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

Comments Presentation for Part11 FDA Public Meeting Docket # 2004N-0133. Venue and Date: 429 L'Enfant Plaza, SW Washington, DC  20594 June 11, 2004.

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

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  1. Comments PresentationforPart11 FDA Public MeetingDocket # 2004N-0133 Venue and Date: 429 L'Enfant Plaza, SWWashington, DC  20594 June 11, 2004

  2. Presentation by:Sanjeev KumarManager, Computer System Validation ComplianceApotex Inc.150 Signet DriveWeston, Ontario M9L 1T9Telephone: (416) 675-8421

  3. Discussion Points Comments on: • Narrow interpretation of Part11 • Legacy Systems • Should Part11 address Record Conversion • Risk Based Approaches • Audit Trail requirements • Role of QA

  4. 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;

  5. 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

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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;

  11. 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.

  12. 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;

  13. Comments PresentationforPart11 FDA Public MeetingDocket # 2004N-0133 Thanks for the opportunity. Any Questions

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