Testing is done, the software is released.

What could go wrong?

Audits and auditors!

The reality that everyone in a regulated industry faces.

You can mitigate potential problems by preparing a Validation Pack that contains:

  1. User requirements
  2. Supporting documentation (internal and external – User Manuals, Maintenance Manuals, Administration Manuals, and so on)
  3. Vendor data (Functional Specifications, FAT, SAT, Validation Protocols)
  4. Design documentation; Executed protocols
  5. An archive copy of the software (including libraries, data, and so on)
  6. Protocol execution results
  7. The test report
  8. A known bug list with impact assessment

Then, when the auditor asks whether the software has been validated, present the Validation Pack (or at least take them to the relevant library).

You’ll make his or her day.