Still addressing out of specification/out of trend (OOS and OOT) manually?

FMCG, Food & Beverages and Pharmaceutical are few of the industries which are directly linked with the customers so they need to ensure the quality, efficacy and safety of their products. These industries now digital OOS and OOT.

In-spite of various seminars, trainings, and symposiums hosted by many big name companies, still many companies fail to comply with the FDA/GMP guidelines. Regulatory inspectors constantly found issues in the management of OOS and OOT. By definition the OOS and OOT is nothing but results that fall outside the set specifications or acceptance criteria established in drug applications, drug master file, and official compendium by the manufacture.

For effective management in Digital OOS and OOT, companies have established SOP to address the issues arises due to OOS and OOT situation. SOP includes all the necessary steps like checklist, phases and recommended timings to execute investigation or CAPA regarding OOS and OOT results. The whole procedure should be documented properly for audit purpose.

But manual methods are not error proof so the need of having a quality management system is in demand. Effective quality management system bring automation to address OOS and OOT to ensures potential product non-conformance are properly and efficiently investigated and handled through the tracking and managing of the initial report, phased investigation, root cause analysis and any resulting Corrective Action and Preventative Actions (CAPAs) and change controls.

Quality management system provide you FDA OOS guidelines with fully configurable workflows. The solution also integrates with other modules of quality management systems, giving you the flexibility to initiate CAPA based on OOS investigations, manage supporting documentation through a document management solution, and trigger personnel training through training management solution.

Reasons to upgrade to Digital OOS and OOT?

• Enhance transparency, control and productivity
• Mitigate time, cost and effort
• Ensures compliance with various regulatory and quality bodies
• Reduce risk of lost or incomplete data through closed-loop OOS process
• Provide flexible yet controlled environment through fully configurable process workflows
• Increases accountability though assignments, process step sign-offs and automated audit trails
• Decrease the risk of non-conformed products being released to market
• Lower customer complaints
• Improve brand and corporate image

 Are you ready to upgrade?