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FDA Expectations for Validation of Computer Systems. Harold Blackwood Investigator (Automated Systems Specialist) FDA Atlanta District [email protected] Validation.

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FDA Expectations for Validation of Computer Systems

Harold Blackwood

Investigator (Automated Systems Specialist)

FDA Atlanta District

[email protected]

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  • Establishing DOCUMENTED EVIDENCE which provides a high degree of assurance that a specific process will consistently produce a product meeting its PREDETERMINED SPECIFICATIONS and quality attributes.

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  • Must have knowledge that the process used to make the product, be it software or hardware, is going to produce a product that is consistent from lot to lot, unit to unit.

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Software Validation

  • Establishing by objective evidence that the software conforms with user needs and intended uses of those functions that have been allocated to the software.

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Software Verification

  • Confirmation that the output of a particular phase of development meets all of the input requirements for that phase

  • Verification Activities

    • Testing

    • Walk throughs

    • Code and document inspection

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Life Cycle Activities

  • Risk Management/Hazard Analysis

  • Requirements Analysis and Specification

  • Design

  • Implementation

  • Integration

  • Validation

  • Maintenance

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FDA Inspection

  • What documentation do you have for the software?

    • Requirement Specifications

    • Design

    • Test plans and results

    • Validation Plans and Reports

    • Hazard Analysis

    • Criticality Analysis

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Requirement Specifications

  • Complete

  • Correct

  • Consistent

  • Current

  • Verifiable

  • Traceable

  • Annotated

  • Unambiguous

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  • High Level Diagrams

  • Interface definition

  • Critical decision points

  • Hazard Analysis

  • Reports Design

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Test Plans and Results

  • Matrix to map to Requirements

  • Rationale for testing Program

  • Specific so that they are repeatable

  • Test thoroughness based on criticality or hazard analysis

  • Expected results stated

  • Complete reporting of actual results

  • Reviewed and signed off on

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Validation Plans and Reports

  • Review of all documentation

  • Any deviations reviewed and categorized

  • Critical areas are fixed

  • Minor areas, SOPs put in place

  • User manual complete and correct

  • Signed off as released

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Important Elements of Validation Program:

  • Training of personnel on software validation and guidelines on what software products have to be validated.

  • Defined internal procedures for conducting the validation program, including standards for writing specifications, guidelines for validating process software, and forms for identifying and tracking safety hazards.

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Important Elements of Validation Program:

  • Training/requiring programmers to retain their testing documentation.

  • Allocation of resources to conduct the validation program

  • Development of a validation program that focus resources on critical areas.

  • Use of documentation templates, measurement tools and checklists where appropriate

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Important Elements of Validation Program:

  • Communication between programmers and the QA personnel and QA functions that contribute to the development efforts.

  • Application of software validation and QA techniques early in the software development process.

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Software Scenarios

  • Off-The-Shelf Software

  • Custom Designed Software

  • Developed In-House

  • Maintained Software

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Off-The-Shelf Software

  • Word processing

  • Spreadsheet / Database

  • Information Management

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Off-The-Shelf Software

  • Word processing

    • Meets Requirements

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Off-The-Shelf Software

  • Spreadsheet / Database

    • Meets Requirements

    • Key Functions perform properly

    • Validation of created Formulas, Scripts, and Routines

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Off-The-Shelf Software

  • Information Management

    • Meets Requirements

    • Hardware installed properly

    • Key Functions perform properly

    • Integration between software and hardware

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Custom Designed

  • Requirement Specification

  • Key Functions perform properly

  • Software Development Documents and Validation done by Vendor

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Written In-House

  • Complete Software Development Documentation

  • Validation

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Maintained Software

  • Software Development Documentation for changes to software

  • Validation of Changes

  • Integration to rest of software program.