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Regulated Industries
Product companies in regulated industries must be compliant to be successful. Critical processes of change, document, and quality management require regulatory compliance. Validation is a necessary burden.
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What You Get
User and Functional Requirements, Risk and Impact Assessments, Test Plans, IQ Test Cases, OQ Test Cases, OQ Execution & Objective Evidence, PQ Templates, Validation Report, Status Summary, Requirements Trace Matrix.
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Use Case
Our FDA CFR part 11 of Title 21 and pt 820 solution is focused on ease of use and efficient completion. Reduce your risk with a risk based approach, that is directed by FDA guidance. Avoid burden of on-prem upgrades, receive continuous benefit from Propel's innovations.