Pilgrim Introduces OOS Management Software to Support Pharmaceutical Manufacturing

Pilgrim Quality Solutions announced the validated release of SmartSolve Out Of Specification (OOS) Management. Pilgrim’s out-of-specification software drives consistent OOS investigations and offers valuable reporting capabilities to identify areas for improvement in pharmaceutical laboratory and manufacturing processes.

The purpose of Out Of Specification Management (OOS) investigations is to identify the root cause of the lab result, correct the issue, and ensure all product that reaches market is to-specification and sound for patient use and public safety. Pharmaceutical and combination product manufacturers need an effective, consistent methodology to conduct laboratory and full-scale manufacturing investigations.

Pilgrim’s Out Of Specification Management software design mirrors FDA guidance on out-of-specification lab result investigations and provides tools to reduce risk. This includes the ability to create a corrective or preventive action (CAPA) only when the risk level dictates its need.

“Through our experience working directly with clients in the pharmaceutical industry, Pilgrim understands the importance of having a solution to facilitate a consistent, effective out-of-specification process,” said Kari Miller, Pilgrim Regulatory and Product Management leader. “SmartSolve Out Of Specification Management provides our clients with the tools and resources they need to implement a compliant OOS process, and to generate the proper level or levels of investigation, objective evidence, and trending needed to maintain compliance and be audit-ready.”

Pilgrim continues to enhance its SmartSolve suite to support the quality management processes key to Life Sciences organizations. The latest Out Of Specification Management software is a key step toward meeting the specific demands of enterprises within the pharmaceutical and combination product arenas.

In addition to supporting consistent investigations and reducing risk, the out-of-specification software helps drive continuous improvement in quality and manufacturing with robust reporting for root cause analysis and identifying trends over time, including out-of-trend (OOT) results.

Out Of Specification Management is an integrated part of SmartSolve, Pilgrim’s quality management suite of solutions. Integration across the platform ensures that related quality events, including CAPAs and deviations, are addressed through the consistent application of regulatory standards. This means the out-of-specification software facilitates compliance with regulatory requirements, including FDA’s 21 CFR Parts 11, 210 and 211.