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