# Presentation: 721675

## Comments Presentation for Part11 FDA Public MeetingDocket # 2004N-0133

- _Venue and Date:_
- 429 L'Enfant Plaza, SWWashington, DC  20594
- June 11, 2004

## Presentation by:Sanjeev KumarManager, Computer System Validation ComplianceApotex Inc.150 Signet DriveWeston, Ontario M9L 1T9Telephone: (416) 675-8421

## Discussion Points

- Comments on:
- Narrow interpretation of Part11
- Legacy Systems
- Should Part11 address Record Conversion
- Risk Based Approaches
- Audit Trail requirements
- Role of QA

## Narrow Interpretation of Part11

- Comments:
- Has provided more flexibility;
- Has encouraged innovation;
- Makes sense as validation extent can be derivative of the Risk Assessment;
- General industry can utilize latest PAT driven technologies for better process development and for BETTER PRODUCT;

## Narrow Interpretation of Part11

- Comments:
- Legacy systems being out of scope makes remediation efforts less daunting and less money intensive;
- Risk assessment on the e-records level has made records archiving more sensible and logical.
- THANKS TO THE AGENCY FOR ALL THIS

## Legacy Systems

- Comments:
- _SYSTEM_
- More clarity required on what FDA expects on Legacy Systems that have been upgraded;
- What level of system upgrade transitions Legacy to non-Legacy Systems;
- What Remediation Efforts are expected from the industry for non-Legacy systems;
- _RECORDS_
- Records archiving of the e-records generated by Legacy systems that are still in use.

## Should Part11 Address Records Conversion

- Comments:
- E-Records
- _Short Answer is:_
- YES
- _And the Long one is :_
- Following should be addressed as part of above subject:
- What data should be archived or converted ; Raw or Processed;
- If RAW DATA then does META DATA also needs to be there;
- Does FDA expect industry to maintain obsolete technology to convert Raw data into processed results at the time of inspection / Audit.
- Agency should recommend the risk assessment model for determining the rationale for records storage.

## Should Part11 Address Records Conversion

- Comments:
- Paper Records
- FDA should provide guidance on converting paper records in to e-records; examples:
- Qualification protocols can be scanned and pdf’ed for long time storage; will these records be acceptable to FDA during the audits as original paper documents will not be available.

## RISK ASSESSMENT

- Comments:
- Agency should provide examples of risk assessment models thus sharing their expectations;
- Clear direction on the basis of Risk Assessment that is; risk assessment should be based on system complexity or system’s risk to the business. A very simple system can be of very high risk value to GxP business.

## Audit Trail Requirements

- Comments:
- The new rule should clearly indicate for what specific actions audit trail is mandatory for instance:
- Is audit trail required for system’s administrator’s actions such as user profile administration;
- Or just the operator/ user level actions should be logged;
-  If possible is procedurilzed audit trail log (may be manual) accepted;

## Audit Trail Requirements

- Comments:
- Audit trail requirements should include safeguards designed and implemented to:
- Deter unauthorized records creation;
- Prevent unauthorized modifications of records;
- Prevent deletion of unauthorized records;
- Agency should clearly state their expectation on:
- Is it mandatory for the system to have ability to generate audit trails. (Computer generated)
- Can agency clarify the difference between the predicate rule requirement of Audit Trail and 11.10(e) requirements.

## Role of QA

- Comments:
- FDA through Part11 or predicate rules should provide direction on:
- Does FDA expect QA’s role as providing:
- Independent meaningful assessment of qualification work;
- Defend systems during audits;
- What training level, qualifications or experience should a QA have to :
- Provide meaningful qualification document review;
- Conduct vendor audits;
- Defend systems validation;

## Comments Presentation for Part11 FDA Public MeetingDocket # 2004N-0133

- _Thanks for the opportunity._
- _Any Questions_