1. FDA Part 11 Public Meeting Part 11 Simplification, and a Return to the Original Intent Presented By: Martin Browning, EduQuest, Inc. Info@EduQuest.Net

2. © 2004 EduQuest, Inc. Part 11 Simplification and a Return to the Original Intent Issues –The reality of the current problem –The simplicity of the original intent –The problem areas –The path forward – simplification

3. © 2004 EduQuest, Inc. The Reality of the Current Problem Management taken by surprise Realization that Part 11 is not a “Quality” problem A lack of understanding of “validation” A lack of understanding of the “predicate” regulations The quantity of work

4. © 2004 EduQuest, Inc. The Reality of the Current Problem “Upper management feels…” “We have no consistent …” “Validation is impossible …” “We want to comply …” “We can’t write software according to this …”

5. © 2004 EduQuest, Inc. The Simplicity of the Original Intent To encourage and facilitate the adoption of technological improvements without a loss in data integrity To provide for no less integrity for electronic data and electronic signatures than for paper based data and signatures To accomplish the above within the existing regulatory framework

6. © 2004 EduQuest, Inc. The Simplicity of the Original Intent How –Rely on existing FDA recordkeeping regulations –Borrow from industries already involved with electronic data integrity Financial Legal –Apply “common sense” (sometimes referred to as a “risk-based” approach)

7. © 2004 EduQuest, Inc. The Problem Areas Validation – poorly understood, poorly defined to the software industry Documents vs. records – no distinction made Audit trails – not clearly defined as data change documentation (as in the financial industry) Grandfathering of legacy systems – not allowed

8. © 2004 EduQuest, Inc. The Problem Areas Archiving – new requirements “interpreted” into the regulation Time stamps – a classic “red herring” issue Electronic copies – more new requirements “interpreted” into the regulation A glossary – all of the above

9. © 2004 EduQuest, Inc. The Path Forward – Simplification Define computerized system validation as the documented use of good software development practice applied according to intended use (i.e., the risk) of the system Distinguish between documents and records and the way they are created and maintained

10. © 2004 EduQuest, Inc. The Path Forward – Simplification Point out that audit trails (data change records) are required by predicate regulations Grandfather systems in use prior to 8/20/97 –As long as the predicate regulations are met and until they are retired/replaced

11. © 2004 EduQuest, Inc. The Path Forward – Simplification Archiving – clarify that the purpose and utility of archived electronic records are the same as for archived paper records –Documenting what happened, and not replaying, redoing, or reprocessing the event Apply common sense to issues such as time stamps, password use, etc.

12. © 2004 EduQuest, Inc. The Path Forward – Simplification Electronic copies – –Stick with the concept that a copy is an exact copy, not a reinterpretation of data, not data modified into a “universal” format, not a different representation of the data –FDA will find the ability to use/interpret/analyze an exact copy of an electronic record just as it did for many years prior to Part 11 and it will have the benefit of being recognized as “evidence” without confusion or making industry validate conversion processes

13. © 2004 EduQuest, Inc. The Path Forward – Simplification There is no need to change the text of Part 11 –All of these issues can be dealt with by republishing the text of the regulation while simplifying the interpretation by making the interpretation match what was originally intended