Activity

  • I agree that deviations are important to keep included in both validations and verification reports. Deviations can provide important information that ultimately can change the whole output or scope of the verification. There was a verification protocol/report that I was aiding with in which there was not enough test coupons to meet the requirements that were set forth in the protocol. The scope had to be narrowed to just include one of the materials that were to be tested rather than both. The deviation we put in was that an addendum would be drafted and attached to the protocol and be completed at a later time when there as enough material available.