For organizations without validation resources, executing test scripts can be a long, tedious, time consuming project. QSI provides Software Validation Services to assure your system correctly meets the specifications of your organization and the regulatory requirements of your industry.
The team at QSI provides the expertise and test scripts (IQs, OQs, PQs) to perform validation quickly and accurately. Our validation binder includes a traceability matrix that provides mapping user requirements to the most popular features of a QMS system. For companies that are FDA regulated, we provide documentation that verifies compliance against the 21 CFR Part 11 regulation.
QSI’s IQ/OQ/PQ Validation Binder also includes:
- Validation Plan & Procedures Review
- Validation Execution and Screen Shots
- Exception Reports and Logs
- Vendor Analysis Report