(Aegis Corp.: Lafayette, Colorado) -- Recent deployment of manufacturing process intelligence software “Discoverant,” from Aegis Analytical Corp., enables life science manufacturers to apply the updated principles and approaches for process validation outlined in the United States Food and Drug Administration's (FDA) “Guidance for Industry Process Validation: General Principles and Practices,” draft published in November 2008.

The FDA published updated draft guidance on process validation, which it defines as “the collection and evaluation of data, from the process design stage throughout production, which establishes scientific evidence that a process is capable of consistently delivering quality products.” To leverage knowledge and understanding as the basis for establishing an approach to control that is appropriate for the manufacturing process, the FDA guidance recommends that manufacturers:

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