PDF Edition - Annex 11: How to Comply With the EU’s New Requirements for Computer Systems

May 2011
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Just when you think you’ve got the FDA’s Part 11 validation rules under control, the EU has issued its new Annex 11 requirements.

Now you’ve got to comply with rules for a staggering range of computer systems and processes — including many not addressed under Part 11.

Do you know exactly how Annex 11 differs from previous EU rules and from Part 11?  Will you be able to satisfy tough new audit trail and personnel requirements?  And what about your suppliers’ systems, procedures and networks: are they all compliant?

Here’s how to retool systems and rethink risk management, fast!

This management report from FDAnews provides drugmakers and suppliers with a thorough overview of the EU’s risk management approach.

With this concise source, you’ll learn how to work with the new Annex 11 requirements for computer-related procedures, such as:

  • Project and lifecycle management
  • Validation
  • Periodic evaluations and audit trails
  • Data integrity
  • Electronic signatures
  • Printouts

Buy now to hit the ground running in late June with practical know-how for complying with new requirements and meshing them with existing efforts, including:

  • How the new Annex 11 compares with Part 11 — and how Annex 11 compliance can help you sail through FDA inspections
  • How Annex 11 compares to previous EU rules — what has changed and what needs to change in your operations
  • What EU regulators now expect in terms of periodic validation and ID support of validated systems
  • Best practices for addressing Annex 11’s new personnel requirements
  • How to develop the kinds of audit trails now necessary to avoid sanctions
  • Special considerations for QPs in system requirements
  • And more

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