Why Manual CQV Costs More Than You Think

By Saurabh Joshi, Director of Industry Solutions, ValGenesis

Commissioning, Qualification, and Validation (CQV) are essential pillars in the pharmaceutical and biotech manufacturing sectors. These processes ensure that facilities, equipment, and operations consistently adhere to stringent regulatory standards, which safeguard product quality and patient safety. While the concept of CQV might seem straightforward, its implementation often proves to be a complex, time-consuming, and resource-intensive challenge. Despite the critical importance of CQV, many organizations continue to rely on outdated, manual methods for documentation and coordination. This includes the use of paper forms, extensive spreadsheets, and numerous in-person sign-offs. At first glance, manual CQV processes might appear manageable, albeit somewhat laborious. However, beneath this seemingly familiar and routine approach lie significant hidden costs: delays, rework, overstretched personnel, and regulatory risks, among others.

Explore how a transition to automated and digital solutions can streamline operations, reduce risks, and enhance overall efficiency to ensure compliance and safeguard patient safety more effectively.