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Annex 11 and 21 CFR Part 11 and Comparisons for International Compliance

What the Revised European Union’s Annex 11 Means to Life Science Companies

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About This Document

What does this mean to life science companies and related suppliers currently in the EU market? First, Annex 11 is not a legal requirement but a guidance that applies to companies that manufacture or sell human and veterinary medicinal products in the 27 states belonging to the European Union.