Out of Specification Posts

Insights on Out of Specification Management and Compliance

Insights on Out of Specification Management and Compliance

Kevin Lee, Industry Solutions Consultant, Pilgrim Quality Solutions

This week, Pilgrim is officially introducing a new fully-validated solution called SmartSolve® Out Of Specification Management. Managing out-of-specification (OOS) results is a critical area of focus among pharmaceutical and combination product manufacturers. To help you understand the critical nature of this operational element, we’ve created this Q&A about compliance facts and insights on data integrity, and commonly used acronyms that relate to OOS. Let’s begin with the basics. (more…)