1. The IT Quality Assurance FDA Validation Specialists Phone: 877-MGD-TEST (877-643-8378) n n Email: gretchen@mgdservices.com n n Web Site: http://mgdservices.com Running with Technology MGD Services, Inc.

2. FDA Validation Overview All systems that require compliance with FDA guidelines must go through the validation process which ensures compliance.

3. Validation Task List n Validation Master Plan n Validation Library n SOP’s n Compliance Reviews n Traceability Matrix n IQ/OQ & PQ n 21 CFR Part 11 n Validation Summary Report

4. Validation Documentation All software systems that are developed or used for FDA submissions or systems that are used with medical devises are subject to review by the FDA. All phases of the Project Life Cycle are required to maintain FDA validation documents

5. Overall Design Documentation The documentation necessary to support the overall design of the system to be validated.

6. Project Management Documentation The management team for the project will be required to maintain project level documentation as well as to establish regularly scheduled project meetings.

7. Hardware Documentation All of the hardware required to support the software systems will be required to maintain installation and operational documentation.

8. Database Documentation The database that supports the applications must maintain documentation that supports the design and capabilities of the database.

9. Reports Documentation The reports that are generated by the system users require supporting documentation on the setup and capabilities of the reports.

10. Quality Assurance Documentation The largest area that requires good solid documentation is Quality Assurance. Before the system can be validated the system must be tested and all supporting test documentation must be maintained.

11. Change Control Documentation The change control for the system under development is critical. All changes must be documented and all supporting documentation must be maintained in the validation library.

12. 21 CFR Part 11 Documentation This aspect of FDA validation has moved to the forefront of the development process. Keeping the documentation necessary to support electronic signatures is critical.

13. Validation Auditor H Develops FDA validation guidelines H Writes Validation Plan H Performs compliance reviews H Assists all project team members in establishing compliance H H Performs all other compliance activities necessary

14. In Closing... Ensuring FDA validation and compliance for our clients development projects enables the project to pass any FDA validation audit, thereby ensuring the system is moved into production on time. MGD Services, Inc. P: 877-MGD-TEST Web: mgdservices.com E-Mail: gretchen@mgdservices.com