Annex 11
Annex 11 is a guideline from the European Medicines Agency (EMA). It explains how pharmaceutical and biotech companies should use computer systems. It ensures that electronic records, data, and automated processes follow strict rules. This keeps them safe, accurate, and legal.
Think of Annex 11 as a rulebook for digital systems in life sciences. It covers things like software testing, data security, system access, and tracking changes. If a company uses technology for regulatory or manufacturing data, Annex 11 makes sure it's done correctly, safely, and openly.
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