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OOS and OOT investigations are an essential part of clinical testing and development, but it is a complicated process that requires a “right from the first time” approach. It requires visibility into the investigation processes, documentation, follow-up action, and regulatory submissions. Of course, it also requires ensuring that the product is not pushed into the market before the investigations are completed, and corrective action is taken.

Since collaboration is essential, keeping everybody updated, assigning tasks, and following up to make sure the required action has been taken as specified can add to the complexity. Lab investigations can also be time-consuming and lack the consistency or thoroughness needed to be compliant with the regulatory standards. It requires instructions and processes to be easy to follow for all key stakeholders. It should be comprehensive and thorough, compliant, well-documented, and right the first time.

Overall, it is also critical that the overall lab investigation process is

  • Efficient: decreases the time needed for investigations with increased quality and process efficiency
  • Insightful: identify trends for root cause analysis by tracking the results of all your investigations
  • Cost Saving: with decreased cycle time and task automation
  • Compliant: makes sure your investigations adhere to regulatory standards
  • Documented: all steps, assessments, results, checklists and findings are well documented and easily shareable/printable

ComplianceQuest’s Lab Investigation Solution ensures a systematic, efficient, and compliant approach to laboratory investigations. It facilitates seamless collaboration between various teams that can be located in different geographical areas as it is cloud-based.

In this whitepaper, we talk about:

  • Regulatory requirements for lab testing
  • Phase 1 Investigation: Finding an assignable laboratory cause
  • Phase 2 Investigation: Production review
  • Lab investigation challenges
  • Automating OOS/OOT investigations with ComplianceQuest
  • And more

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