What are the regulatory requirements for software validation?

What are the regulatory requirements for software validation?

Regulatory requirements for software validation vary by industry, but generally include ensuring software meets user needs and intended uses.

Can you give me examples of specific regulations?

Sure! In the medical field, FDA guidelines require software validation to ensure safety and effectiveness. In finance, there are regulations like SOX.

How do I ensure compliance with these regulations?

To ensure compliance, you should follow a structured validation process, document all procedures, and conduct regular audits.

What documentation is necessary for software validation?

Necessary documentation typically includes validation plans, test cases, test results, and change control records.

Are there any tools that can help with software validation?

Yes, there are several tools available, such as TestRail for test management and JIRA for issue tracking, which can aid in the validation process.