SoftwareCPR Comments on Part 11 Glossary

SoftwareCPR submitted comments on the Glossary Guidance to suggest adding a series of definitions to help distinguish various types of electronic records. Different types require different approaches to compliance and validation. Having terms to describe these can help companies evaluating approaches and planning validation. By recognizing these distinctions FDA can also tailor their future guidance and enforcement to allow for these or similar distinctions. The official record of the SoftwareCPR comments is at the link provided.

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