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Comments Presentation for
Part11 FDA Public MeetingDocket # 2004N-0133
Venue and Date:
429 L'Enfant Plaza, SWWashington, DC 20594
June 11, 2004
Presentation by:
Sanjeev KumarManager, Computer System Validation Compliance
Apotex Inc.150 Signet Drive
Weston, Ontario M9L 1T9Telephone: (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 MeetingDocket # 2004N-0133
Thanks for the opportunity.
Any Questions