FDA Expectations for Validation of Computer Systems

1. FDA Expectations for Validation of Computer Systems Harold Blackwood Investigator (Automated Systems Specialist) FDA Atlanta District HBlackwo@ORA.FDA.GOV

2. Validation • 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.

3. Validation • 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.

4. 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.

5. 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

6. Life Cycle Activities • Risk Management/Hazard Analysis • Requirements Analysis and Specification • Design • Implementation • Integration • Validation • Maintenance

7. 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

8. Requirement Specifications • Complete • Correct • Consistent • Current • Verifiable • Traceable • Annotated • Unambiguous

9. Design • High Level Diagrams • Interface definition • Critical decision points • Hazard Analysis • Reports Design

10. 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

11. 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

12. 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.

13. 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

14. 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.

15. Software Scenarios • Off-The-Shelf Software • Custom Designed Software • Developed In-House • Maintained Software

16. Off-The-Shelf Software • Word processing • Spreadsheet / Database • Information Management

17. Off-The-Shelf Software • Word processing • Meets Requirements

18. Off-The-Shelf Software • Spreadsheet / Database • Meets Requirements • Key Functions perform properly • Validation of created Formulas, Scripts, and Routines

19. Off-The-Shelf Software • Information Management • Meets Requirements • Hardware installed properly • Key Functions perform properly • Integration between software and hardware

20. Custom Designed • Requirement Specification • Key Functions perform properly • Software Development Documents and Validation done by Vendor

21. Written In-House • Complete Software Development Documentation • Validation

22. Maintained Software • Software Development Documentation for changes to software • Validation of Changes • Integration to rest of software program.

23. Questions