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This is a major problem and one of the artifacts of the reg not having been updated since 1997. The industry expectation for the validation process is for it to
by zbjornson 7y ago
This is a major problem and one of the artifacts of the reg not having been updated since 1997. The industry expectation for the validation process is for it to take four to six months, and it's specific to one version. We have 99.99% of our software requirements specification testing covered by several thousand automated tests that run in several minutes. Nonetheless, auditors have been wary of frequent updates, even though by their own admission our test strategy is far superior to any manual testing strategy and, critically, is the only realistic way to monitor for regressions specific to our usage of software that the vendor might not catch.
- agentultra 7y agoI don't disagree. The validation process is hilariously outdated as are the compliance requirements for software vendors. But it's ambiguous enough in places that we can adapt some modern operations tooling and practices to it.