The System Development Lifecycle (SDLC) and Computer System Validation (CSV) in Drug Manufacturing | CPhI North America

 

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The System Development Lifecycle (SDLC) and Computer System Validation (CSV) in Drug Manufacturing

Tony Pezzolo (Practice Manager, Compliance and Validation Services / Global CSV SME, PerkinElmer)

Location: E353c

Date: Wednesday, May 1

Time: 2:15pm - 3:00pm

Track: Drug Manufacturing

Vault Recording: TBD

Validation of computerized instruments is not a one-time activity but viewed and approached as a lifecycle, including commissioning, change control/maintenance, and retirement. Computer System validation is an integral part of this process. As the regulations on validation grow in complexity, their interpretation and response is not uniform in the industry. As such, many SDLC & CSV policies are over-engineered, inefficient, and as a result, the time and cost of commissioning and maintaining new equipment can grow exorbitant. Best practices need to be deployed that allow for flexibility and streamlining. In other words, compliance is no longer enough – every company needs an SDLC program that allows the business to move quicker and reduce instrument down time.