Course Code: ELM-113-02

Your 2 Minute Guide to Software Validation Deviations [Video]

Deviations are when an actual result differs from an expected result; these are often test failures. Deviations could occur due to a technical reason, or simply a typographical error on the part of the test script or document author.

Deviation Handling

Deviations could cause testing to stop cold while the deviation is analysed and a solution determined.

All deviations should be immediately raised to appropriate personnel (test co-ordinator, Quality Assurance, management).

Deviation handling is defined by company policy, but deviations generally should:

  • Stop testing until corrective actions are implemented; often in the case of typos, the tester can simply make a note in the comments section and continue
  • Allow testing to continue, but the deviation must be corrected prior to launch/release
  • Allow testing to continue, but the deviation will be acceptable for release (and will be corrected in a later release)
  • And be rejected if the deviation is a protocol error and the protocol redlined (or updated and re-released) before testing continues

Deviations are considered original data so they should not be “covered up,” even if the protocol is updated and re-released.

Author

Don Hurd

Practical Quality & Thorough Validation The Realtime Group