Computer system validation and qualification consultancies serving pharma, biotech and medical devices: the deliverables get generated, the judgment stays yours.
Knowing what an inspector will actually challenge - and where risk-based means lighter rather than longer - is earned in audit rooms, not in guidance documents. That judgment is the part of your service nobody can copy.
Reading the inspector: which records get pulled, which justification survives a challenge, where the depth of testing has to go.
URS through PQ drafting, traceability upkeep, screenshot evidence, formatting, and re-typing the same protocol for the next client.
Your validation approach becomes the system’s standard: the software produces the pack, your reviewers rule on the exceptions.
Not a chatbot in your inbox. Whole workflows in production - across every person and system they touch - on one layer that the next workflow reuses.
A system description in, the full set out: URS, FS, DS, IQ, OQ, PQ, drafted to your templates. Today that is two to six weeks of a consultant’s drafting time per system.
Requirement-to-test traceability built as the documents are written, and maintained when any one of them changes - instead of a spreadsheet reconciled by hand before every audit.
Executable scripts generated from the specifications, with screenshots, timestamps and signatures captured as execution happens rather than assembled afterwards.
Deviations written up, impact assessed and change control records drafted from what actually changed - the admin that currently fills the days between test runs.
Annual and periodic reviews compiled from the live record: current configuration, open deviations, training, incidents. A week of evidence-chasing becomes a review.
A vendor’s test specification compared clause by clause against the client’s URS, with the gaps you would otherwise have to test yourself listed and priced.
Undocumented legacy systems assessed against current expectations, with the remediation scope evidenced instead of estimated.
A validation platform your clients run themselves for routine systems, with your firm as the approving authority. They stop paying consultants to draft; you stop selling hours to draft. The approval - the part that carries your name and your liability - stays with you.
Licence revenue on routine validation that does not consume a consultant’s week, alongside the complex qualifications your people still run themselves.
Every site already validating with you is a day-one customer. No software company can enter this market without your credibility.
The platform produces the pack; your firm signs it. That dependency is durable in a way a software subscription on its own never is.
Life-sciences quality software became one of the largest vertical software categories in existence by turning regulated paperwork into a system of record. The same pattern has never been built for mid-size computer system validation. And in a regulated environment nobody buys validation software from people who have never been in front of an inspector - which is why it has to come from a consultancy, and why it can be yours.
Code, models, prompts and runbooks transfer to your firm. If we disappeared tomorrow, the system keeps running.
The second workflow costs a fraction of the first, because permissions, integrations and audit trail are already built.
Human-approved gates, evidence on every output, electronic records and signatures handled properly, ISO 27001 and GDPR alignment, deployable in your own environment.
Our engineers sit inside your practice until it runs - then your people build on it, not just operate it.
We invest €50,000 of engineering into one real process inside your firm. Two minutes to apply, twenty to find out if you are a fit.