Testing Computers Systems for FDA/MHRA Compliance

There is no substitute for extensive testing when it comes to IT systems. Recognition that problems are easier and cheaper to fix before the system is in use (rather than after), has turned testing into a cost-effective tool. However, when developing computer systems for pharmaceuticals manufacturing, testing to meet regulatory requirements adds an

Inhalt

Purpose. Scope. Why Do We Test? What to Test. The Test Strategy. The Development Lifecycle of a Test Specification. Recommended Content for System Test Specification(s). Good Testing Practices. Supplier System Test Reports/Qualification. The Use of Electronic Test Management and Automated Test Tools. Appendices.