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Pharmaceutical Regulatory and Compliance Congress and Best Practices Forum 21 CFR Part 11 Considerations November 14, 20

Pharmaceutical Regulatory and Compliance Congress and Best Practices Forum 21 CFR Part 11 Considerations November 14, 2002. Overview. 21 CFR Part 11 Introduction Panel Discussion Questions. 21 CFR Part 11 – What is it?. Self Imposed

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Pharmaceutical Regulatory and Compliance Congress and Best Practices Forum 21 CFR Part 11 Considerations November 14, 20

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  1. Pharmaceutical Regulatory and Compliance Congress and Best Practices Forum • 21 CFR Part 11 Considerations • November 14, 2002

  2. Overview • 21 CFR Part 11 Introduction • Panel Discussion • Questions

  3. 21 CFR Part 11 – What is it? • Self Imposed • Controls required to satisfy the FDA that electronic records and signatures and the legally binding equivalent to paper based records and signatures • The regulation was published on March 20, 1997 with an effective date of August 20, 1997 • Record requirements are mandatory • Signature components are not currently mandatory • File Cabinet Analogy

  4. Requirements • Electronic Records: • Validation • Audit Trails • Information Security • Archiving • Backup and Recovery • Sequencing Controls • Device Checks • Ability to Export Data in Human Readable Form • Training • Document Control • Electronic Signatures (ID/Password/Reason) • Password Controls • Linking of Signatures to Records • Legally Binding

  5. 21 CFR Part 11 Challenges • Availability of Commercial Solutions that are Part 11 Capable • Total compliance requires a combination of • Technical controls • Procedural controls • And, sometimes “Interim” controls • “Baseline state” of the system needs to be identified • Systematic approach to addressing gaps • Timelines and the cost of remediation

  6. Panel Discussion • Compliance Costs and Timelines • How much should be spent to address remediation over what period of time? • Compliance Risk vs. Cost vs. Other Business Priorities • What timeframes are accepted by the FDA? • Convincing management of the risk and priority • Changing FDA GMP and Part 11 perspective • Inspection/Audit Focus Areas • Individual systems • 21 CFR Part 11 program • IT Service Providers • Security • Disaster Recovery • Validation • Other

  7. Panel Discussion • Remediation Challenges: • Network Qualification • Consistent Validation Methodology/Approach • Security Program • Standard Operating Procedures • Coordination Across Business Units • Systems that are not “owned” by IT

  8. Questions and Discussion

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