Investigations and Corrective and
Preventive Action (CAPA)

The need for products manufactured by the pharmaceutical, biotech, and medical device companies to consistently perform as intended is a major area of focus within the industry. The costs associated with product recalls are staggering, which make a company's ability to quickly identify, assess, and correct issues that can impact product quality a critically important component of its manufacturing operations.

The FDA requires manufacturers of pharmaceutical, biological and medical devices to identify, investigate and report on deficient or failed product. Implementing an Investigation or CAPA system not only helps companies fulfill their regulatory obligations, but also helps prevent new problems from arising and known problems from re-occurring.

How Patni Can Help
The main focus of Patni qualified personnel in the investigations and CAPA area is to support industry to achieve the best results in the investigation and CAPA fields, and to maintain compliance with FDA regulations.

Patni Focus Areas