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IT Services
We build and validate applications with validation evidence, data integrity and traceability treated as first-class requirements, not bolted on the month before an audit.
The problem
A system gets built to a functional specification, works well in demonstration, and then someone asks for the traceability matrix. What follows is weeks of retrospective documentation, written by people reconstructing decisions they were not part of, against requirements that were never written to be testable.
The documentation that comes out of that process is thin in exactly the way inspectors probe. It also makes every future change expensive, because nobody can tell which test covers which requirement.
We write requirements to be testable from the start, and produce the evidence as the system is built. It is not slower. It is only front-loaded.
Tell us the problem. A specialist replies, not a form robot.
What we do
Scoped to your actual workflow rather than a product you have to bend around.
CSV for LIMS, eQMS, ERP, MES and bespoke systems.
Selection, configuration and rollout without inflating the IT budget.
Retainers that keep validated systems in a validated state.
21 CFR Part 11
The standard every build is written against
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Questions
Yes, and that is a large part of the work. Inheriting someone else's system is common, and the first job is usually establishing what evidence exists before deciding what has to be produced.
That is the design intent, and we treat handover as a deliverable rather than a courtesy. Documentation, knowledge transfer and a support period are written into the scope.
Attributable, legible, contemporaneous, original and accurate, enforced by the system rather than by procedure. In practice: audit trails that cannot be disabled, controlled electronic signatures, and no shared accounts.
Yes. The validation approach differs, because you are validating configuration and supplier qualification rather than the underlying platform, and the supplier assessment matters more than most teams expect.
They degrade quietly. Patches lapse, integrations drift and documentation goes stale. That is precisely what a support retainer is for, and it is cheaper than the revalidation that follows a finding.
Related
Judge us on the shortlist, not the sales deck.