Process Analytical Technology (PAT)

Existing validated measurements correlate poorly with process performance. Single variable measurements are used to infer compliance of complex dynamic systems. Products are currently manufactured according to fixed process conditions that were determined during development and confirmed during validation. Release is based on physical and chemical testing performed after manufacture, not during.

Process Analytical Technology (PAT) is a system for designing, analyzing, and controlling manufacturing processes based on an understanding of the principles involved and identifying the variables that affect product quality. PAT is a methodology consistent with the FDA's belief that quality is not a question of testing but one of design. Quality is designed into products, not tested into them.

How Patni Can Help
Patni's risk-based approach to the implementation and validation of computer systems used to gather and analyze process data allows our clients to concentrate on understanding the underlying physical and chemical processes involved in the manufacturing process. Patni's experience in gathering and integrating data from multiple disparate sources helps our clients to easily use multiple data sources with various process control systems. Our validation and auditing offerings help assure that the systems and vendors chosen meet the needs of our customers.

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