Drug manufacturers: Be careful what you wish for.
For years, drugmakers have urged the FDA to revisit 21 CFR Part 11, which governs electronic records.
Now the FDA has done so — and the industry faces new compliance burdens.
The FDA has tapped two of its most knowledgeable and assertive Part 11 experts to implement a program of “tag-along” Part 11 inspections through CDER.
Soon the agency will begin sending Part 11 specialists along on selected regular GMP, GLP and GCP inspections, to focus on electronic records regulation compliance.
Don’t wait until it’s too late. Now — before the inspector knocks — is the time to learn what the FDA is looking for.
The staff of FDAnews has been working overtime, readying a manual to guide you. It’s called The FDA's New Focus on Part 11: How to Prepare for the FDA's Tough, New Electronic Records Inspections.
These Part 11 inspections will confront you with a new level of scrutiny. For example, do you know:
Don’t risk warning letters, or worse. Order copies now for everyone in your organization with GMP, GLP and GCP responsibilities.
The FDA's New Focus on Part 11: How to Prepare for the FDA's Tough, New Electronic Records Inspections is available in print or PDF format for $377.
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