I’m currently working at a medical device client on manufacturing process validation. There are several consultants on site–all for the sole purpose of process validation. The project scope is limited but should it be?
There are issues with this limited scope and approach. Process validation is just one piece of the medical device puzzle. In order to fully remediate issues with process validation, it may be necessary to revisit quality system procedures, design controls, change management, CAPA, and a host of other areas.
If a company has issues with process validation, chances are other areas have deficiencies as well. Medical device OEMs should seek outsourcing partners that can provide a comprehensive suite of services–not just process validation. “The Proof is in the Pudding” article from Medical Product Outsourcing describes some needs OEMs have regarding process validation and ways to tackle these issues with outsourcing partners.