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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:
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:
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