This content is only available to Premium and higher subscribers.  See our Subscribe page for information on subscriptions.

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 . . .

Thank you for your interest!  To view our Premium or Standards Navigator content, please click here to select the plan that best fits your needs.