Validation Master Plan Suggestions$

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SoftwareCPR suggestions for a validation or Part 11 master plan are that it be a high-level plan not providing detailed document or protocol formats. Generally it is best if a master plan is a transient document.  It gets constructed for a specific need (e.g., constructing a new facility, addressing a systemic issue or new regulatory requirement).  Once the activities defined in the . . .

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CSV Training Course

Learn FDA expectations for software validation for computer systems, quality system software, manufacturing and production process software, and engineering tools. Email training@softwarecpr.com for more info.

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