Stand-alone CorneaTrax™ v1.0 ISBT 128 Labeling System...

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Stand-alone CorneaTrax™ v1.0

ISBT 128 Labeling System

Validation Plan

Facility Name ______________________________________________

ICCBBA Facility Identification Number (FIN) ______________________________

Facility Address ________________________________

________________________________ ________________________________

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Table of Contents Instructions for CorneaTrax Validation Plan .......................................................................................... 3

Validation Plan Approval ....................................................................................................................... 3

Introduction ........................................................................................................................................... 4

Purpose ................................................................................................................................................... 4

Validation Terminology .......................................................................................................................... 4

Roles and Responsibilities ...................................................................................................................... 5

Scope ...................................................................................................................................................... 6

Risk Assessment ..................................................................................................................................... 7

Requirements and Specifications ........................................................................................................... 7

User Requirements (UR) .................................................................................................................. 7

Design Specifications (DS) ................................................................................................................ 9

Software, Hardware, and Supplies ....................................................................................................... 10

Software ........................................................................................................................................ 10

Hardware ....................................................................................................................................... 10

Supplies .......................................................................................................................................... 11

Testing Qualification Overview ............................................................................................................ 11

Installation Qualification (IQ) ......................................................................................................... 12

Operational Qualification (OQ) ...................................................................................................... 12

Performance Qualification (PQ) ..................................................................................................... 12

Discrepancy Management ............................................................................................................. 12

Acceptance Criteria ........................................................................................................................ 13

Final Validation Summary ..................................................................................................................... 13

Final Validation Acceptance and Approval ........................................................................................... 14

References ............................................................................................................................................ 14

Attachment A: Testing Instructions ...................................................................................................... 15

Attachment B: Test Data Preparation Instructions .............................................................................. 17

Attachment C: Discrepancy Resolution Form and Instructions ........................................................... 18

Attachment D: Installation Qualification (IQ) ....................................................................................... 19

D.1. Software and Hardware Checklist .......................................................................................... 19

D.2 Software and Hardware Installation........................................................................................ 22

Attachment E: Operational Qualification (OQ) .................................................................................... 28

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E1. Configuration and DIN Set-Up.................................................................................................. 28

E2. Security Levels and Incomplete Field Warnings ...................................................................... 36

E3. Scan a DIN to Populate DIN Field ............................................................................................. 41

Attachment F: Performance Qualification (PQ) ................................................................................... 44

F.1. Label Creation ......................................................................................................................... 44

F.2. View; Export Print Logs; Edit and Reprint Label ...................................................................... 51

1. Instructions for Stand-alone CorneaTrax™ Validation Plan

Instructions about how to use this plan are shown in italics. These can be removed as the plan is updated by the facility. Read entire plan to prepare for validation including, but not limited to, identifying and securing resources and preparing test data. Some areas/tasks that will need to be customized for your facility include:

1) Identify staff to fulfill validation roles and responsibilities (including IT resources) 2) Define the scope of the validation 3) Update risk assessment as needed 4) Add design specifications as determined by scope 5) Prepare, review and approve test data 6) Expand IQ/OQ and PQ scripts as needed 7) Obtain approval of plan prior to plan execution.

2. Validation Plan Approval for Execution Enter approver name(s) and job title(s) with the appropriate authority to approve the plan. Approvers must sign and date in the spaces provided below. The following signatures indicate approval of Validation Plan prior to its execution.

Approver Name Job Title Signature Date

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3. Introduction ISBT 128 is the global information standard for the terminology, identification, coding and labeling of medical products of human origin (including blood, cells, tissues, and organs).

ISBT 128 is viewed as a critical tool to achieve standardization of product coding and labeling when shipping ocular tissue internationally. It has been designed and perfected to ensure the highest levels of accuracy, safety and efficiency for the benefit of donors, patients and health care professionals. ISBT 128 provides:

• Globally unique donation (product) identification, in accordance with regulatory requirements for traceability

• Internationally-accepted terminology, definitions, product codes, and reference tables • Support for the open movement of products around the world in such a way that critical

information is rapidly, accurately, and unambiguously communicated • International consistency to support the transfer, traceability and transfusion/transplantation of

blood, cells, tissues and organs.

4. Purpose The purpose of this Plan is to provide the required documentation, testing procedures and acceptance criteria which will demonstrate proper installation, operation, and performance of the Stand-alone CorneaTrax™ ISBT 128 Labeling System. The system includes software, printer, bar code scanner, and supplies. See Section 10 of this Plan for detailed description of system components.

5. Validation Terminology

Term Meaning Validation Plan (VP) Document that outlines goals, objectives, and acceptance criteria; defines and sets

scope for components that will be validated; as well as describes tasks, roles and responsibilities, and test methods.

User Requirements (UR) Describes what the equipment and software is intended to do and all essential requirements. The owner usually develops this document.

Design Specifications (DS)

Describes the detailed characteristics and layout of software and printed data fields on the label.

Installation Qualification (IQ)

Establishes documented evidence that hardware, software and other supplies are received as designed and specified, are properly installed and configured in the selected environment, and that the environment is suitable for its operation and use.

Operational Qualification (OQ)

Demonstrates and establishes documented evidence that system functions according to its operational specification in the selected environment.

Performance Qualification (PQ)

Demonstrates and establishes documented evidence that system functions according to a specification and produces results that consistently meet requirements.

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6. Roles and Responsibilities Identify and assign staff possessing the knowledge and authority to perform the following roles as per facility requirements.

Name and Title Role General Responsibilities

Jeff Dragoo Chief Technology Officer Digi-Trax® Corporation

Vendor and Technical Support

Supply the application software, printer and scanner; user manuals, technical sheets, specifications, and technical support.

Internal IT staff at facility

Supply computer meeting technical minimum requirements to run the software, grant tester(s) local administration rights and/or facilitate software and hardware installation per facility policy. If applicable, add thermal label printer to facility’s network.

Validation Coordinator

Update validation plan to meet facility requirements, coordinate test data preparation and review, identify tester(s) and provide testing instructions (Attachment A), notify NMDP of validation dates, coordinate IQ, OQ, and PQ testing, address discrepancies, write final validation summary, and obtain approvals.

Tester 1 Read testing instructions, perform qualification tests, and notify validation coordinator of discrepancies during testing.

Tester 2 (as needed)

Read testing instructions, perform qualification tests, and notify validation coordinator of discrepancies during testing.

Reviewer Review validation testing and supporting documents to ensure test scripts are completed correctly, discrepancies are resolved, and appropriate signatures are captured in test results. Reviewer should be a subject matter expert (SME) on validation and labeling.

Approver(s) Approve Validation Plan prior to execution. Accept validation testing results and validation final summary to approve system for use at facility. Approvers may include the following roles as defined/required by the facility: Executive Director, Medical Director, QA representative.

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7. Scope Add ocular tissue products or additional label sizes as appropriate.

In Scope Validate the installation, operation and performance of:

• Stand-alone CorneaTrax™ ISBT 128 Labeling System. See Section 10 of this Plan for a detailed list of system components.

• Ocular tissue labels for distribution.

o Full thickness Cornea o Precut Cornea for DSEK/DSAEK o Prepared cornea for DMEK/DMAEK o Long-term Preserved Cornea o Sclera o Other processed ocular products

• Label Stock: See Supplies section of this plan.

Out of Scope

• Any product label types, sizes or stock not specifically listed above.

• Label stock material performance as it pertains to adhesion and integrity. This should be tested per facility requirements in a separate validation plan. The following label stock requirements should be met at a minimum:

• Label sticks to product packaging

• Adhesion maintained when label exposed to various usage, storage and transport temperature ranges

• Ink resistant to smearing when exposed to water, bleach, alcohol,

and other chemicals present at facility

• Other environmental conditions for facility

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8. Risk Assessment The following risks and mitigation were identified:

Risk Level (low, med, high) Mitigation Validation failure Low In the event of validation

failure, facility will continue to use the current labeling process and labels.

On-site support not available at individual facilities during validation period

Low Notify Digi-Trax of validation timing to ensure Digi-Trax staff are available to provide validation and technical support.

Risk to facilities that use pre- printed DIN set labels. Potential for same DIN to be assigned to products from two different donations.

High Facility must develop and implement a plan for managing printed DIN set label inventory and use.

Add risk per facility needs. Remove risks that do not apply.

9. Requirements and Specifications

9.1 User Requirements (UR) Describes what the equipment and software is intended to do and all essential requirements. Add additional user requirements specific to facility as needed.

User Requirements: Software Category

1. Ability to enforce password security Security 2. Ability to automatically log a user out after certain period of

inactivity Security

3. Ability to create, configure and assign roles and rights based on security and functional needs

Security

4. Ability to produce and print user activity reports Security 5. Ability to produce ISBT-128 labels at distribution for the ocular products

the bank processes and/or distributes. Standards/regulatory

6. Ability to select ICCBBA product codes Standards/regulatory 7. Ability to produce the following field information in bar code as well

as eye-readable text: DIN, product code, and FIN(P). Eye bank may also choose to encode the expiration date.

Standards/regulatory

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8. Ability to produce product labels meeting EBAA labeling requirements by providing the following label elements:

• Name of source eye bank • Unique tissue identifiers (DIN, Product Code, and FIN(P) • Type of tissue (ISBT 128 Class name) • Additional processing – using ISBT 128 attributes or text • Expiration date • Statement that tissue is intended for single patient application • Statement regarding sterility • Type of storage solution

For short and intermediate-term preserved tissues: • Date and time of donor’s death • Date and time of initial preservation


9. Ability to produce 2D Data Matrix bar codes readable by industry standard bar code scanners


10. Ability to produce eye readable text Standards/regulatory 11. Ability to display death and preservation date and local time Usability 12. Ability to preview label before printing Usability 13. Ability to produce labels on demand Usability 14. Ability to install software from compact disk (CD) Usability 15. Ability to use software with printer and bar code scanner Usability 16. Ability to provide log of printed labels Usability 17. Ability to export print label log to an Excel or PDF file Usability 18. Ability to create a short list of applicable product codes from list of

available products codes based on ICCBBA database Usability

19. Ability to reprint labels that appear exactly as the original label Usability 20. Ability to create and edit facility information Usability 21. Ability to create and edit flag codes Usability 22. Ability to generate or scan donation identification number (DIN) Usability

User Requirements: Printer 23. Ability to print labels on demand Usability 24. Easy set up and drivers provided on CD or downloaded via link Usability 25. Ability to use with CorneaTrax software Usability 26. Ability to change label stock Usability 27. Requires small footprint Usability 28. Ability to print at 300 dpi Usability

User Requirements: Label Stock 29. Label stock loadable in specified printers Usability 30. Printed label is readable and data is complete Usability

User Requirements: Bar Code Scanner 31. Ability to read ISBT 128 bar code symbology Usability 32. Ability to use with CorneaTrax software Usability 33. Lightweight Usability 34. Easy to use Usability 35. Scan window scratch-resistant Usability

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9.2 Design Specifications (DS) Describes the layout of the labels and describes all data fields and features.

Field Name Field Type Description How it appears on

CorneaTrax Labels

1. Donation Identification Number (DIN)

Auto- populated

Contains (FIN) facility identification number, collection year and serial number

Generated when DIN scanned or when user clicks Generate DIN button

Bar code and text

2. Product Code Drop-down list

Product code List derived from facility’s quick pick list

Bar code and text

3. Facility Drop-down list

Source eye bank List derived from facility’s quick pick list

Text

4. Storage Medium

Drop-down list

Storage solution List derived from facility’s quick pick list

Text

5 Storage temp Drop-down list

The software will auto-select the storage temperature if the temperature is defined in the product code. Otherwise the user will need to select this from the drop-down list.

Text

6. Sterile text Drop-down list

Single Patient Use Only and sterility statement

Text

7. ID Number Text Enter old Tissue ID number if desired or leave blank.

Text

8. Secondary processor

Check box Check if facility performs secondary processing. FIN(P) will be generated.

Bar code and text

9. Date/time of death

Checkbox and arrow button

Death date and time including local time zone. Death date and time for UTC automatically generates.

Text

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10. Date/time of preservation

Checkbox and arrow button

Preservation date and time including local time zone. Preservation date and time for UTC automatically generates.

Text

11. Expiration Date Checkbox Check the box labeled Expiration Date

See expiration period field

12. Expiration Period

Radio Buttons

Selection generates expiration date

Barcode and text

Figure 1: CorneaTrax™ Label Example

10. Software, Hardware, and Supplies

10.1 Software

Stand-alone CorneaTrax™ software overview • Manufactured by Digi-Trax Corporation of Lincolnshire, Illinois • Creates ocular tissue labels that meet ISBT-128 requirements • Three levels of security built into CorneaTrax software:

Low security – Role can access label design tab only. User can select label, enter data into label fields and print labels

Medium security – Role can access label design and print log tabs. User can select label, enter data into label fields, print and reprint labels, and view print log table

High security – Role can access and use functionality of low and medium security levels, plus activate and deactivate users, edit facility information, and other administration settings such as automatic time out, and password expiration policies

10.2 Hardware

PC or laptop meeting minimum technical requirements (facility provided) • Installation: requires Administrator privileges • Operating System: Windows 7 or Windows XP Service Pack 3 (SP3) • Memory: 1 GB RAM

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• Hard Disk Space: at least 500 MB of available space • Supporting Software

Microsoft.Net Framework 3.5 Adobe Acrobat Reader 9.0

• Additional Requirements 3 or more USB ports (hardware key, printer, bar code scanner, mouse) CD-ROM drive Mouse

Zebra GX430t thermal printer • Manufactured by Zebra Technologies and supplied by Digi-Trax of Lincolnshire, Illinois • https://www.zebra.com/us/en/support-

downloads/desktop/gx430t.html#mainpartabscontainer_999b=manuals

Gryphon 4400-HC 2D handheld barcode scanner • Manufactured by Datalogic, supplied by Digi-Trax of Lincolnshire, Illinois • http://www.datalogic.com/eng/products/automatic-data-capture/general-purpose-

handhelds/gryphon-i-gd4400-hc-2d-pd-176.html • Features:

Designed to withstand daily cleaning with harsh disinfectant solutions Motionix™ motion-sensing technology for seamless reading mode transitions Highly visible 4-Dot aimer with center cross for targeted scanning Image capture and document scanning capabilities Datalogic’s patented ‘Green Spot’ for good-read feedback USB Certified Kits Available

10.3 Supplies

The label stock is intended to be compatible with the CorneaTrax™ software, printer and bar code scanner listed in this plan. This label stock meets ISBT-128 requirements for size, can be loaded and used in the specified printers, accepts data typed into the CorneaTrax™ software and accepts ink from the specified thermal ribbons.

• Label stock EBAA-41 : 1” x 4”, 1 roll of 500 labels • Thermal printer ribbon RR-CT-G4 (4.33” x 243’)

11. Testing Qualification Overview

Testing will be performed in a complete, verifiable manner, to assure the requirements, design specifications, and characteristics of the system and its components are met. See Attachment A for Testing Instructions.

Each PC or laptop using Stand-alone CorneaTrax™ software must be validated. Each bar code scanner must also be validated. If two or more printers are used at facility, alternate label printing during validation to demonstrate printers work and are compatible with other system components.

https://www.zebra.com/us/en/support-downloads/desktop/gx430t.html#mainpartabscontainer_999b=manuals

https://www.zebra.com/us/en/support-downloads/desktop/gx430t.html#mainpartabscontainer_999b=manuals

http://www.datalogic.com/eng/products/automatic-data-capture/general-purpose-handhelds/gryphon-i-gd4400-hc-2d-pd-176.html

http://www.datalogic.com/eng/products/automatic-data-capture/general-purpose-handhelds/gryphon-i-gd4400-hc-2d-pd-176.html

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Testing will include:

11.1 Installation Qualification (IQ) documents

An IQ protocol shall be executed and approved to provide documented evidence that the equipment was installed as expected. Attachment D describes the activities that will be executed and includes the following sections: • D1: Software and Hardware Checklist • D2: Software and Hardware Installation

11.2 Operational Qualification (OQ) documents

An OQ protocol shall be executed and approved to provide documented evidence that the equipment operates as expected. Attachment E describes the activities that will be tested and includes the following sections:

• E1: Configuration and DIN Set-up

• E2: Security Levels and Incomplete Field Warnings • E3: Generate/Print DIN Set Label Using Blank DIN Label Stock • E4: Scan a DIN to Populate DIN Field in Stand-alone CorneaTrax™ Software

11.3 Performance Qualification (PQ) documents

A PQ protocol shall be executed and approved to provide documented evidence that the software, hardware, and supplies satisfy the user requirements and design specifications. Attachment F describes the activities that will be tested and includes the following sections. • F1: Label Creation • F2: View; Export Print Logs; Edit and Reprint label

11.4 Discrepancy Management

If, during the execution of the validation, a discrepancy is found, take one of the following actions, depending on the nature of the discrepancy:

• If discrepancy is a typographical error or wording clarification in the validation scripts that

does not impact the original intent or acceptance criteria of the script, the validation coordinator should manage the discrepancy per facility procedures.

• If discrepancy is a tester error, including but not limited to, the tester skipping a step or not performing the step as written:

Reprint testing protocol script and repeat script until it passes. • If discrepancy impacts the original intent or acceptance criteria, or represents

software, hardware or supplies functionality error, the validation coordinator or designee should:

Ensure discrepancy is documented on the Discrepancy Form (See Attachment C) and any supporting materials such as screenshots or printouts are attached.

Contact Digi-Trax at [email protected]. Attach discrepancy form and supporting materials.

mailto:[email protected]

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Follow instructions provided by Digi-Trax to resolve discrepancy and document actions taken and results. If discrepancy is resolved, repeat test steps until script is completed successfully.

If discrepancy cannot be resolved, validation coordinator must decide whether or not to continue executing the protocol.

Note that facility reviewers and approvers must review discrepancies and resolution prior to system implementation.

11.5 Acceptance Criteria

All qualification tests must pass and any discrepancies related to functionality must be documented and resolved.

12. Final Validation Summary

The validation coordinator or designee will prepare a final summary after all testing protocols are executed and documented.

The facility’s ISBT 128 project manager and Digi-Trax must be contacted immediately if validation fails.

Final Validation Summary: Stand-alone CorneaTrax™ ISBT 128 Labeling System

Summarize validation activities including IQ/OQ and PQ testing results, discrepancies related to system functionality, and their resolution.

Indicate outcome:

Passed/Acceptable Results Failed/Not Acceptable Summary prepared by: Date:

Summary reviewed by: Date:

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13. Final Validation Acceptance and Approval

Obtain signatures in this section after all testing protocols are successfully executed, reviewed and summarized.

Enter approver name(s) and job title(s) with the appropriate authority to do so. Approvers must sign and date in the spaces provided below.

The following signatures indicate final acceptance of the Stand-alone CorneaTrax™ ISBT 128 Labeling system for use at facility.

Approver Name Job Title Sign

Date

14. References • Digi-Trax, User’s Guide for CorneaTrax (http://www.digi-trax.com/) • ICCBBA, ST-001 ISBT 128 Standard Technical Specification , current version • ICCBBA, ST-002 ISBT 128 Standard Terminology for Medical Products of Human Origin, current

version • ICCBBA, IG-040 Implementation Guide: Use of ISBT 128 in North American Eye Banks, current

version • ICCBBA, ISBT 128 Product Description Code Database, current version • Zebra, GX430t™ Desktop Thermal Printer User Guide, www.zebra.com , current version • Datalogic, Gryphon GD4400-HC 2D Quick Reference Guide, current version

http://www.digi-trax.com/

https://www.iccbba.org/docs/tech-library/technical/st-001-isbt-128-standard-technical-specification-v5.3.0.pdf

https://www.iccbba.org/docs/tech-library/technical/standardterminology.pdf

http://www.zebra.com/

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Attachment A. Testing Instructions

Tester Instructions 1. Read Objective, Acceptance Criteria and Special Instructions/Preparation. 2. Record tester name in Tester Assigned field. 3. Enter run number in Run # field. “Run number” refers to the number of times the script is

performed. For instance, the run number would be “1” for the first time the script is performed, “2” for the second, and so on.

4. For IQ scripts (D.1-D.2), OQ scripts (E.1-E.4) and PQ script F.2.

4.1. Perform steps as written. 4.2. Initiate a discrepancy form per Attachment C, as needed. 4.3. For each step, record required information as requested and document outcome for each

step in Actual/Recorded Results column. Pass - Expected Results obtained Fail - Expected Results NOT obtained NA -step does not apply to facility/environment

4.4. For test script, determine if Acceptance Criteria was met. Complete and document outcome at end of each test script in Results section: Test Passed with no discrepancies Test passed with discrepancies. Discrepancies resolved. Test failed. Discrepancies not resolved

4.5. In Comments section, list any failed step numbers, associated discrepancy number(s), and discrepancy status(es), and other related comments as appropriate.

4.6. Sign and date Performed by line in results section following each script.

5. For PQ script F.1. 5.1. Record Tester Assigned, laptop or PC, printer and scanner serial/identification

numbers as indicated in the fields preceding F.1 script steps. 5.2. Locate and print F.1. PQ Results: Label Creation (Data Entry by Tester), found at

the end of the F.1 script (after step F.1.40). A Results page is needed for every data record and every run.

5.3. Complete Data Record # and Run # fields. 5.4. Perform steps as written using test data provided by the validation coordinator. 5.5. Initiate a discrepancy form per Attachment E, as needed. 5.6. Rather than documenting the result of each step, record the outcome of the whole script

(steps F.1.1. – F.1.26) on the F.1. PQ: Results page. 5.6.1. As steps are performed, list any failed step numbers, associated discrepancy

number(s), and discrepancy status(es), and other comments as appropriate. 5.6.2. Document the outcome for the particular run: Test passed with no discrepancies Test passed with discrepancies. Discrepancies resolved. Test failed. Discrepancies not resolved

5.7. Affix/Attach label(s) in space indicated. Use second side of form as needed for data records with multiple divisions and attach additional pages as needed.

5.8. Sign and date Performed by and Date fields.

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Reviewer Instructions 1. Review completed test scripts to ensure all test steps are executed, outcomes are recorded, and

tester signed results summary table at the end of each script section. 2. For PQ test scripts, test data from the spreadsheet described in Attachment B will be used. Compare

the test data from the spreadsheet to test script results. 3. If a step outcome, signature, or supporting documentation is missing or incorrect, follow up with

tester to complete, correct or re-execute script. 4. Review all discrepancy forms and ensure they are documented appropriately, and signed and

dated. 5. Once complete, sign and date Reviewed by field on the results table and related discrepancy

forms.

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Attachment B. Test Data (Excel Spreadsheet) Preparation Instructions

Test data will be used to populate label fields as part of performance qualification (PQ) testing. A test data record is needed for every product label that will be used at the facility.

Develop test data in collaboration with a subject matter expert. A different subject matter expert should review the test data.

1. Review the current listing of ISBT 128 Product Description Code Database, from the ICCBBA

website. 2. Determine which product codes will be used at facility. 3. Create and save a validation spreadsheet with all product codes to be used as the test data

scripts. 4. Print test data on 11 x 17 paper. Note that the test data needed to create a 4x1 base label is

presented vertically (one record per column). 5. Submit test data to Reviewer. Update test data if requested by reviewer. 6. Document (sign and date) test data preparation below and secure reviewer(s) signature(s).

The following signatures from SME with the appropriate knowledge and experience indicate preparation and review of test data (Excel spreadsheet).

Name Role Signature Date

Test Data Preparation

Test Data Preparation

Test Data Reviewer

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Attachment C. Discrepancy Resolution Form and Instructions

1. Print forms as needed 2. Record test step number 3. Assign Discrepancy Number sequentially,

starting with 1 4. Describe discrepancy 5. Attach supporting documents, adding

step and page numbers to each page 6. Notify Digi-Trax of discrepancy

7. Describe actions taken to resolve discrepancy

8. Check box to indicate resolution status 9. Sign and date form for Completed by 10. Attach the Discrepancy Resolution Form and

supporting documentation to each test script as completed

DISCREPANCY RESOLUTION FORM Test Step Number: Discrepancy Number:

Describe discrepancy:

Describe actions taken to correct / resolve:

Resolved Unresolved : Explain below

Completed by (signature):

Date:

Reviewed by (signature):

Date:

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Objective Complete the following checklist to confirm all system components are

received

Acceptance Criteria

All items listed must be checked to indicate item is present and undamaged, or it is marked “NA.” If item is missing or damaged, contact Digi-Trax to order or replace

Special Instructions/ Preparation:

This script should be run by a tester with local system administrator rights. The validation coordinator may have to request local administrator rights in advance from the facility’s internal IT department for the computer on which the system will be installed in advance.

Print additional copies of script as needed to validate each PC or laptop, printer and bar code scanner.

Tester Assigned:

Run #:

Attachment D. Installation Qualification (IQ)

D.1. Software and Hardware Checklist

Item Check the box if item is present.

If missing or damaged, contact Digi-Trax.

CorneaTrax software. The following should be present for each license ordered:

• CD titled CorneaTrax (includes CorneaTrax Installation and User’s Guide PDF files )

□

• CorneaTrax USB License Key (note that key may be packed in separate bag)

□

Thermal printer and components. The following should be present for each printer ordered:

• Zebra thermal printer - GX430t

Find the serial number (S/N), by locating and reviewing the large manufacturer’s label affixed to the bottom of the printer.

S/N (manufacturer’s serial number):

____________________

• USB cable □ • Power adaptor □

• CD titled Zebra Specialty Printing Solutions: Software and Documentation for Desktop Printers GX Series CD.

□

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• Zebra GX430t printed guide □ • Cardboard ribbon core (notched roll) □

Label Stock and Ribbons

• EBAA-41 4”x1” label stock □ • Ribbon (4.33” x 243’) □

Bar code scanner and components. The following should be present for each scanner ordered:

• Gryphon 4400-HC 2D barcode scanner

Locate identification sticker above scanner button. Document scanner part number (P/N) and serial number (S/N)

P/N ___________

S/N or unique identifier assigned per facility processes:

__________________________

• USB cable (Note that cable may be packed in a separate bag) □

• Gryphon 4400-HC 2D Quick Start Guide (printed) □

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D.1. IQ Results: Software and Hardware Checklist

Acceptance criteria met?

Test passed with no discrepancies.

Test passed with discrepancies. Discrepancies resolved.

Test failed. Discrepancies NOT resolved.

Performed by Date

Reviewed by Date

Comments

List any failed steps, associated discrepancy number(s) and discrepancy status(es) and other notes as appropriate:

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D.2. Software and Hardware Installation

Objective

Install system components and ensure minimum technical specifications are met in the specified environment.

Acceptance Criteria

All steps must be successfully completed one time through for each PC or laptop that will use CorneaTrax software, each printer that will print labels and each scanner that will be used.


This script should be run by a tester with local system administrator rights (which allows the tester to install software and hardware). Tester and/or validation coordinator should consult with internal IT staff as needed to assess facility- provided PC or laptop properties and ensure tester has local administrative rights.

Test script includes instructions for facility-supplied PC or laptop.

Print additional copies of script as needed to validate each PC or laptop, printer and bar code scanner.

Tester Assigned: Run #:

Step Action Expected Result Actual/Recorded Result PC or laptop computer

D.2.1. Record PC or laptop identifiers. NA Manufacturer _ _

Model _

_ _ Serial Number (S/N) or other unique identifier assigned per facility processes

D.2.2. Confirm with IT department or applicable Subject Matter Expert (SME) that facility-provided PC or laptop meets minimal technical requirements listed in section 10.2 of this plan.

Computer meets requirements. Circle one:

Pass Fail

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Step Action Expected Result Actual/Recorded Result

D.2.3. Confirm the current date, time and time zone setting of PC or laptop are appropriate for current location.

Date, time and time zone are appropriate for current location.

Circle one:

Pass Fail

D.2.4. Confirm tester is assigned administrator rights on desktop or laptop where labeling system will be installed.

User is assigned local administration rights.

Circle one:

Pass Fail

Stand-alone CorneaTrax software


D.2.5. Install Stand-alone CorneaTrax software (including Print Engine and MS Report Viewer) from supplied CD. Follow prompts to initiate and complete installation.

Notes: Tester may have to wait up to 10 minutes for installation to complete. PC or laptop may appear inactive during installation.

“CorneaTrax installed successfully” screen displays.

Circle one:

Pass Fail

D.2.6. Remove CD from drive. CD is removed. Circle one: Pass Fail

D.2.7. Plug USB license key into USB drive of computer and record number on key fob.

USB key lights up. Number printed on key fob:

_ Circle one:

Pass Fail

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Thermal Printer (refer to User Guide for diagrams and further guidance as needed)


D.2.8. Circle appropriate printer model and record serial number or unique identifier of printer.

If printer will be networked (shared by multiple PCs or laptops), see manufacturer’s instructions and follow internal facility processes for setting up a network printer. Mark Thermal Printer section “NA” (steps F.2.9.– F.2.20) in Actual/Recorded Results column for this step.

NA _ _ S/N (manufacturer’s serial number or unique identifier assigned per facility processes)

Thermal Printer section is not applicable (NA). See manufacturer’s instructions and set up printer per facility processes.

D.2.9. Access User Guide for appropriate model number of printer at www.zebra.com.

Refer to User Guide as needed for diagrams and manufacturer’s instructions as needed.

User Guide is located. Circle one:

Pass Fail

D.2.10. Attach power adapter and connect to power supply per manufacturer’s instructions.

Note: Do not connect printer to PC or laptop yet.

Power adapter is attached and power supply is attached to printer.

Circle one:

Pass Fail

D.2.11. Load label stock per manufacturer’s instructions.

Note that label stock should be loaded so label is face-up as it comes out of the printer.

Label stock is loaded. Circle one:

Pass Fail

D.2.12. Load ribbon and cardboard ribbon core per manufacturer’s instructions.

Ribbon and notched core are loaded.

Circle one:

Pass Fail

D.2.13. Print configuration test label from printer per manufacturer’s instructions.

Test label prints. Circle one:

Pass Fail

http://www.zebra.com/

25


D.2.14. Insert Zebra Specialty Printing Solutions CD into CD-Rom drive of computer.

Note: It may take a few minutes for CD menu to display.

CD is inserted successfully. Circle one:

Pass Fail

D.2.15. Select printer model from drop-down menu.

Appropriate printer model is selected and Zebra CD menu displays.

Circle one:

Pass Fail

D.2.16. Select Run Zebra Setup Utilities from Zebra CD menu.

System Prepare Wizard displays. Circle one:

Pass Fail

D.2.17. Make selections and follow System Prepare Wizard prompts as appropriate.

Printer model displays as being installed.

Circle one:

Pass Fail

D.2.18. If not already connected, connect printer to a USB drive on PC or laptop using USB cable.

Printer is connected to laptop or PC via USB cable.

Circle one:

Pass Fail NA

D.2.19. Click Close button to close Zebra Setup Utilities. Click X to close Zebra CD menu.

Zebra Setup Utilities closes. Zebra CD closes.

Circle one:

Pass Fail

D.2.20. Click Start Button on PC or laptop and select Devices and Printers or Printers and Faxes.

List of printers or icons display. Circle one:

Pass Fail

D.2.21. Locate and hover mouse over printer icon or listing. Right-click to display menu. Select Printing Preferences.

Printing Preferences window displays.

Circle one:

Pass Fail

D.2.22. Change configuration settings so that Speed is 2.0 and Darkness is 30.

Fields accept values. Circle one:

Pass Fail

26

BAR CODE SCANNER


D.2.23. Locate Datalogic, Gryphon GD4400-HC 2D Quick Reference Guide

Complete Step 1, Attach Cable to Scanner and to a Host. Complete Step 2, Configure the Interface.

Complete Step 3 as needed, to configure the reader.

Scanner is connected to PC or laptop and scanner emits three beeps.

Scanner S/N or unique identifier assigned per facility processes

_

Circle one:

Pass Fail

27

D.2. IQ Results: Software and Hardware Installation





Performed by Date

Reviewed by Date

Comments


28

Attachment E. Operational Qualification (OQ)

E.1. Configuration and DIN Set-up

Objective

Configure software to establish the following elements:

• DIN (which includes the FIN as assigned by ICCBBA, flag code of 00, and set 6-digit serialized starting number for labels)

• Product code quick pick list (list of product codes to be used by facility) • Collection facility name and address • Processing facility name and address • Auto-logout (logs user out after X minutes of inactivity) • Set up tester user accounts for remaining test scripts

Acceptance Criteria

All steps must be successfully completed one time through for each PC or laptop that will use CorneaTrax software, each printer that will print labels and each scanner that will be used.


This script must be run by a tester with local system administrator rights.

Validation coordinator must provide the tester with the following information in writing and attach it to this script:

• DIN (which includes the FIN as assigned by ICCBBA, flag code of 00 or other value as determined by facility, and set 6-digit serialized starting number for labels)

• List of product codes to be used by facility (will be used to create quick pick list)

• Source eye bank facility name and address • Processing facility name • Auto-logout time period (logs user out after X minutes of inactivity)

Print additional copies of script as needed to validate each PC or laptop.



E.1.1. Record PC or laptop serial or unique identification number.

NA _ S/N (manufacturer’s serial number or unique identifier assigned per facility processes)

29


E.1.2. Open CorneaTrax using shortcut on desktop.

CorneaTrax Login screen appears.

Circle one:

Pass Fail

E.1.3. Complete the following fields as follows and click Log In button.

User Name: Administrator

Password: admin

User is successfully logged in. Circle one:

Pass Fail

E.1.4. Locate version number in the bottom right, next to the Exit button.

Version displayed in window is 1.0.

Record version number displayed in label design screen:

_

Circle one:

Pass Fail

E.1.5. Click DIN Setup. Dropdown menu displays. Circle one:

Pass Fail

E.1.6. Enter FIN by clicking on text field directly below FIN and entering ICCBBA-assigned number.

Field accepts FIN entered by tester.

FIN:

Circle one:

Pass Fail

E.1.7. Locate Year field. Year displays as “15.” Circle one:

Pass Fail

30


E.1.8. If Year field is pre-populated with current year, circle “Pass” in Actual/Recorded Result column and proceed to next step.

If Year field does not display current year, correct field by clicking outside the DIN Setup menu to exit it. Click Generate DIN button.

Re-select DIN Setup. Year field displays current year.

Year displays correctly as current year.

Circle one:

Pass Fail NA

E.1.9. Enter Serialized Number by clicking on text field directly below Serialized Number (6 Digits).

Field accepts number entered by tester.

Record Serialized Number (6 digits):

Circle one:

Pass Fail

E.1.10 Locate Flag Character and observe default value of “00.”

If facility will use flag characters as part of DIN, update field as appropriate.

Flag Character field displays correct value.

Flag Character: _

Circle one:

Pass Fail

E.1.11 Select Product Codes tab. Edit Product Codes screen displays.

Circle one:

Pass Fail

E.1.12 Locate Enter Code to Add or Delete text box. Enter first 5-digit ICCBBA product code number and click Add/Del Code. Click OK button.

Repeat step until all product codes to be used at facility are entered into Product Code Quick Pick List.

Message appears that “Product successfully added to Quick Pick List.”

Record Product Code(s) number added (e.g., V0003):

__

__

__

__

__

__ Attach list if needed.

Circle one:

Pass Fail

31


E.1.13 Choose Facilities tab. Edit Facilities window appears. Circle one:

Pass Fail N/A

E.1.14 In Source Facility section, select Digi-Trax row. Depress Delete key on keyboard to remove Digi-Trax.

Digi-Trax is deleted from Facility section of Facilities tab.

Circle one:

Pass Fail

E.1.15 If facility will label ocular products, enter Source Facility name in first column displayed, enter address in second column and enter city, state and zip code in third column displayed.

Data entry accepted. Circle one:

Pass Fail N/A

E.1.16 Click Save Changes button. Changes saved. Circle one:

Pass Fail N/A

E.1.17 Select the User Management tab. User Management screen displays.

Circle one:

Pass Fail

E.1.18 Set up user account(s) for tester(s):

Complete the following fields as appropriate:

First Name: Tina Last Name: Tester Select “2” for Security Level Password: Level2

Note: Passwords are not case- sensitive.

Fields accept data. Circle one:

Pass Fail

E.1.19 Select Add User button to save user’s information.

User saved. Circle one:

Pass Fail

32


E.1.20 Enter the following to add a Level 1 (low security) tester account.

Enter the following:

First Name: Tom Last Name: Tester Select “1” for Security Level Password: Level1

Additional user added. Circle one:

Pass Fail

E.1.21 Select Add User button to save user account information.

User(s) saved. Circle one:

Pass Fail

E.1.22 Configure auto-logout. Enter “2” in Auto-logout field.

Field accepts data. Circle one:

Pass Fail

E.1.23 Depress Tab key on keyboard to place cursor in First name field.

Cursor in First name field. Circle one:

Pass Fail

E.1.24 Wait 2 minutes. Tester is automatically logged out.

Circle one:

Pass Fail

E.1.25 Log into CorneaTrax as administrator:

User ID: Administrator

Login Password: admin

User is logged in. Circle one:

Pass Fail

E.1.26 Click User Management tab, if tab is not displayed

User Management tab displays. Circle one:

Pass Fail

E.1.27 Enter “0” in Auto-Logout field or number of minutes as per facility requirements.

Field accepts data. Circle one:

Pass Fail

33


E.1.28 Select Label Design tab and select Exit button to log out and close application.

User is logged out and application closes.

Circle one:

Pass Fail

E.1.29 Open CorneaTrax software using desktop shortcut.

Log in as:

Name: Administrator

Password: admin

Tester is logged in. Circle one:

Pass Fail

E.1.30 Click User Management tab. User Management tab displays. Circle one:

Pass Fail

E.1.31 Locate and click on Tina Tester to select account. Click Reset Password/Security Level button.

Change Password pop-up window displays.

Circle one:

Pass Fail

E.1.32 Change Tina Tester password. New Password: apple1

Confirm New Password: apple1

Click Save button.

Click Exit button in pop-up window.

Password is changed and Change Password pop-up window closes.

Circle one:

Pass Fail

E.1.33 Locate and click on Tom Tester to select account. Click Reset Password/Security Level button.

Change Password pop-up window displays.

Circle one:

Pass Fail

34


E.1.34 Change Tom Tester password. New Password: orange1

Confirm New Password: orange1

Click Save button.

Click Exit button in pop-up window.

Important Note: It is strongly recommended the facility administrator update the administrator account’s login password per facility requirements once validation testing is successfully completed.

Password is changed and Change Password pop-up closes.

Circle one:

Pass Fail

E.1.35 Select Label Design tab and click Exit button to log out and close application.

User is logged out and application closes.

Circle one:

Pass Fail

End

35

E.1. OQ Results: Configuration and DIN Set-up





Performed by Date

Reviewed by Date

Comments

Instructions for Reviewer: To effectively determine if the quick pick product list, DIN set up, collection and processing facilities are set up correctly, ask system administrator to log in and review the information: DIN Set Up fields, Product Codes tab, and Facilities tab.


36

E.2. Security Levels and Incomplete Field Warnings

Objective

Confirm security Level 1 tester may only access Label Design tab; Level 2 tester may only access Label Design and Print Log tabs; and that the appropriate warning messages display when key Label Design fields are not completed.

Acceptance Criteria

All steps must be successfully completed one time through for each PC or laptop that will use CorneaTrax software.



Tester Assigned:

Run #:






Circle one:

Pass Fail

E.2.3. Log in using security Level 1 user account.

User Name: Tom Tester

Password: orange1


Pass Fail

E.2.4. Click Product Codes Tab. Pop-up message appears: “You have insufficient access privileges for that tab.”

Circle one:

Pass Fail

E.2.5. Click OK button. Pop-up message closes. Circle one:

Pass Fail

E.2.6. Click Facilities tab. Pop-up message appears: “You have insufficient access privileges for that tab.”

Circle one:

Pass Fail


Pass Fail

37


E.2.8. Click Print Log Tab. Pop-up message appears: “You have insufficient access privileges for that tab.”

Circle one:

Pass Fail


Pass Fail

E.2.10. Click User Management Tab. Pop-up message appears: “You have insufficient access privileges for that tab.”

Circle one:

Pass Fail


Pass Fail

E.2.12. Click Generate DIN button. DIN populates in field. DIN displays on preview screen as bar code and text in upper left quadrant of label.

Circle one:

Pass Fail

E.2.13. Complete Source Eye Bank by choosing your eye bank from drop- down menu.

Field is correctly populated. Eye bank name and address appears in preview screen in upper left quadrant of label

Circle one:

Pass Fail

E.2.14. Click Print button. Pop-up appears with warning message that states “Please Select a Product Code.”

Circle one:

Pass Fail

E.2.15. Click OK button. Pop-up message disappears. Circle one:

Pass Fail

E.2.16. Select a Product Code by highlighting it in list. Record product selected.

Highlighted product code appears in field.

Product code displays on preview screen as bar code and text on left side of label.

_ Selected product code

Circle one:

Pass Fail

38


E.2.17. Click Print button. Label Prints Circle one:

Pass Fail

E.2.18. Click Exit button. Note: Clicking the Exit button will “clear” data as well as log user out and close CorneaTrax application.

Tester is logged out. Circle one:

Pass Fail



Circle one:

Pass Fail

E.2.20. Tester logs in using Level 2 user account.

User Name: Tina Tester

Password: Apple1


Pass Fail

E.2.21. Click Product Codes Tab. Pop-up message appears: “You have insufficient access privileges for that tab.”

Circle one:

Pass Fail


Pass Fail

E.2.23. Click Facilities tab. Pop-up message appears: “You have insufficient access privileges for that tab.”

Circle one:

Pass Fail


Pass Fail

39


E.2.25. Click Print Log Tab. Print Log tab displays. Circle one:

Pass Fail

E.2.26. Click User Management Tab. Pop-up message appears: “You have insufficient access privileges for that tab.”

Circle one:

Pass Fail


Pass Fail


Tester is logged out and CorneaTrax is closed.

Circle one:

Pass Fail

End

40

E.2. OQ Results: Security Levels and Incomplete Field Warnings





Performed by Date

Reviewed by Date

Comments


41

E.3. Scan a DIN to Populate DIN Field in Stand-alone CorneaTrax Software

Objective

Scan a DIN label printed at facility using blank DIN set stock to populate DIN field in Stand-alone CorneaTrax software.

Acceptance Criteria

All steps must be successfully completed one time through for each PC or laptop that will use CorneaTrax software and bar code scanner.


Print additional copies of script as needed to validate each PC or laptop and bar code scanner.



E.3.1. Indicate label stock facility will use to generate DIN for product labels.

NA □ EBAA-41 Label Stock

□ Other: _______________


NA Laptop or PC S/N (manufacturer’s serial number or unique identifier assigned per facility processes)

______________________

E.3.3. Record scanner serial or unique identification number.

NA Scanner or PC S/N (manufacturer’s serial number or unique identifier assigned per facility processes)

______________________

E.3.4. Open CorneaTrax software using desktop shortcut.


Circle one:

Pass Fail

E.3.5. Log in using Level 1 user account.


Password: orange1

User is logged in as Tom Tester. Circle one:

Pass Fail NA

42

E.3.6. Scan DIN as applicable for facility.

DIN field is populated and displays on preview screen.

Circle one:

Pass Fail NA

E.3.7. Compare scanned eye readable DIN to DIN displayed in preview screen.

Eye readable DIN values match. Circle one:

Pass Fail NA


Tester is logged out and CorneaTrax is closed.

Circle one:

Pass Fail

End

43

E.3. OQ Results: Scan a DIN to Populate DIN Field in Stand-alone CorneaTrax Software





Performed by Date

Reviewed by Date

Comments


44

Objective

Demonstrate the Stand-alone CorneaTrax ISBT 128 Labeling System consistently produces labels that meet user requirements and design specifications outlined in this validation plan.

Acceptance Criteria

All steps must be successfully completed for each PC or laptop that will use CorneaTrax software and each printer that will print 4x1 labels.


Run script using the test data (Excel spreadsheet) provided by validation coordinator. Note that test data must be prepared and reviewed prior to running PQ scripts as per Attachment B.

Perform script in order to produce a minimum of 1 label for each product label facility will use. In other words, each data record in the spreadsheet must be used at least 1 time.

Important Note: Validation testing results for each data record and run will be captured on F.1. PQ Results: Label Creation, which can be found at the end of this script. Print copies of F.1. PQ Results page as needed as a separate results page is needed for every data record and run.

Print additional copies of script as needed to validate each PC or laptop and 4x1 printer.

Tester Assigned:

Laptop or PC Serial Number or Unique Identifier

Printer Serial Number or Unique Identifier

Scanner Serial Number or Unique Identifier

Attachment F. Performance Qualification (PQ)

F.1. Label Creation

Step Action Expected Result

F.1.1. Open CorneaTrax software using desktop shortcut.


F.1.2. Log in using Level 1 user account.


Password: orange1

Tester is logged in.

45


F.1.3. Populate DIN field. If facility will use software to generate DIN, click Generate DIN button.

If facility will receive tissue labeled with a pre-printed DIN, scan appropriate DIN label. Press Tab key to refresh preview screen.

DIN populates in field. DIN displays on preview screen as bar code and text in upper left quadrant of label.

F1.4. Select Facility: Source Eye Bank from a drop-down menu per test data.

Facility name appears in field and matches test data. Facility name and address display on preview screen in upper left quadrant.

F.1.5. Select Product Code from drop-down menu per test data.

Note that test data will list a 5-digit product code, but CorneaTrax menu items for Product Code field will include additional product descriptors.

Product code appears in field and matches test data.

Product code (five-digits plus three digit division or pack code) and other descriptors display on preview screen as bar code in upper left and text in upper right quadrant.

F.1.6. Select Storage Medium from drop-down menu per test data. Depress Tab key on keyboard to refresh preview screen.

Field is populated and matches test data.

Storage medium displays text in upper right quadrant of label.

F.1.7. Select Storage Temperature from drop-down

menu per test data. Depress Tab key on keyboard to refresh preview screen.

Field is populated and matches test data. Storage temperature displays text in lower right quadrant of label. F.1.8. Select Sterile Text from drop-down menu per test

data. Depress Tab key on keyboard to refresh preview screen.

Field is populated and matches text data. Text appears in lower left quadrant.

F.1.9. Leave ID Number field blank or enter tissue ID number per test data.

Field remains blank or accepts data entry and matches test data.

If ID Number field is left blank, preview screen does not update. If ID Number field is completed, the number entered will appear as text in upper right quadrant of label preview screen.

46


F.1.10. Locate Secondary Processor checkbox. Check box or leave blank per test data.

Checkbox selection matches test data. If Secondary processor box checked, processor field appears next to checkbox. If Secondary processor box unchecked, additional processor field does not appear next to checkbox.

F.1.11. If Secondary Processor checkbox was checked in previous step, then enter the FIN(P) test data into the Processor field. The FIN(P) field will auto-populate with the eye bank’s FIN defined in the DIN setup, but can be modified if necessary.

Field accepts entry and matches test data. Processor displays on preview screen as bar code and text in upper left quadrant of label.

F.1.12. Click the check box called Date/Time of Death. Edit death date and time field to match test data.

• Click to place cursor on month displayed • Use up and down arrow buttons to modify

month • Click to place cursor on day displayed • Use up and down arrow buttons to modify

day • Click to place cursor on year displayed • Use up and down arrow buttons to modify

year • Click to place cursor on hour displayed • Use up and down arrow buttons to modify

hour • Click to place cursor on minute displayed • Use up and down arrow buttons to modify

minute

Box is checked and date/time displayed in field matches test data.

Preview screen updates to display “Date/Time of Death” followed by selected date and time displayed in local time zone (e.g., EST) as text

47


F.1.13. Click to check box called Date/Time of Preservation. Edit preservation date and time field to match test data.




year • Click to place cursor on hour displayed • Use up and down arrow buttons to modify

hour • Click to place cursor on minute displayed • Use up and down arrow buttons to modify

minute

Box is checked and date/time displayed in field matches test data.

Preview screen updates to display “Date/Time of Preser:” followed by selected date and time displayed in local time zone (e.g., EST) as text.

F.1.14. Check the Expiration Date checkbox. Box is checked and date displayed in field matches test data and will be displayed in bar code

F.1.15. Choose radio button for Select Expiration Date Period field per test data.

If 14 days is selected, the software automatically calculates the expiration date. Confirm auto-calculation is 14 days from date and time of death.

If 1 Year is selected, the software automatically calculates the expiration date. Confirm auto- calculation is 1 year from date and time of death.

If 2 Years is selected, the software automatically calculates the expiration date. Confirm auto- calculation is 2 years from date and time of death. If 5 Years is selected, the software automatically calculates the expiration date. Confirm auto- calculation is 5 years from date and time of death.

If Custom is indicated by test data, go to next step.

Radio button selection matches test data. If 14 Days selected, auto-calculation appears as text in lower right quadrant of preview screen is correct.

If 1 year selected, auto-calculation appears as text in lower right quadrant of preview screen is correct.

If 2 years selected, auto-calculation appears as text in lower right quadrant of preview screen is correct.

If 5 years selected, auto-calculation appears as text in lower right quadrant of preview screen is correct.

48


F.1.16. If Custom indicated by test data, modify expiration date to match test data:




year If Custom is not indicated by test data, step is not applicable. Proceed to next step.

Expiration Date displayed in field matches test data.

Expiration Date appears as text in lower right quadrant in preview screen.

F.1.17. Locate and review value for Label Quantity and update field per test data.

Tester locates value for Label Quantity field.

F.1.18. If printing a single label, the pack code will be whatever is entered in the Pack Code Box.

If specifying a quantity of labels, select either: • Increment the Pack Code (default). Each label

printed will increment the pack code by one (i.e., 001, 002, 003, etc.)

• If Disable Auto-Increment of Pack Code is checked, the pack code will remain the same for each label printed (i.e., 001, 001, 001, etc.)

Pack code displayed matches test data.

F.1.19. Make selection for Printer from drop-down menu. Selection matches test data.

F.1.20. Select Print button to print label. Label prints.

F.1.21. Retrieve printed label(s) and examine to compare to test data.

Ink is legible and information is not cut off or running off edge of label. Information on printed label matches test data and expected results in this script.

F.1.22. Click Exit button to log out and close software. User is logged out.

F.1.23. Enter data record number, run number, and affix printed label(s) in the box at the end of this script.

NA

End

49

F.1. PQ Results: Label Creation

Data Record #: (From Row 1 of Excel Spreadsheet)

Run #:

Performed by: Date:

Results: Test passed with no discrepancies.




Affix/Attach Label Here (use back of form as needed)

Reviewed by: Date:

50

PQ: F.1. Label Creation Test Data Record Results continued


Run #:

Affix/Attach Label Here

Affix/Attach Label Here

Reviewed by: Date:

51

F.2. View; Export Print Logs; Edit and Reprint Label

Objective

Demonstrate that print log report can be accessed by Level 3 security test user (admin). Level 3 tester will view and export print log to Excel and PDF files. Level 2 user will view print log, edit and reprint a label.

Acceptance Criteria

All steps must be successfully completed one time through for each PC or laptop that will use CorneaTrax software.


Important Note: Microsoft Excel must be pre-loaded onto PC or laptop being validated in order to export print logs to an Excel file. If PC or laptop does not have Excel and/or facility will not export print logs to Excel, mark Actual/Record result for appropriate steps in this script as “NA.”


Tester Assigned:


Run #:


F.2.1. Record PC or laptop serial or unique identification number.




Circle one:

Pass Fail

F.2.3. Tester logs in using Level 3 user account.

User Name: Administrator

Password: Admin

User is logged in as Administrator.

Circle one:

Pass Fail

F.2.4. Select Print Log tab. View Print Log screen displays. Circle one:

Pass Fail

F.2.5. View print log. Locate print log row for a selected data record. Compare print log data fields to label produced for data record during F.1.

Data matches. Print log row ID#_ _

Data record # _ _

Circle one:

Pass Fail

52


F.2.6. Select View Print Log Report button. View Print log displays. Circle one:

Pass Fail

F.2.7. Locate Start Date and End Date fields. Change to today’s date if not already displayed.

Fields display today’s date. Circle one:

Pass Fail

F.2.8. Click Go button. Report screen refreshes. Circle one:

Pass Fail

F.2.9. Click Save icon and choose Excel to export Print Log Report to an Excel file.

Exporting window pops up and Save As screen appears.

Circle one:

Pass Fail NA

F.2.10. Rename file as “F2 Print Log Report.”

Select desktop or file folder location for “Save in Location” and click Save button.

Print log report is saved as Excel file. Circle one:

Pass Fail NA

F.2.11. Go to desktop, locate Excel file called “F2 Print Log Report” and Open it.

Print log displays as Excel file. Circle one:

Pass Fail NA

F.2.12. Close Excel file. Excel file is closed. Circle one:

Pass Fail NA

F.2.13. In Print Log Report screen, click Save icon and choose Acrobat (PDF) file to export Print Log Report to an Adobe PDF file.

Exporting window pops up and Save As screen appears.

Circle one:

Pass Fail

F.2.14. Rename file as “F2 Print Log Report,” select Desktop for Save in Location, and click Save button.

Print log report is saved to desktop as PDF.

Circle one:

Pass Fail

F.2.15. Go to desktop, locate PDF file called “F2 Print Log Report” and Open it.

Print log displays as PDF. Circle one:

Pass Fail

F.2.16. Close file. File closes. Circle one:

Pass Fail

53


F.2.17. Click X to close Print Log Report window.

Print Log Report window closes. Circle one:

Pass Fail

F.2.18. Click X to log out. User is logged out and CorneaTrax closes.

Circle one:

Pass Fail



Circle one:

Pass Fail

F.2.20. Tester logs in using Level 2 user account.

User Name: Tina Tester

Password: Apple1

User is logged in as Tina Tester. Circle one:

Pass Fail

F.2.21. Select Print Log tab. View Print Log screen displays. Circle one:

Pass Fail

F.2.22. Select same print log row as used above (step F.2.5) and click Get Data button.

Label Design tab screen appears with data from selected label.

Circle one:

Pass Fail

F.2.23. Edit data by changing ID number to “9999”. Depress Tab key on keyboard to refresh preview screen.

“Edited” displays in ID number field.

Circle one:

Pass Fail

F.2.24. Click Print button. Label prints. Circle one:

Pass Fail

F.2.25. Examine edited printed label and compare to label printed in F.1.21.

ID field will show 9999 printed in step directly above.

All other data on the labels match.

Circle one:

Pass Fail

F.2.26. Select Print Log tab if not already displayed.

View Print Log screen displays. Circle one:

Pass Fail

54


F.2.27. Compare edited printed label and print log data.

Data on edited printed label match print log data.

Circle one:

Pass Fail

F.2.28. Click Label Design tab and Log Out (located in upper left of screen below Facilities tab).

User is logged out. Circle one:

Pass Fail

F.2.29. Enter test data record number, run number, and affix printed labels (re-printed and edited) in the boxes at the end of this script.

NA NA

End

55

F.2. PQ Results: Reprinted Label


Run #:


Affix Label Here

F.2. PQ Results: Edited Label


Run #:


Affix Label Here

Reviewed by: Date:

56

F.2. PQ Results: View; Export Print Logs; Edit and Reprint Label





Performed by Date

Reviewed by Date

Comments

Date post:	04-Sep-2021
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