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Pharma Manufacturing App: Validation Documentation Support


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We want your feedback on this proposed Pharma Manufacturing App. How would this App be impactful for you? What comments do you have on the requirements? Do you have anything to add?

Objectives: Create documentation to support software validation processes
Value: Lead to a faster Go Live via pre-defined validation documentation
High Level Requirements:

  • Identify use cases that require additional software validation documentation to support Go Live.
  • Identify list of documents that can be prepared generically to support software validation processes (e.g. functional specs, design specs, test plans, and installation protocols for specific use cases).
  • For each document, identify topics and content required as per quality assurance\management policies (e.g. access control, ERES, and analytic data models inputs and outputs).

This is the definition of an App: Spotfire App.pdf

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