Investigate Out-of-Specification Results With FDA-Aligned Workflows

Automated OOS trigger from LIMS integration when test results exceed specification limits within this FDA compliant OOS management platform

Phase I (Laboratory Investigation): Checklist-driven lab deviation investigation system reviewing sample handling, instrument calibration, reagent validity, and analyst technique

Phase II (Full-Scale Investigation): GxP laboratory investigation software covering manufacturing process review, batch record analysis, and environmental data

Re-testing and re-sampling protocols with predefined decision trees and acceptance criteria as part of this regulatory compliant OOS system

Auto-generation of deviation and CAPA records when assignable cause is identified through out of specification investigation

Supervisor review and QA approval workflows with electronic signatures at each phase within this GMP OOS investigation software

Trending of OOS events by test method, product, laboratory, and analyst for systemic root cause identification via this lab deviation investigation system