switch between them during the CISPRO session. To add additional label files, the system administrator would edit the \cispro\data\cis3.ini file (global system settings for all workstations) as follows:

[Label Files]lines=2label_1=Big_Label.lbllabel_2=Small_Label.lbl

4.1.2.8.1 Barcode Symbologies



15-Feb-076

CISPRO uses Code 3 of 9 (Code39) barcode symbology as the default. This symbology supports letters, numbers, and some punctuation (hyphens, dots). The barcode width is directly proportional to the amount of text encoded. For this reason, an 8 character barcode will require almost 2 inches of width.

There are other Symbologies which CISPRO supports (EPL and ZPL support even more), but only one other is worth mentioning here. In cases where a very small label is required, it is possible to use Code 128 C symbology to produce an 8 digit barcode that is only 0.8 inches wide. However, this symbology only supports numbers. If you wish to use Code 128 C with CISPRO, you will need to configure CISPRO to generate numeric-only Unique Container ID’s (see the section on Unique Container ID Generation).

Also note that thermal label printers should always print their barcodes in the same direction as the print head - that is to say, perpendicular to the direction of travel out of the printer. The printer has much greater resolution across the thermal print head when printing in this direction, and this allows the barcode to print with sharper lines even at smaller sizes. It is possible to rotate barcodes in the designer, and you should also consider whether to use label stock that is rotated correctly for your purposes to start with.



15-Feb-076

4.1.2.8.2 Using ZPL and/or EPL for label printing

For printers that do not have a Windows Printer Driver, but do support Eltron Printer Language (EPL) or Zebra Printer Language (ZPL), you can use the Windows Generic Text Printer Driver to send these printer macro command files for printing custom label designs.

Designing these types of labels requires a knowledge of EPL or ZPL, or alternatively, you can use a label design program like BarTender from Seagull Scientific Software to print a design to a file.

Once you have the EPL or ZPL file, you can place CISPRO field tags into the file so that when label is printed, the correct container information is placed on the label.

Here is a list of possible fields:Field Tag Description{@caption} BATCH.UniqueContainerID{@title} MAIN.NameRaw{@trailer} SIZETYPE.Size_Description{@NameRaw} MAIN.NameRaw{@Comments} MAIN.Cmments{@ID2} MAIN.ID2{@ID3} MAIN.ID3{@Description} MAIN.Description{@HazardDescription} MAIN.HazardDescription{@Lot_Number} BATCH.Lot_Number{@Expiration} BATCH.Expiration (mm/dd/yyy

format){@Responsible} BATCH.Responsible{@Exp2} BATCH.Expiration (mon-yyyy format){@Size_Description} SIZETYPE.Size_Description{@Catalog_Number} SIZETYPE.Catalog_Number{@ExtraText} SIZETYPE.ExtratNumber (product id

code){@Location} LOCATES.Location{@username} Current login name

5. DATA

5.1 DATA DICTIONARY The scripts used to create the oracle database define the database. They consist of three scripts as follows:

1_cisuser.sql 2_cisuser_sp.sql 3_cisadmin.sql



15-Feb-076

They are included in Appendix 1 – Data Definitions.

5.2 DATA ARCHIVINGNecessities for data archiving were not included in the functional requirements specification for the system. The NASU Chemical Inventory System (CISPRO) Oracle database server as implemented at Merck is capable of storing over two million records. At a maximum rate of 500 records per day, it will take 16.7 years before data archival is needed. The actual anticipated data input rate will be much less that the maximum rate. Considering these figures, data archival is not a critical function of the system.

If data archival is necessary, the internal tape backup system installed on the server and backup utilities will be used. See 1.7 for details of the backup system.



15-Feb-076

6. LIMITATIONS AND EXPANDABILITY

6.1 SYSTEM LIMITATIONSThere are no limitations on the number of maximum users for the CISPRO system as a whole. However, concurrent usage allowed on the CISPRO system is currently set at 5, which is dependent upon the number of users allowed by the current license code distributed upon installation of the CISPRO system. Changes to the installed licensing information must be cleared with the software vendor.

6.2 MASS MEMORY SPACEA new CISPRO database is not limited in terms of size. However, a database of 1000 records will require approximately 3.5 MB of disk space. Additionally, the CISPRO database will grow or shrink in size to accommodate the number of records being actively stored. As currently installed the database consumes 2.6 GB of drive space, with 4.5 GB remaining.

6.3 SYSTEM EXPANDABILITYNew versions of CISPRO software may be made available at a future date. The decision to update to newer versions, or to install upgrades, will be subject to approval at that time. General maintenance of the CISPRO system is conducted by Merck staff and, when necessary, the vendor.



15-Feb-076

7. DOCUMENTATION

7.1 REFERENCES AND STANDARDS

7.1.1 Internal Merck & Co., Inc. SOPs and GuidelinesDocument Number Title SourceMerck Corporate Policy Number 28

Computer System Validation Merck Management Guide

POL 3.30 Automation Validation Policy MMD Quality Manual Policy

VGDL 3.30 CSV: System Life-Cycle Methodology

MMD RAS-Validation Guideline

VGDL 3.33 CSV: Requirements Specification


VGDL 3.32 CSV: Configuration Management MMD RAS-Validation Guideline

VGDL 3.34 Computer System Validation: Design Specification


SOP 451-104 MIS Computer Backup Storage Control

MMD - Wilson Standard Operating Procedure

Stability Lab-078-QAP.doc CISPRO System Quality Assurance Plan

Merck Management

7.1.2 External / Vendor Supplied DocumentationTitle Source LocationNASU Chemical Inventory System (CISPRO) Installation CD w/users manual

ChemSW MMD – Wilson NASU Retention Room A

Videx Laserlite Pro Operators Manual

Videx MMD – Wilson NASU Retention Room A

2722, 2742, 3742 Thermal Printer User Documentation & Software CDROM

Eltron MMD – Wilson NASU Retention Room A



15-Feb-076

7.2 MODIFICATIONS TO THE DETAIL DESIGN SPECIFICATION

The Detail Design Specification is the basis for qualification, validation and acceptance of the developed system. The developer is responsible for identification of any exceptions to the Detail Design Specification and initiation of a revision. During the course of a project, additional revisions to the Detail Design Specification are to be expected. Any member of the project team or the developer may initiate these revisions. In all cases, a formal procedure should be identified that provides for incorporation of the proposed revision including an appraisal of the impact of the proposed change on the project. The revised document should then be reviewed and approved prior to the initiation of further development.



15-Feb-076

APPENDIX 1 – DATA DEFINITIONS


Detailed Design Specification for the NASU Chemical Inventory System (CISPRO)

Appendix 2 – Deployment Protocol

2/15/2007

LOGO HERE

APPENDIX 2 – DEPLOYMENT PROTOCOL

Title: Deployment ProtocolPurpose: Describe requirements and procedure for deployment.

CONTENTS

1. REQUIREMENTS............................................................................................................................... 111.1 INSTALLATION TOOLS..................................................................................................................... 11

1.1.1 Software............................................................................................................................... 111.1.2 System Hardware and Software................................................................................................111.1.3 Hardware (optional)................................................................................................................... 111.1.4 Configuration Data.....................................................................................................................11

1.2 SERVER........................................................................................................................................ 111.2.1 Oracle Server....................................................................................................................... 111.2.2 File/Application Server.........................................................................................................11

1.3 CLIENTS........................................................................................................................................ 111.4 SITE SPECIFIC ISSUES...................................................................................................................11

2. ORACLE SERVER SETUP................................................................................................................112.1 LOGINS......................................................................................................................................... 112.2 SCRIPTS....................................................................................................................................... 11

3. FILE SERVER SETUP.......................................................................................................................113.1 BDE INSTALLATION.......................................................................................................................113.2 CISPRO INSTALLATION...................................................................................................................... 11

4. GENERAL CLIENT SETUP...............................................................................................................114.1 ORACLE (OCI) INSTALLATION.........................................................................................................114.2 CISPRO INSTALLATION.................................................................................................................11

4.2.1 BDE...................................................................................................................................... 114.2.2 CISPRO............................................................................................................................... 114.2.3 ChemACX............................................................................................................................ 114.2.4 eSig DIDMGR......................................................................................................................11

5. CISPRO APPLICATION SETUP........................................................................................................115.1 SERVER CONNECTION SETUP........................................................................................................115.2 SECURITY SETUP..........................................................................................................................11

eSig Security Setup............................................................................................................................ 115.2.2 Admin Account.....................................................................................................................115.2.3 User Accounts........................................................................................................................... 11

6. PRINTING SETUP............................................................................................................................. 116.1 REPORT PRINTER SETUP...............................................................................................................11




2/15/2007

LOGO HERE

6.2 LABEL PRINTER SETUP.................................................................................................................. 116.2.1.1 Shared Printer – Network Driver Installation........................................................................116.2.1.2 Local Printer – Local Driver installation................................................................................116.2.2 Configuring the installed printer drivers................................................................................116.2.3 Custom Label Layouts..........................................................................................................116.2.4 Label Form Factor..................................................................................................................... 11

7. RIBM SETUP..................................................................................................................................... 117.1 HARDWARE INSTALLATION..............................................................................................................11

7.1.1 Videx LaserLite Pro..............................................................................................................117.1.2 Symbol PDT6800.................................................................................................................11

7.2 RIBM SOFTWARE CONFIGURATION................................................................................................117.2.1 Generic Functions................................................................................................................117.2.2 Custom Functions................................................................................................................11

8. METTLER ELECTRONIC BALANCE CONFIGURATION.................................................................11

9. CISPRO CONFIGURATION...............................................................................................................11

ADDENDUM A.............................................................................................CHEMACX CONFIGURATION11

ADDENDUM B..........................................................................................................SITE LABEL LAYOUT11

Defaults.............................................................................................................................................. 11Label Files.......................................................................................................................................... 11Label Printer Info................................................................................................................................ 11Local ini settings................................................................................................................................. 11

ADDENDUM C.............................................................................................SITE RIBM CONFIGURATION11

Program Filename................................................................................................................................ 11Program Filename................................................................................................................................ 11Program Filename................................................................................................................................ 11Program Filename................................................................................................................................ 11Program Filename................................................................................................................................ 11Program Filename................................................................................................................................ 11

ADDENDUM D.........................................................................................SITE CISPRO CUSTOMIZATION11

ADDENDUM E....................................................................................DISTRIBUTION CD CONTENT LIST11




2/15/2007

LOGO HERE

1. REQUIREMENTS General requirements for performing all phases of CISPRO software installation.

1.1 INSTALLATION TOOLS

1.1.1 Software CISPRO CDROM Optional Catalog Database CDROMS (ChemACX, ECID, TSCA) SQL*Plus with OCI installed Net Service Name / alias defined for Oracle server Hyperterminal (for RIBM and balance testing) Seagull Printer Driver (for Eltron Printer) Windows OS CDROM (for generic text driver) Other Label Printer Driver disks1.1.2 System Hardware and Software Windows 9x,Me,NT4, 2000 workstations Oracle 7.3 or better

Note: if using Oracle 8i or higher, OCI client tools must match version. CISPRO will not work properly if the client is running v7.x tools and the server is Oracle 8i. This is a known bug in Oracle.

1.1.3 Hardware (optional) Eltron Printers with printer cables Videx LaserLite Pro with cradle and cable Symbol PDT6800 with cradle and cable Mettler Electronic Balances with proper serial cable

1.1.4 Configuration DataAddendum’s B through C of this protocol provide worksheets for both system global configuration (all stations), and local station configuration (one sheet per station affected). They should be completed with input from the customer and used to configure the software on-site.

1.2 SERVER

1.2.1 Oracle Server Net Service Name / TNS alias server alias must be identified and accessible from installation machine SPL*Plus access or equivalent script capability must be available DBA must create logins with known user names and passwords, which have RESOURCE and CONNECT

roles assigned. 10MB of table space is normally adequate for most CISPRO initial deployments, using auto-increment of

space in 10% blocks. More space may be needed if the number of chemicals times the number of containers exceeds 25,000.

1.2.2 File/Application ServerCISPRO requires approximately 15MB for the BDE shared DLL’s installation, and 10MB for the CISPRO installation. The application supports UNC pathing.




2/15/2007

LOGO HERE

1.3 CLIENTSCISPRO requires no client storage. It creates two local INI files named cis3.ini and grids.ini in the \windows or \winnt directory. If installing the ECID, TSCA, or ChemACX catalog options, additional hard disk space is required on the workstation. The space required varies: approx. 50MB TSCA, approx. 250MB ECID, approx. 800MB ChemACX.

If installing ChemACX, the workstation must have a current ODBC driver for Microsoft Access 97 or better.

1.4 SITE SPECIFIC ISSUES1.4.1 Two different deployments.The Merck NASU facility will use two different versions of CISPRO. One is eSig enabled (21 CFR Part 11 compliant audit trail features), the other is a standard CISPRO installation. Both versions will be hosted on Oracle. Each version will be connected to a different logical database. This means that 2 schemas will be needed for the regular CISPRO version, and 3 schemas will be needed for the eSig CISPRO version.

Additionally, for the regular CISPRO version, there will be two different types of handheld hardware configurations: Videx LLP, and Symbol PDT6800 (intrinsically safe areas only). This means there are effectively 3 different workstation configurations for handheld hardware (see RIBM Configuration Addendum).

Finally, this site uses a custom label design (merck.lbl, see Label Addendum). This label is system global across both version. It requires numeric only, 6 digit padded serial container ID numbers.

This site does not use special features of CISPRO such as Add On List catalogs, or electronic scale interfacing. No data importing will be done during deployment.




2/15/2007

LOGO HERE

2. ORACLE SERVER SETUP

2.1 LOGINSDefault logins/passwords from CISPRO scripts are:cisuser/userpwdcisadmin/masterkey.

Logins and passwords can be changed as needed, but the scripts will need to be “search & replaced” to accommodate the changes to schema names.Steps:1) create login cisuser with RESOURCE and CONNECT roles.2) create login cisadmin with RESOURCE and CONNECT roles.3) for eSig deployment, create an additional login didadmin with RESOURCE and CONNECT roles.4) if the logins are changed, search and replace the CISUSER, CISADMIN and DIDADMIN (eSig only) schema names

in all scripts.

2.2 SCRIPTSSteps:1) start SQL*Plus login as CISUSER and run the following scripts in order:

1_cisuser.sql2_cisuser_sp.sql

2) start SQL*Plus login as CISADMIN and run the following scripts in order:3_cisadmin.sql

3) for eSig deplyment, start SQL*Plus and login as didadmin, then run script:didmgr.sql

4) for eSig deployment, start SQL*Plus and login as cisuser, then run script:diduser.sql

Note: The eSig security model will prevent logging into CISPRO to create an admin account. This is most easily corrected by modifying the existing default admin account in the CISADMIN schema with the following SQL command:

Update CISADMIN.PWD2 set username=’some_expected_didmgr_acctname’ where username=’admin’;

3. FILE SERVER SETUP

3.1 BDE INSTALLATIONNote: S:\apps\chemsw\bde\ is the example file server installation path used in this document for the BDE. Please replace this path with the proper BDE path to your network file server.Steps:1) On the supplied CD, navigate to the BDE folder. Copy all of the files within the BDE folder to S:\apps\chemsw\bde

(replace with the correct path to your file server) Be sure to remove the read-only attribute from these files and folders after copying them from the CD.

2) Navigate to the new BDE folder on your file server and open the file default.ini in notepad. Verify the following values:

3) Search for this line: [Database Engine\Settings\DRIVERS\ORACLE\DB OPEN]4) Then verify that the lines within that section are as follows:

SERVER NAME={Oracle TNS alias here}NET PROTOCOL=TCP/IP

5) Save and exit the file.

Note: The TNS alias listed in step #4 above is the same alias used in section 4.1 (client OCI setup). This alias is defined by the Oracle DBA.




2/15/2007

LOGO HERE

3.2 CISPRO INSTALLATION

NON-ESIG Steps:1) Navigate to the 12411 folder on the CD. Copy all contents into the S:\apps\chemsw\cis installation folder.

ESIG Steps:1) Make a copy of the S:\apps\chemsw\cis folder for ESIG use, for example S:\apps\chemsw\cisESIG. Be sure to

also copy the entire contents.2) Navigate to the 12422 folder on the CD. Copy all contents into the new folder created in step 1 (S:\apps\

chemsw\cisESIG)3) From this folder new folder, remove the following file types:

ADV*.SBASIC*.S

4. GENERAL CLIENT SETUP

4.1 ORACLE (OCI) INSTALLATIONSteps:1) install Oracle client utilities (OCI) to the workstation2) Use Net8 Easy Config to create a Net Service / TNS alias to the Oracle server3) verify the connection is valid using SQL*Plus and the cisuser login as necessary.

4.2 CISPRO INSTALLATION

4.2.1 BDE

Steps:1) Run BDEINST.EXE in the BDE folder on the fileserver. Choose the third option, “Install BDE32 using

Specified Source Directory”, then click Browse, and navigate to the S:\apps\chemsw\bde. Click open, and then finish.

Note: The following steps only need to be performed on the FIRST workstation. If you have already performed these steps once, you do not need to do them again: move on to section 4.2.2.

2) Launch the BDEADMIN.EXE utility located in the S:\apps\chemsw\BDE folder. Go to the configuration tab, and drill down to Configuration | Drivers | Native | Oracle. For Oracle 8i, verify (and change if necessary) the following settings as follows:

DLL32: SQLORA8.DLLVENDOR INIT: OCI.DLLNET PROTOCOL: TCP/IPSERVER NAME: {Oracle TNS Alias here}

3) Press CTRL-A, respond OK to the prompt to save all edits, and then exit and re-start the BDEADMIN.EXE4) On the databases tab, right-click and select “New” to create a new database alias. Choose “Oracle” from

the drop down list. The alias name is now selected – change it to something meaningful, for example ChemSW_Oracle. Right-click, choose Apply. Verify that the settings for this new alias (especially the server name) are correct. If you must make any changes, do not forget to right-click again and choose Apply. During installation of other ChemSW Products, this alias name will be used, so please note it.

5) To test the new alias, you can either use the accounts created by the DBA for this software (reference the DBA installation sheet), or you can use a default Oracle logins, such as scott/tiger. You can also choose not to test the alias at this point. To test the new alias, right-click the alias and select Open. Enter the login/password you wish to test (either those assigned by the DBA or the scott/tiger login) and then click OK. A green box around the alias icon (after a short delay) indicates that the alias is functional.

Exit the BDEADMIN program. BDE configuration is complete.




2/15/2007

LOGO HERE

4.2.2 CISPRONote: CISPRO supports both UNC and logical drive mapping. The preferred method is logical drive mapping. Given that certain features of CISPRO use full pathing to external files (email notification reporting for example) it is a good idea to use common shared drive mappings across all workstations that will be using CISPRO.Steps:1) create a desktop shortcut to CIS32ORA.EXE located in the \CISPRO folder on the fileserver.2) make sure that the shortcut has the working directory (also known as the “Start In” directory) set to the

same folder where cis32ora.exe is running from.

4.2.3 ChemACXChemACX is an optional add-on catalog database available for CISPRO. The Catalog is provided as a structure database and an MDB file. For this reason, the workstation must have an ODBC driver for Microsoft Access (97 or better).

See ChemACX Configuration Addendum.

4.2.4 eSig DIDMGRFor eSig deployments, copy the DIDMGR.EXE & CRYPT01.DLL files to the fileserver. While this program may be copied to the same directory where cis32ora.exe (CISPRO main executable) is installed, it is important to maintain tight security on DIDMGR.EXE. For this reason, it is recommended that the program be placed in a separate directory from the rest of CISPRO, and directory permissions be configured so that only the System Administrator can run files in that directory.

Note the DIDMGR requires a valid BDE installation on the workstation from which it will be run, just like CISPRO.

Make sure you create a \data folder under the folder where DIDMGR is installed.Make sure you create a \reports folder under the folder where DIDMGR is installed and place the Audit_?*.srw sample reports there.

5. CISPRO APPLICATION SETUP Note: At this point, the protocol assumes that all previous steps have been completed. This means the Oracle schemas have been created, the OCI has been installed and configured for the correct TNS on the workstation, the BDE and CISPRO application have been delivered to the fileserver, the workstation has been configured for BDE use, and the workstation has a CISPRO shortcut.

5.1 SERVER CONNECTION SETUPSteps:1) Start CISPRO2) If the Server Access dialog does not display, select File | Configure… (if the Server Access Setup dialog does not

appear, click the Server Setup… button).3) Fill in the User tab as follows:

alias: ChemSW_Oracle (see section 4.2.1 Step #3)login: cisuser (see section 2.1 Step #1)password: userpwd (see section 2.1 Step #1)

4) Fill in the Admin tab as follows:alias: ChemSW_Oracle (see section 4.2.1 Step #3)login: cisadmin (see section 2.1 Step #2)password: masterkey (see section 2.1 Step #2)

5) Fill in the Concurrency tab as follows:alias: ChemSW_Oracle (see section 4.2.1 Step #3)login: cisuser (see section 2.1 Step #1)password: userpwd (see section 2.1 Step #1)

6) Click OK7) Exit CISPRO. The changes will take effect at the next startup of CISPRO.




2/15/2007

LOGO HERE

5.2 SECURITY SETUPMost CISPRO installations have security enabled. This provides access level roles for each user, limiting what they can do in the application. It is critical that an Admin account be created prior to enabling security so that the System Administrator does not become “locked out” of the application.

Note: For eSig deployments only, the DIDMGR.EXE program must be installed and security accounts configured prior to creating security accounts in CISPRO.

eSig Security SetupFor eSig deployments, every user must have a security account defined in the DIDMGR program. This account will have full user identity information, including identity verification data (e.g. Driver’s License number), and a unique Digital ID. Note that both User Names and Digital ID’s are UNIQUE, and can not be deleted. For this reason some pre-planning is needed to make sure that user names are sufficiently unique for all users. Passwords are encrypted in the database and can not be retrieved. Therefore, if a password is lost, the system administrator will need to assign a new password to the user.

Steps:1) Start DIDMGR.EXE2) Enter BDE alias (section 4.2.1 step #3) and didadmin login and password (section 2.1 step #3)3) Click OK to loginFor each user:4) Select Edit | New…5) Enter username and password (twice), then click OK6) Modify the account expiration as needed7) Check Account Enabled if this account should be active8) Fill in identity info with full user name and indentity document info9) Select Edit | Save Changes10) Click Digital ID button.11) Click Assign New… button12) Click Generate Random button13) Click OK and then Close14) Repeat from step #4 for each new user15) After exiting DIDMGR, copy [didmgr]\data\logon.ini to [cispro]\data folder.

5.2.2 Admin AccountNote: The eSig security model will prevent logging into CISPRO to create an admin account. This is most easily corrected by modifying the existing default admin account in the CISADMIN schema with the following SQL command:Update CISADMIN.PWD2 set username=’some_didmgr_name’ where username=’admin’;

Since the admin account is defined by default with Configuration access (System Modify privilege) when the database is created, this will allow you to enter CISPRO and begin configuring other accounts.

Steps:1) Start CISPRO2) Select File | Configure3) On the Defaults tab, click Security…4) Click the Levels… button.5) Click Add, enter “admin” into the Level Name box and then click Save6) Check the Modify Configuration (ADMIN) permission, then click Save again7) Click Close8) Click New9) Type in an admin account name, password, and set the Access Level to the admin level that was just

created.10) Click Save, then Close11) Click OK to close the Configuration dialog.12) Select File | Login and then use the new account to re-enter the system.

5.2.3 User AccountsNow that an admin account has been created, it is necessary to create other access level roles for users. Typically, the admin account (with Modify Configuration privilege) is reserved for only one system administrator. All other users have different access levels that does not have this privilege.




2/15/2007

LOGO HERE

Note that without the Modify Configuration privilege, the Configuration dialog will look dramatically different to the application user. All features which are global configuration for CISPRO will be inaccessible. Only local hardware configuration (printer selection, electronic balance interface, and RIBM hardware configuration) will be available.

For eSig versions, these usernames must exactly match usernames created in DIDMGR (section 5.2.1). Password assigned here are not used but must not be blank. Suggested dummy value is ”1”.

Steps: (to create a user account)1) Login as the admin2) Select File | Configure3) Click the Security… button4) Click Levels… button5) define a new level with appropriate permissions as necessary6) Close the Access Levels form7) Click New to create a new user, enter username and password (twice)8) assign the correct Access level from the list9) Click Save10) Repeat for each user. Multiple users can share the same Access Level (role).

6. PRINTING SETUP

6.1 REPORT PRINTER SETUPCISPRO report printers must be standard Windows printers defined on the workstation where CISPRO will be running. Network and/or local printers may be used. Any printer with a valid graphical Windows printer driver may be used, but page size printers are best suited to reports.Note that printer selection is a local workstation configuration parameter, which is stored in the [windows]\cis3.ini file. The printer name is persisted between CISPRO session, and will produce an error if CISPRO is started when the printer has been removed from the workstation’s printers folder.

Steps:1) Start CISPRO2) Select File | Configure3) Select the Labels tab4) Click Browse… next to the Report Printer section5) Select the printer for reports from the list, and set the orientation if necessary.6) Click OK7) Click OK to save the Configuration dialog info.

6.2 LABEL PRINTER SETUPCISPRO allows an alternate printer to be selected for label printing. This is normally done when a dedicated label printer is available (for example the Eltron Thermal Transfer printers sold by ChemSW, Inc.). Label form factors must be correctly configured for the printer driver before trying to print from CISPRO.

Note: Windows printer drivers vary substantially in how they are configured. This section applies specifically to the Seagull Eltron TLPxx42 driver series. Other drivers and other printers will require different configuration steps.

6.2.1.1 Shared Printer – Network Driver Installation

You need to know the network address of the printer. This is either a IP address such as 127.0.0.1 or a server path such as \\server4\eltron2742.

Steps:1) Logon to the server the printer will be shared from.2) Select Start | settings | Printers and then double-click Add Printer3) Select local printer, configure the port as necessary4) When prompted for driver selection, click “have disk” and select the Seagull driver folder5) Complete the printer installation, configure the security and share the printer.6) Logon to the workstation with Administrator privileges




2/15/2007

LOGO HERE

7) Select Start | Settings | Printers and then double-click Add Printer8) Select Local Printer (even though it is a network printer), and connect to a parallel port (use LPT2).9) Click Have Disk… and select the seagull driver folder.10) Select your model of printer and then click Finish to install the printer, do NOT print a test page.11) select the printer, right click and select Properties12) Go to the Ports tab. If the port you need is not listed, click Add Port13) Select Digital network Port or TCP port and then enter the printer path or IP.14) Click OK then check the correct port and click OK

6.2.1.2 Local Printer – Local Driver installation

Steps:1) Logon to the workstation with Administrator privileges2) Select Start | Settings | Printers and then double-click Add Printer3) Select Local Printer and select the appropriate port.4) Click Have Disk… and select the seagull driver folder.5) Select your model of printer and then click Finish to install the printer, do NOT print a test page.

6.2.2 Configuring the installed printer driversSteps:1) Highlight the printer and then select Document Defaults from the Printer folder’s File menu.2) Click Page Setup tab, then Edit…3) Adjust the form factor for the page size to match your label4) Click OK, then OK again.5) The printer is now configured for use.Note: If using ZPL or EPL label designs, the label printer will be connected through the Windows Generic Text Driver. This should be connected to the printer (local or network port) in the same manner as a normal graphical windows printer. Text printers do not need the Document Defaults setup.

6.2.3 Custom Label LayoutsCISPRO has a built-in label format which may not suit the deployment environment. It is possible to define custom label layouts and use them instead. Custom label designs are normally created by ChemSW and delivered to the customer as .LBL files. IN cases where a printer does not have a valid Windows Printer Driver, it is also possible to create printer “macro” labels for Zebra (ZPL) and Eltron (EPL) printers.Steps:1) Obtain the custom label files from ChemSW, place them in the same directory on the fileserver where the

cis32ora.exe file is located.2) Start CISPRO3) Select File | Configure4) Go to the Labels tab5) Check Use Custom Default Label File6) enter the path to the DEFAULT LBL, ZPL, or EPL file.7) Click OK8) For additional custom formats, add the following to the [fileserver]\cispro\data\cis3.ini. To add new labels to

the toolbar drop down menu for barcode printing:[Label Files]lines=2label_1=2nd_label_filenamelabel_2=3rd_label_filename

See Site Label Layout Addendum for further instruction.

6.2.4 Label Form FactorIf using .LBL labels, or the standard built-in format, (not required for SRW, EPL, or ZPL labels) the Label Form Factor must be specified:Steps:1) Start CISPRO2) Select File | Configure3) Select the Labels tab4) Click the Barcode ID Label Setup… button5) Adjust the settings as needed. For a label printer using 2 inch wide by 1 inch high labels on a roll:

Printer Type: Continuous RollLabels Per Page: 1Label Height: 2Label Width: 1




2/15/2007

LOGO HERE

Copies: 1Labels Across: 1Labels Down: 1X Origin: 0Y Origin: 0Horizontal Gap: 0Vertical Gap: 0

6) Click OK and then OK again.

7. RIBM SETUP

7.1 HARDWARE INSTALLATIONCable Note 1: The Videx LLP cradle comes with a proprietary RJ11-DB9F cable. This will connect to the typical Windows PC serial port connector which is a DB9M. If the workstation uses a DB25, an adapter may be needed. This should be obtained by the customer prior to ChemSW’s arrival.

Cable Note 2: The Symbol PDT6800 cradle uses a “null modem” DB25M-DB9F cable. This will connect to the typical Windows PC serial port connector which is a DB9M. If the workstation uses a DB25, an adapter may be needed. This should be obtained by the customer prior to ChemSW’s arrival. This cable can be ordered from Symbol or obtained from a computer supply store.

Both the Videx and Symbol handhelds use a serial port for communication with the host PC. It is critical that a computer technician verify the host PC for an available working COM port, prior to ChemSW’s arrival. ChemSW can not control hardware incompatibilities in a customer’s environment.

The recommended method for testing the hardware is to use Windows Hyperterminal to direct connect to the selected COM port at 9600 baud, 8 data bits, 1 stop bit, and No parity. A device such as a modem or other serial device can then be connected to the port and checked for comand echo to verify the port is available.

7.1.1 Videx LaserLite ProSteps:1) Insert good batteries into the Videx. Move the lock switch away from the locked position and press then

scan key. The display will come on if the device is powered properly.2) Connect the cradle to the PC COM port using the attached cable.3) Start CISPRO4) Select File|Configure, then the Advanced tab5) Click RIBM Setup…6) Select Videx Laserlite Pro and set the correct COM Port.7) Click OK and then OK again.

Testing:1) Wake up the Videx by pressing the scan button, then set it back in the cradle2) immediately click the drop down button next to the RIBM button on the toolbar and select Program

Collector.1) If the communications is successful, a message box will be displayed that the Videx is ready to go.2) Trouble: The most common problems are:1) Videx is not awake2) *.s program files are set read-only (must be read/write)3) COM Port is not available4) Cable is bad5) Cradle is bad

7.1.2 Symbol PDT6800Steps:1) Charge the PDT prior to use by setting it in the cradle and plugging the cradle into an A/C outlet. Press the

red PWR button to turn the unit on. The display will come on if the device is powered properly.2) Connect the cradle to the PC COM port using the attached cable.




2/15/2007

LOGO HERE

3) Start CISPRO4) Select File|Configure, then the Advanced tab5) Click RIBM Setup…6) Select Symbol PDT6800 and set the correct COM Port.7) Check the “Device sets mode” box and type MAINPROG.HEX into the box to the right.8) Click OK and then OK again.

Testing:1) click the drop down button next to the RIBM button on the toolbar and select Program Collector.2) Follow the on-screen instructions for programming the PDT.

1) Trouble: The most common problems are:1) COM Port is not available2) Cable is bad

7.2 RIBM SOFTWARE CONFIGURATION

7.2.1 Generic FunctionsSteps:1) Select File|Configure2) Select the Advanced Tab3) Click RIBM Setup… button4) Select the correct Operation mode, and other options5) Click OK, and then OK again.

7.2.2 Custom FunctionsSee Site RIBM Configuration Addendum for specifics.

8. METTLER ELECTRONIC BALANCE CONFIGURATION CISPRO Provides integrated electronic balance support for Mettler balances equipped with RS232 communications (such as models AB,PB,SB,B,PG-S). All balances require the correct interface cable. As with RIBM configuration, the System Administrator must verify that the workstation where the balance will be installed has an available COM port.

Steps:1) Connect the balance to the COM port using the correct cable, and power up the balance.2) Start CISPRO3) Select File | Configure4) Go to the Balance tab5) Check Enable RS-232 Balance Interface6) Select Mettler7) Set communications parameters as needed for the balance.8) Click OK,9) Exit and restart CISPRO

Testing:1) Start CISPRO2) Navigate to a chemical with a container (or create one)3) Click Change Qty button4) place some weight on the balance5) Click the left balance button in the Change Quantity dialog. If the communication is successful, the weight on the

scale will appear in the Amount box.

See Site CISPRO Customization Addendum for specifics

9. CISPRO CONFIGURATION See Site CISPRO Customization Addendum for specifics




2/15/2007

LOGO HERE

ADDENDUM A. CHEMACX CONFIGURATION

ChemACX is NOT being installed for Merck NASU.




2/15/2007

LOGO HERE

ADDENDUM B. SITE LABEL LAYOUT Merck deployment has only one label definition.

Label Description Filename Format (LBL,EPL,ZPL,SRW)Merck 0.75” x 2” label MERCK.LBL

See label layout reference below.

LBLNote:1) code 128 c format requires numeric only barcode format2) 0.75” high requires 6 digit container ID padding.

Global INI Settings:

Defaults[Defaults]UseCustomLabel=1CustomLabelFile=[path]\merck.lbl

Label Files[Label Files]lines=0label_1=merck.lbl

Label Form Factor Info[Bar Code Setup]Rolls=1Sheets=0PerPage=1Height=0.75Width=2.0Copies=1Across=1Down=1X_Origin=0Y_Origin=0H_Gap=0.0625V_Gap=0UseLowDensity=0

Label Printer InfoEltron TLP-2642,TLP-2742,TLP-3742Thermal Transfer on Polyester 0.75” wide, 2.0 inches long, rolled landscape (roll is 0.75” wide)Seagull Eltron Driver is set for Doc Defaults of: 0.75” wide x 2” high, landscape.

Local ini settings[Label Printer]




2/15/2007

LOGO HERE

PrnDevice=Eltron TLP3742 (EPL2)PrnDriver=winspoolPrnPort=\\win2k600\ELTRONLandscape=0Orient=0Height=508 //label height, in inches, multiplied by 254Width=191 //label width, in inches, multiplied by 254[Report Printer]PrnDevice=PrnDriver=winspoolPrnPort=Landscape=0

MERCK.LBL Definition (for reference only)[barcode]human_readable=1symbology=3orientation=1x=2y=0height=30enabled=1

[text]lines=9line_1=@NameRaw 1 20 7 Arialline_2=Lot: @Lot_Number 18 20 7 Arialline_3=Purity: @Description 33 20 7 Arialline_4=Expires: @Exp2 50 20 7 Arialline_5=@Comments 81 20 7 Arialline_6=Qty: @Amount 65 20 7 Arialline_7=line_8=line_9=

[label]height=1width=2.0x=0.00y=0.00border=0




2/15/2007

LOGO HERE

ADDENDUM C. SITE RIBM CONFIGURATION Merck has 3 possible workstation configurations, as listed below. Note that permission for the program should be set in the handheld program INI file.

Workstation Configuration 1 – eSig with Videx (Part 11)

Program Filename Einout.s

INI Filename Einout.iniMenu Title Check In/Out (Part 11)Device (LLP,PDT) LLPWorkstation IDCOM Port

Program Filename Einvent.s

INI Filename Einvent.iniMenu Title Inventory (Part 11)Device (LLP,PDT) LLPWorkstation IDCOM Port

Local INI Settings:(Use RIBM Setup Dialog for hardware config)

[RIBM MENU]dynamic=1enable_clear=0enable_file=0enable_program=1enable_download=1

[RIBM PROGRAMS]lines=2line_1=einout.iniline_2=einvent.ini

Notes: EINVENT.INI & EINOUT.INI should both be set to require MultiRecOps permissions.




2/15/2007

LOGO HERE

Workstation Configuration 1 – Videx (non Part 11)

Program Filename inout.s

INI Filename inout.iniMenu Title Check In/Out Device (LLP,PDT) LLPWorkstation IDCOM Port

Program Filename invent.s

INI Filename invent.iniMenu Title Inventory Device (LLP,PDT) LLPWorkstation IDCOM Port



[RIBM PROGRAMS]lines=2line_1=inout.iniline_2=invent.ini

Notes: INVENT.INI & INOUT.INI should both be set to require MultiRecOps permissions.




2/15/2007

LOGO HERE

Workstation Configuration 3 – PDT6800 (non Part 11)

Program Filename Pinout.s

INI Filename Pinout.iniMenu Title Check In/OutDevice (LLP,PDT) PDTWorkstation IDCOM Port

Program Filename Pinvent.s

INI Filename Pinvent.iniMenu Title InventoryDevice (LLP,PDT) PDTWorkstation IDCOM Port



[RIBM PROGRAMS]lines=2line_1=einout.iniline_2=einvent.ini

Notes: PINVENT.INI & PINOUT.INI should both be set to require MultiRecOps permissions.




2/15/2007

LOGO HERE

ADDENDUM D. SITE CISPRO CUSTOMIZATION

Global Settings (File | Configure)

Tab Item SettingDefaults Use Transaction Logging OffDefaults Autologin on startup OnDefaults Default Database Always OnDefaults Autologout after idle OnDefaults Autologout interval (minutes) 5Labels Use Default Custom Label OnLabels Default Label Filename Merck.LBLCustomize Force Automatic Container ID OnCustomize Require valid Vendor OffCustomize Require valid Catalog# OffCustomize Require valid Expiration OffCustomize Force new container quantity OffCustomize Container quantity value BlankCustomize Use Catalog# to validate new OffCustomize Require department for user acct OffCustomize Use default units OnCustomize Default units value MgCustomize User container security OffCustomize Received date required OffCustomize Auto-hazard text OffAdvanced Poll network OffAdvanced Poll network value 20Advanced Show startup errors OffAdvanced Use MSDS URL: OffAdvanced MSDS URL value BlankAdvanced Pass (MSDS search field) AnyAdvanced Multiple Languages OffAdvanced Simulate Locks OffAdvanced Struct DB (path) BlankEmail Notify Include Report Viewer download OffEmail Notify Report Viewer URL DefaultEmail Notify Include message DefaultEmail Notify Message text Default

Global Settings (\cispro\data\cis3.ini)

[Expressions]Expires_2=LT(TODAY+30 days)

[Defaults]barcode_numeric=1barcode_serial=1barcode_min_width=6




2/15/2007

LOGO HERE

Local Settings (File | Configure)

Tab Item SettingDefaults Preview Direct Reports OffDefaults Enable RIBM Support Some WorkstationsDefaults Enable Ordering Support OffDefaults Enable Chemoffice Support OffDefaults ChemACX Setup (path) Not-usedLabels Report Printer Depends on stationLabels Label Printer Eltron, depends on stationLabels Barcode ID Label Setup (size) See label addendumAdvanced Enable SAF Imports OffAdvanced SAF Target IgnoredAdvanced RIBM Setup (device) Depends on stationAdvanced RIBM Setup (COM port) Depends on stationEmail Notify Enable Email Notify OffBalance Enable RS232 OffBalance Type MettlerBalance COM IgnoredBalance Parity NBalance Timeout 250Balance Data Bits 8Balance Baud 9600Balance Stop Bits 1

Local Settings ([windows]\cis3.ini)See Label menu settings in Label AddendumSee RIBM menu settings in RIBM Addendum

Local Settings (Windows Defaults)Date setting should be mm/dd/yyyy or equivalent four digit year.




2/15/2007

LOGO HERE

ADDENDUM E. DISTRIBUTION CD CONTENT LIST Software contained on the deployment CD for Merck NASU:

Documentation\manual

\12220man_1.doc\cis32c.hlp\cis32c.cnt

\deployment\ Merck Implementation Specification.doc

\test_plans\12411\(*.xls and *.doc)

\12422\(*.xls and *.doc)

\DataFiles\*.* (All Data Files required to complete the test plans)

\didmgr\DidMgr-v105.xls

\DidMgrTestPlan.doc \handhelds

\cispro_pdt_inout.doc \cispro_pdt_inout_v101.xls

\cispro_pdt_invent.doc\cispro_pdt_invent_v101.xls\cispro_videx_einout.doc

\cispro_videx_einout_v101.xls\cispro_videx_einvent.doc

\cispro_videx_einvent_v101.xls \cispro_videx_inout.doc \cispro_videx_inout_v101.xls \cispro_videx_invent.doc

\cispro_videx_invent_v102.xls

CISPRO Application Files\12411\cis32ora.exe & *.* (cispro files)

CISPRO eSig Executable Replacement\12422\cis32ora.exe

DIDMGR Application\didmgr\didmgr.exe\didmgr\crypt01.dll\didmgr\reports\Audit_Main.srw\didmgr\reports\Audit_Batch.srw

BDE Support Files\10004\*.* (bde files)

Label Files\labels\merck.lbl

Handheld Support Files\Videx

pro122a.os




2/15/2007

LOGO HERE

vxcrf.dll\Symbol

sendhex.exesender.bat

Handheld Programs\handhelds

\inout.s\inout.ini\invent.s\invent.ini\pinout.hex\pinout.ini\pinvent.hex\pinvent.ini

(note: subdirectories below denote minutes idle timeout)\2

einout.seinout.inieinvent.seinvent.ini

\5einout.seinout.inieinvent.seinvent.ini





Appendix 3 – Network Diagram

2/15/2007

LOGO HERE

APPENDIX 3 - NETWORK DIAGRAM


Date post:	14-Apr-2020
Category:	Documents
Upload:	others
View:	6 times
Download:	0 times

Detailed Design Specification for the NASU...

Documents