CAPA Overload And Other Perils To Avoid On Your Compliance Journey

By James Jardine

There are countless obstacles to compliance that arise as a pharmaceutical company undertakes its regulatory journey. Data control failures. Delays in getting signature approvals. Training oversights that lead to unforeseen quality events. The list seems endless.

One particular hazard poses a significant challenge to pharma companies that are striving to maintain compliance and get high-quality products to market quickly: corrective action/preventive action (CAPA) overload. Too many pharma companies get bogged down with disorganized and time-consuming investigations into the causes of quality events like deviations and nonconformances. “Death by CAPA” is a common problem companies bring upon themselves when they push nearly every quality issue through a CAPA process rather than taking a more strategic approach.

Learn how to develop a smarter pharma CAPA management system.