Possibly the most critical aspect of the MVP is to establish a consistent approach to how issues arising during validation are handled.

Test Failure

The most obvious issue is a test failure.

The MVP describes the methods for documenting, assessing, and dispositioning test failures.

Small Team

The failure is typically assessed by a small team (e.g., quality representative and representative from the function using the software) to determine how to address the failure.

The failure could be a result of:

• The software failing
• An incorrect protocol
• The tester misinterpreting results
• Or the tester not following the protocol correctly

Resolution of software failures could include:

• Changing the software using proper change and configuration control methods defined in your lifecycle!
• Avoiding the issue procedurally (e.g., restricting users from accessing the feature)
• Accepting the failure (only if no risk)
• Or accepting the failure but instituting post-use controls to mitigate any issues (e.g. review and possible correction of data)