2004N-0133 - Part 11 Public Meeting; June 11, 2004
FDA Comment Number : EC6
Submitter : Mr. Sanjeev Kumar Date & Time: 05/14/2004 06:05:39
Organization : Apotex Inc.
Drug Industry
Category :
Issue Areas/Comments
Abstract of the presentation for FDA?s public meeting on Part11 on June 11,2004

Topic: Legacy Systems
Legacy Systems are systems that are in use prior to Part11 introduction i.e. August 1997. These systems have undergone various updates.

1. With the fast evolving technology, the legacy systems have undergone various changes and some of the systems have totally changed with some only partially. How much modification a system has to undergo to move from LEGACY status to Non-LEGACY status.
As we all know there are lot of differences in the validation approaches that are required for both categories of the systems.
2. From August 1997 till few years back, because of vast altitude in Part11 interpretation there have been lot of systems that were introduced and could not follow Part11 requirements due to the stated reason. What are the expectations of FDA in terms of their (those system?s) compliance to Part11?
It is worth mentioning here that remediation effort will entail lot of investments in terms of time and other resources and what kind of time frame FDA will allow for remediation effort?

Enforcement discretion in this regard from FDA will allow industries to continue to focus and adopt new technologies.

Topic: Should Part11 address record conversion?

But before that FDA should clearly indicate what records they want industry to retain. Only the RAW DATA with complete processing capability or PROCESSED DATA. The ambiguity comes from predicate rules that state that raw data should be available.
If raw data is to retained then the Hardware and software required to process that data will also required to be retained, which entails very high data maintenance costs.

Topic: Risk Based Approaches
Risk assessments should be based on:
? System level and records level
? System?s impact on company?s GxP systems;
? System?s complexity that will decide whether the system requires multiple security provisions;
? System developer?s quality systems.