Pharmaceutical Regulatory and Compliance Congress and Best Practices

Pharmaceutical Regulatory and Compliance Congress and Best Practices

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

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 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 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 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 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 Questions and Discussion

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