Life science validation projects –– particularly those in heavily regulated industries like medical device and pharmaceutical manufacturing –– often require a multi-disciplinary team of professionals sourced from internal functional areas as well as outside resourcing firms capable of filling internal gaps and bringing firsthand experience and specialized expertise to bear.

The practice of using multi-disciplinary teams to support Quality System activities including the Qualification and/or Validation of new or modified facilities, systems and processes has become a cGMP expectation of the FDA as well as many other regulatory agencies in ICH markets.

Regardless of the specific type of validation work being done, quality outcomes are increasingly reliant on creating these cross-functional teams that are built and managed in a way that recognizes the abilities, incentives, and limitations of each stakeholder and points them toward the same objective.

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