R A U L S O T O , M S C , C Q EI V T O R L A N D O 2 0 1 7
VALIDATION OF MANUFACTURINGEXECUTION SYSTEMS (MES)
1A S Y S T E M S D E V E L O P M E N T L I F E C Y C L E ( S D L C ) A P P R O A C H
• The contents of this presentation represent the opinion of the speaker; and not necessarily that of his present or past employers.
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ABOUT THE AUTHOR
• 20+ years of experience in the medical devices, pharmaceutical, biotechnology, and consumer electronic industries
• MS Biotechnology, emphasis in Biomedical Engineering• BS Mechanical Engineering• ASQ Certified Quality Engineer
• I have led validation / qualification efforts in many scenarios:• High-speed, high-volume manufacturing and packaging equipment• Enterprise resource planning applications (i.e. SAP)• IT network & infrastructure• Quality Systems Software (CAPA / NCs; pharmacovigilance; eDMS; eLMS; etc.)• Mobile applications• Laboratory : information systems and equipment / computerized analytical instruments• Product improvements, material changes, vendor changes
• Contact information:• Raul Soto [email protected]
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http://camstar.industrysoftware.automation.siemens.com/user-groups/manufacturing-star-awards/#Johnson-Johnson
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OUTLINE
• Introduction• What is an MES
• Benefits
• ANSI / ISA – 95
• eDHR
• Scope: • What should be included in the
Validation project
• SDLC Approach• Description and deliverables
• Validation Deliverables• Planning and Strategy
• Requirements, Design, Trace Matrix
• Testing
• Reports, Procedures, and Governance
• Interfaces
• Going Live• Governance
• Hypercare
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INTRODUCTION
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WHAT IS AN MES
• Manufacturing Execution System• Takes in vast quantities of data coming from the PLCs
and SCADA/HMI systems• Converts that into useful information about production
ops• Scheduling• Materials handling• Quality samples
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ERP MES CONTROLS
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ANSI / ISA – 95 CONTROL HIERARCHY LEVELS
• Level 0: Physical production process
• Level 1: Sensing/manipulation of production process
• Level 2: Monitoring, supervisory control and automated control of production process (i.e. SCADA HMI systems)
• Level 3: Workflow / recipe control to produce desired products, maintain records and optimize production process. Timeframe: shifts, hours, minutes, seconds (i.e. MES, LIMS)
• Level 4: Establish basic plant schedule – production, material use, delivery, shipping. Timeframe: month, weeks, days, shifts (i.e. ERP)
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ANSI / ISA – 95 CONTROL HIERARCHY LEVELS
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BENEFITS OF MES
• Provide complete history of manufactured lots/ batches/ units
• Electronic Device History Record / Batch Record
• Electronic approvals and audit trails
• Full traceability of product to raw materials and manufacturing process parameters at every stage
• Reduce use of paper
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BENEFITS OF MES
• MES system is not just a piece of fancy technology
• The BUSINESS VALUE of an MES comes from the integration of data from multiple information sources: production data, quality data, business data, controls data, etc.
• Materials consumed, equipment used, parametric data, exceptions, date / time stamps
• Enforces as-designed process
• Ensures the right procedures, operators, equipment materials are used
• Enforces right sequence of operations
• Can track equipment usage and communicate with eCMMS
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EDHR
• eDHR: Electronic Device History Records
• paperless, electronic systems within MES
• enforce production processes
• capture all information associated with as-built production records.
• provides the error-proofing and real-time visibility necessary to produce consistent product quality each and every time.
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EDHR
• If product quality issues arise, eDHR can be used to contain suspect product, either in process or in the field, to take action to address the issue.
• The electronic records stored in eDHR yields information that can also help MD&D companies optimize production processes.
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SCOPE : WHAT SHOULD BE INCLUDED INTHE VALIDATION PROJECT
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M A N U F A C T U R I N G E X E C U T I O N S Y S T E M S
SOFTWARE VALIDATION
• validation, software. (NBS) Determination of the correctness of the final program or software produced from a development project with respect to the user needs and requirements. Validation is usually accomplished by verifying each stage of the software development life cycle. See: verification, software.
• Source: FDA Glossary of Computer System Software Development Terminology http://www.fda.gov/iceci/inspections/inspectionguides/ucm074875.htm
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SCOPE: SOFTWARE
• MES Application• Workflows
• Databases / Data warehouse • (i.e. Oracle)
• Middleware • (i.e. Archestra)
• Interfaces • (more on this later!)
• ETL tools• SQL scripts
• Reporting tools not part of the application • Reports created with tools like
Tableau, Cognos, BusinessObjects
• Other ancillary / support software
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SCOPE: HARDWARE
• Servers (for all environments)
• Sandbox / Development / QA-Test /
Staging / Production
• Scanners
• Printers
• Bar code readers
• RFID systems
• others
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SCOPE
• One or multiple sites?
• One or multiple manufacturing suites / lines (within each site)?
• Are you also decommissioning a legacy MES system?
• Data migration and /or archival
• GAMP 5: COTS vs Configuration vs Customization
• Medical Devices : eDHR • 21 CFR 820.184 - DEVICE HISTORY RECORD
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SCOPE
• Define your project scope early on, document all changes
• Map your AS-IS business process workflows (pre-MES), vs your TO-BE
• Include in scope any configuration and/or customizations required (i.e. reports, interfaces)
• Recommendation: Minimize custom-coding, maximize the use of configuration alternatives provided by software.
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PROJECT PLANNING
• Involve key stakeholders and end users from the start
• Testing, validation, user training and documentation require time and resources. Make sure you factor that into your project scope from the start.
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SDLC APPROACH
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M A N U F A C T U R I N G E X E C U T I O N S Y S T E M S
WHAT IS AN SDLC
• SDLC : Systems Development Life Cycle
• Series of steps / phases that provide a model for development and lifecycle management of an application or piece of software.
• Software validation is NOT a one-shot deal.
• Validated software and its documentation require continuousupdates and improvements for the life of the system
• End-of-life has to be managed• Data migration or archival• Hardware decommissioning
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SDLC APPROACH
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TYPICAL VALIDATION DELIVERABLES
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Validation Plan
Assessments
Requirements
Design
Development
SAT / FAT
IQ
OQ / System Testing
PQ / UAT
Traceability Matrix
Procedures
Validation Report
PURCHASING REQUIREMENTS
• NOT the same as your validation requirements
• Develop high level requirements to be used as part of the purchasing decision
• Vendor assessment should include compliance with these requirements
• Make sure you have a good idea of how much configuration and/or customization is needed to meet your main requirements• MINIMIZE the amount of customization / custom code
• These requirements will also be the basis for FAT / SAT
• SLA : Service Level Agreement
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DEVELOPMENT / CONFIGURATION
• Development testing occurs before validation• COTS functionality + configuration
• Vendor or hired consultants
• Unit testing, test configuration, integration testing
• If custom coding is required, development testing should be more comprehensive
• Use bug tracking software (i.e. FogBugz, Redmine, Debbugs) to keep track of bug resolution
• Does not need to be formally documented, but IT HELPS
• Have Coding standards and follow them!
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VALIDATION DELIVERABLES
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TYPICAL LIST OF VALIDATION DELIVERABLES
• Assessments • (Safety, 21CFR Part 11, Risk, Compliance,
Vendor etc.)
• Validation Plan
• Requirements (URS, FRS)
• Design (DS, FDS, TDS, DDS)
• Traceability Matrix
• Testing protocols and scripts• Development *
• Integration *
• FAT / SAT *
• Installation
• OQ / PQ or System Testing / UAT
• Testing Reports
• Training
• Procedures• Operational
• Administration
• Change Control
• Validation Report
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* Do not fall strictly under validation
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ASSESSMENTS
• Vendor Assessment
• Compliance Assessment (i.e. GxP, SOX, etc.)• 21 CFR Part 11 ER/ES (especially on Medical Devices)
• GAMP category
• Information Security
• Safety / EHS
• Risk Analysis / FMEA
• others
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VALIDATION PLAN & REPORT
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VALIDATION PLAN
• This is where you establish WHAT needs to be validated, and HOW it will be validated.
• Get everyone’s buy-in and commitment to the Validation Plan from the beginning
• Update as needed, following your organization’s formal change control process for documentation
• Define clear expectations for all roles
• Definitions of deliverables, author and approvers for each
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VALIDATION PLAN
• System Overview
• Scope of Validation
• Roles and Responsibilities
• Assessments Required
• Validation Deliverables, author and approvers
• Validation and Testing Strategy
• Acceptance Criteria
• How to deal with• Testing defects and deviations
• changes in scope and strategy
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VALIDATION REPORT
• Final scope
• List of Actual Deliverables• Document Numbers
• Date of Completion
• any additions or deviations from planned
• Summary of testing results per protocol; any additions or deviations
• Summary of defects and discrepancies, and resolution status
• Statement declaring the validated state of the system
• Release to Production
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RESOURCES
• You will need resources from multiple disciplines (i.e. QA, IT, Engineering, Operations, technical writers, etc.)
• Plan which resources you need, when will you need them, and for how long
• This will help you budget for consultants, and borrow internal resources. “I need two validation resources, 25-30% of their time, during August and September” is a different conversation than “I need to borrow some of your people for the MES project”
• PM tools -such as MS Project- help
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REQUIREMENTS
• Types:
• User Requirements
• Functional Requirements
• Regulatory Requirements
• Performance Requirements
• Security Requirements
• Classify by type and criticality
• Low criticality : nice to have
• Medium criticality: important but not critical
• High criticality: must have
• All regulatory requirements should be classified as HIGH criticality
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• WHAT do you want your MES system to do?
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REQUIREMENTS
• Clear• Complete• Correct• Consistent• Concise• Prioritized
• Relevant• Feasible• Verifiable• Modifiable• Traceable• Unique
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Requirements should be
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REQUIREMENTS
Written definition of the MES software functions:
• Proposed Workflows and Use Cases
• How users will interact with the system
• Functions that the MES software will perform
• Expected system inputs and outputs
• Reports the system is expected to generate, contents
• Interfaces (user, external)
• Required alarms and checks
• Performance: data throughput, reliability, timing
• Coding standards
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REQUIREMENTS
• Required response times
• Intended operating environment (hardware platform, software operating system, middleware, database software, etc.)
• All ranges, limits, defaults, specific values that the MES software requires
• Mirroring & Replication of main and transactional databases
• Backup, restore, disaster recovery
• User Roles that need to be defined in the system
• Any safety-related specifications
• Part 11: Electronic Records & Signatures requirements
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REQUIREMENTS: UDI
Unique Device Identification
• US Initiative to assign a unique identifier to all medical devices
• Signed into law on 2007, mandatory since 2013 FDA Final Rule
• Label of a medical device must have a unique identifier
• Unique identifier should ID device through distribution and use
• Unique identifier must include lot / serial number
• Typical elements:• Graphics and symbols
• Regular and 2D barcodes
• Lot / batch / serial number, expiration date, date of manufacture
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DESIGN
• HOW does your MES as installed and configured, meet the Requirements?
• Design Specifications describe the actual software solution:
• Out-of-box / configured / custom-coded
• Address all requirements, individually or in groups
• Design documentation may include one or more of the following:
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Design Specification
Detailed Design Specification
Technical Design Specification
Database Design Specification
Software Design Specification
Hardware Design Specification
Architecture Design
Security Design
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DESIGN
Design documentation should include, at least:
• Actual workflows and use cases, as configured (or coded)
• System architecture
• Modules
• Screens
• Formulas, algorithms, and logic used
• Data structures, data flow diagrams
• Supporting software that is required for MES operation (i.e. Archestra)
• Hardware required
• Parameters that are measured or recorded
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DESIGN
• Definition of control and data variables, where used
• Messages: Errors, alarms, warnings
• User roles, as configured
• Physical security
• Information security
• Actual reports as configured
• Interfaces, as configured
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REQUIREMENTS TRACEABILITY MATRIX
• The RTM should enable us to trace:• From individual Requirements to their
specific Design Element(s) where the requirement is addressed
• From Design Elements to the specific Test Script(s) where they are being challenged.
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We should be able to trace back and forwardRequirement Design elements Testing
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REQUIREMENTS TRACEABILITY MATRIX
• Requirements => start RTM draft
• Design documents => update RTM draft
• Test scripts => finalize RTM
• Final RTM should be approved before the system is released for production
• RTM should be updated as part of system change control every time requirements, design, or test scripts are changed, added, removed.
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LIVING DOCUMENTS
• The following documents should be treated as “living documents” and maintained up to date throughout the life of the system
• Requirements • Design• Traceability Matrix• Risk Assessments (i.e. FMEA)
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TESTING50M A N U FA C T U R I N G E X E C U T I O N S Y S T E M S
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TESTING
• Protocols, Test Scripts, Reports
• Pre- and post- approved
• Consistency in roles pre- and post- approving is important• Minimum: System Owner, Business Process Owner, QA
• Avoid conflicts of interest: Approvers cannot execute, testers can’t approve
• Dependencies and order of testing must be clear, evident, obvious
• Enforce Good Documentation Practices (GDP)
• Enforce the use of standard templates
• Keep evidence (printouts, screenshots, labels, etc.)
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TESTING ENVIRONMENTS
• Development / Sandbox • For DEV testing• Qualification not required
• Test / Staging• For your formal validation (OQ, System Testing, UAT)• Qualified• Functionally equivalent to your PROD environment
• Production Environment• Live system• Performance testing• Qualified
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INSTALLATION QUALIFICATION
• Installation Qualification• Document / verify the correct installation and configuration of
all software and hardware components, as per the Design Specification
• List actual software components and objects installed: name, version, location
• List actual hardware installed: name, model, quantity, S/N, location
• Turn-key test to ensure the system is ready for OQ / System testing
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OPERATIONAL QUALIFICATION
Operational Qualification• Ensure system can perform under controlled conditions, non-
saleable product
• Document that system is installed and configured as per Design Specifications
• AND complies with requirements as per Requirements Specifications
• Testing will challenge all requirements, interfaces, reports, etc.
• Can test each subsystem individually
• Positive vs Negative testing
• Formal change control
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OPERATIONAL QUALIFICATION
• System Testing• Test and verify that the system as integrated is functionally
complete
• Challenge compliance with functional and non-functional specifications
• Integration of MES with interfaces
• You can test individual functionalities, then end-end process workflows
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OPERATIONAL QUALIFICATION
Risk-based testing:
1. COTS elements: • positive testing of all workflows, and alternate flows
2. Configured elements: • Positive testing• Negative testing• Boundary testing
3. Custom: • Same as Configured elements, PLUS
• Code reviews against coding standards
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OPERATIONAL QUALIFICATION
• Tests functional requirements, configuration, security, ER/ES, compliance• May include positive testing, negative testing, boundary testing, interface
testing
• Positive Testing:• Ensures that system performs as intended, using normally expected inputs
• Negative Testing:• Ensures that system doesn’t accept invalid inputs
• Boundary Testing:• Challenges that performance is as expected when specific variables are set
to their max / min values.• Interface Testing:
• Tests that system components can pass data correctly to one another
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PERFORMANCE QUALIFICATION
Performance Qualification / Production Qualification• Test that system is able to function under normal manufacturing
conditions
• End-to-End challenge of the complete process flow
• Normal mix of lots, products, operators, shifts, etc.
• Performance testing / load testing
• SOPs must be approved and effective
• Can use saleable product if company procedures allow for it
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PERFORMANCE QUALIFICATION
• User Acceptance Testing• Testing focused on user-related requirements
• Challenge that the MES system is capable of supporting your normal business process
• Test cases should address ease of use from the standpoint of operators, QC technicians, etc.
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PERFORMANCE QUALIFICATION
• Tests functional requirements, configuration, security, ER/ES, compliance• May include positive & negative testing, business process testing, end-to-end
testing, stress testing, performance testing
• Business Process Testing:• Verifies that the system works as intended following business process flows
• End – to – End Testing:• Verifies that the system is capable of supporting the intended process flows, from
beginning to end; ensure data integrity and that the correct data passes between components and interfaces.
• Performance Testing:• Verifies system stability, resource usage, and responsiveness under specific workloads.
• Stress Testing:• Tests system’s performance beyond the limits established in the specified requirements
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TESTING EXECUTION
• Ensure test sets and scripts are executed in correct order
• GDP (Good Documentation Practices) are IMPORTANT
• Include evidence: screenshots, printouts, labels, etc.
• Changes to approved protocols / test scripts must follow formal documentation management (version up, re-approve, etc)
• Coordinate execution dates / times with owners of systems MES interfaces with
• Follow process for handling testing defects / deviations
• If you execute PQ / UAT with real product, QA must provide disposition of such product
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TESTING TOOLS
• There are electronic testing tools that can be used in substitution of paper test scripts• Example: HP Applications Life Management (ALM), Valgenesys
• MUST validate these tools BEFORE you use them
• Pros: reduce GDP errors, standardize testing process, enforce use of correct templates, enforce approvers rules, manage test defects, can search for documents electronically
• Cons: administration, training, cost, less flexibility, maintenance, fixes / upgrades
• Tools become your official repository of validation documentation
• 21 CFR Part 11 full compliance may require additional wrap-around software solution
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PROJECT CHANGE MANAGEMENT
• You must have a formal change control process while in the project, not just after go-live.
• Design freeze date – enforce it!• Any design changes requested after this date => after Go Live
• Except for critical (regulatory, business) changes
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CHANGE CONTROL
• All changes should be assessed, documented, pre-approved, tested, post-approved
• Assessment
• Nature and scope of the change
• Risk assessment
• Documentation that needs to be updated (Requirements, Design, RTM, FMEA, etc.)
• Testing
• Functional tests
• Regression tests
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INTERFACES
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INTERFACES
• Do NOT underestimate interfaces, especially to LIMS and your ERP.
• ALL interfaces must be part of the validation effort
• Define and document all your interfaces at the Design stage
• What data passes MES External system
• Test your interfaces configuration in Development testing
• Test your interfaces functionality explicitly in OQ / System Testing
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SAMPLE INTERFACES DIAGRAM
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ERPERPGlobal
Planning
SCADA / HMI
PLCs
Raw Materials Tracking
Distribution Control
Change ControlLIMS
MES
Lot production quantityand status
Audit DataData
Lot Info
POSSIBLE INTERFACES
• ERP (i.e. SAP, JD Edwards)
• Master production schedule
• Lot quantity and status
• Bill of materials
• LIMS (i.e. Labware, NuGenesis)• QC Audit data
• Manufacturing lines, SCADA / HMI (i.e. Wonderware, RSView)• Manufacturing orders
• Bill of materials
• Lot data
• Raw Materials Tracking software• Data exchange of r.m. lots used
• Documentation eDMS(i.e. Documentum)• Change control and procedures data
• Product hold information
• Distribution Control system• QC release data
• Lot data
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GOING LIVE
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GOVERNANCE
• Procedures• System Administration
• Operation
• Change Control
• Maintenance
• Training
• Security and Access Control
• Configuration Management
• Backup / Restore / Disaster Recovery
• others
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GOVERNANCE
• “Hypercare”
• SLA with vendors
• Change Control
• Support structure
• Periodic Review (and revalidation)
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REFERENCES
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https://www.fda.gov/RegulatoryInformation/Guidances/ucm085281.htm
REFERENCES
• http://ispe.org/gamp-good-practice-guide/manufacturing-execution-systems
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REFERENCES
• General Principles of Software Validation; Final Guidance for Industry and FDA Staff, Jan 11 2002• http://www.fda.gov/downloads/RegulatoryInformation/Guidances/ucm126955.pdf
• ISPE GAMP5 Guide: Manufacturing Execution Systems• http://ispe.org/gamp-good-practice-guide/manufacturing-execution-systems
• Understanding Manufacturing Execution Systems (MES)• http://www.freedomcorp.com/solutions/qad/White%20Papers/MES%20White%20Paper.pdf
• Unique Device Identification (UDI)• http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/UniqueDeviceIdentification/
• http://www.labelingnews.com/downloads/UDI_eBook.pdf
• Global Unique Device Identification Database (GUDID) Guidance for Industry and FDA Staff, June 27 2014• http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM369
248.pdf
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REFERENCES
• US 21 CFR 820 Quality System Regulation• http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=820
• US 21 CFR 11 Electronic Records and Signatures• http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=11&showFR=1
• Annex 11 Computerised Systems. Jan 2011 updateEudraLex, Rules Governing Medicinal Products in the European UnionVol. 4 Good Manufacturing Practice, Medicinal Products for Human and Veterinary Use
• http://ec.europa.eu/health/files/eudralex/vol-4/annex11_01-2011_en.pdf
• ISO 13485 Medical devices -- Quality management systems -- Requirements for regulatory purposes• http://www.iso.org/iso/iso_catalogue/catalogue_tc/catalogue_detail.htm?csnumber=36786
• ANSI/ISA 95 and ANSI/ISA 88 Standards• https://www.isa.org/standards-and-publications/isa-standards/find-isa-standards-in-numerical-order/
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QUESTIONS
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