A validation pack is not a methodology. These five artifacts carry an inspection — and each one fails in a predictable place.
A "validation pack" is not a methodology. It is a folder of templates, and a folder of templates does not survive an inspection. What survives is a small set of artifacts that are coherent with each other and that were produced as the system was built, not reconstructed after go-live. There are five of them. Each one carries a specific burden of proof, and each one fails in a predictable place. Here is what each must prove — and where most implementations go quiet.
What it must prove: that the system's intended use was defined, in the regulated company's own language, before configuration began — and that every later decision traces back to it.
The URS is the root of the traceability chain. It states what the system must do, who needs it to do that, and which requirements are GxP-critical. Everything downstream — the configuration, the tests, the summary — points back here.
Where most go wrong: the URS is written after the system is already configured, to match what was built. An auditor can tell. A requirements document that perfectly describes the as-built configuration, with no tensions or trade-offs visible, is a reconstruction, and a reconstruction cannot have driven the design it post-dates. The URS has to come first and bear the marks of having come first.
What it must prove: that every setting that matters was a decision, with a rationale, traceable to a requirement.
This is the document that says: here is how the system is configured, and here is why each configuration was chosen. Posting setups, approval workflows, security roles, electronic-signature points, audit-trail settings — each captured with the reason it was set the way it was.
Where most go wrong: this is the artifact that most often does not exist. Generalist implementations configure the system competently and never write down why. "Best practice" is offered as the rationale, which is to say no rationale at all. At inspection, the configuration specification is where auditors push hardest, because it is where the gap between "it works" and "we can defend it" is widest.
What it must prove: that every requirement maps to a configuration and to a test, in both directions, with nothing orphaned.
The traceability matrix is the spine. Requirement to specification to test, forward and backward, so that you can show any requirement is satisfied and tested, and any test exists for a reason. It is the single artifact that demonstrates the whole effort is coherent rather than a pile of unconnected documents.
Where most go wrong: the matrix is built at the end, from the finished documents, as a clerical exercise. A matrix assembled after the fact tends to be suspiciously complete — every cell filled, no gaps, no deviations — which is itself the tell. A matrix maintained from day one shows its history: requirements that changed, tests that failed and were rerun, decisions that moved. That texture is what makes it credible.
What it must prove: that the system was installed correctly, operates as specified, and performs against pre-approved acceptance criteria — executed, with evidence.
Installation qualification confirms the environment is built and configured as specified. Operational qualification confirms the functions work as intended across their range. Performance qualification confirms the system performs in the actual business process, against acceptance criteria written and approved before execution. Protocols and their executed reports are distinct artifacts; you need both.
Where most go wrong: acceptance criteria written after the test is run, to match the result. The discipline that makes IQ/OQ/PQ meaningful is that the criteria are approved before execution, so the test can genuinely fail. Where the criteria are reverse-engineered from a passing run, the qualification proves nothing — and a deviation log that contains no deviations across a complex implementation invites exactly the scrutiny it was meant to avoid.
What it must prove: that everything above ties together and that the system is fit for its intended use — in one signed document.
The VSR is the capstone. It references the plan, the requirements, the testing, and the deviations, states what was done and what was found, and concludes that the system is validated and fit for use. It is the document your CFO hands the board and the one your auditor reads first to decide how hard to look at everything else.
Where most go wrong: the VSR asserts a clean conclusion that the underlying artifacts do not support. A summary that claims full validation over a traceability matrix with gaps, or that waves past unresolved deviations, does not strengthen the package — it gives an inspector a thread to pull. The VSR has to be honest to its own evidence, including the deviations, with their justifications visible.
Read the five together and the pattern is obvious: the artifacts are not the point. The timing and the traceability are. Each of these documents can be produced after go-live, and each, produced that way, fails in the same direction — too clean, too complete, too obviously built backward from the finished system. Produced as the implementation happens, by the team that made the decisions, they carry the marks of real work and they cohere. That coherence is what an inspection actually tests.
A few artifacts sit just outside this five and deserve a mention: the validation plan that scopes the effort and the risk classification that justifies the depth of testing, both produced up front; and the periodic review template that keeps the system validated after go-live. They are not optional. But if you produce only five things and produce them honestly, produce these.
At Aperigon these are not a separate validation deliverable bolted onto an implementation. They are outputs of the implementation, written by the same senior team that configures the system, so the document your auditor reads is the document we designed from. We are publishing the templates — URS through validation summary report — to our artifact library. Until then, the test of any validation effort is simple: ask to see these five, and ask when each was written.
Aperigon delivers Microsoft Dynamics 365 to Life Sciences companies — validated by design, inspection-ready on day one. If your current implementation is missing any of these five, start a conversation.