21 CFR Part 11: current status (2008)
A brief update on the status of US-FDA 21 CFR Part 11 was given at the recent launch of ISPE GAMP5. Based on the Guidance for Industry from 2003 (Scope and Applications) 21 CFR Part 11 has been reworded but is currently undergoing extensive reviews within FDA prior to any public review.
The date of the public review is still unknown and may not happen in 2008. In the meantime the best advice is to follow the final FDA guidance. Although a risk-based approach should be applied to electronic signatures and records, it is recommended to:
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Identify and analyze regulatory guidance documents and predicate rules requirements (e.g., submission of common technical specifications, GMP - 21 CFR Part 210/211, etc.).
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Analyze local laws regarding electronic and digital signatures that apply to you and your business areas.
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Check into consultant agencies that apply to you as well.
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Analyze existing or planned information technology (IT) infrastructure (e.g., like IT security standards).
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Create an overall roadmap for IT systems and signature definitions.
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Create necessary procedures and requirement documents.
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Verify the correct implementation and operation.
Part 11 controls to ensure requirements are met:
- Administrative Controls: Set policies, assign roles and responsibilities, operator and administrator training, ITIL implementation, auditing
- Procedural Controls: SOPs and Work Instructions for operation and administration, computer system validation, calibration, network qualification. awarness training
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Technical Controls:Computerized features like audit trail, backup mechanism, user management and security, electronic signatures and/or digital signatures to assist or enforce administrative and procedural controls
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