All investigations, be it for complaints, non-conformance, incidents, or OOS, are governed by regulations. For instance, the regulatory requirements for OOS investigations are detailed under Section 21 CFR 211 of Current Good Manufacturing Practice for Finished Pharmaceuticals and include:
211.84 Components, product containers, and closures need to be tested and approved or rejected based on results
211.113 Microbiological contamination needs to be controlled
211.160 Lists general requirements
211.165 Covers the testing and release for distribution
211.194 Lays requirements for laboratory records of testing and validation, ensuring the conforming of components, containers and closures, in-process materials, and finished products to specifications.
ComplianceQuest Investigation Management Software is built to align with the major regulations and standards such as FDA, MDR, and ISO. As a result, implementing the solution helps organizations become compliant. The workflows are automated, making it easy to keep pace with changes in regulations and also cater to the local regulatory needs of different geographic locations.