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.
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.
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.