Drug development, laboratories, clinical trials, manufacturing
Pharma and life sciences
A result is only as good as the proof of what produced it.
Drug development runs on data integrity. Regulators expect every result to be attributable, original and accurate. That expectation now reaches instruments, lab automation, AI models and cloud pipelines that change every month. Validation is done once, at qualification. The software keeps moving.
Who this is for
- Pharma and biotech companies, from discovery to manufacturing
- Contract research and manufacturing organisations, that have to show sponsors what they ran
- Lab instrument and automation vendors, whose machines produce regulated data
- AI drug discovery companies, sharing models and data with partners
Where the problem shows
An instrument or lab robot gets a software updateIt was qualified with the old version. Its next result needs to be tied to what actually ran.
An in vivo or imaging system records study dataThe record is evidence for an approval. Its origin and the software that captured it should be provable years later.
Partners train a model on each other's compoundsNeither side wants to reveal its library. Both need proof that only the agreed training code saw the data.
A manufacturing line changes a recipe or controllerBatch records should show the controller's state, from the controller.
An inspector asks how a result was producedThe answer should include the software and model versions, with evidence.
What we deliver
- Attestation for instruments, lab automation and analysis pipelines, so each result carries proof of what produced it.
- Joint computation between companies in attested environments, with rules for code changes.
- A link between computerised system validation and continuous evidence, so a change does not silently end the validated state.
- Evidence mapped to GxP data integrity rules, including EU GMP Annex 11 and 21 CFR Part 11.
Questions worth answering
- Can you prove which software version produced a result from three years ago?
- When a partner runs your data, what shows which code touched it?
- How do you know a qualified system is still in its qualified state?
Across the life cycle
DesignBuildMake or deployOperateUpdateRetire
The stage that decides here: design. Validation happens at design and qualification. The gap is everything afterwards, while the validated system keeps changing. See attestation in the product life cycle.
Rules your buyers cite
GxP data integrity rulesGDPREU AI ActCyber Resilience Act
Our work in this industry
Attested AIAI passportAttested OT and industrial controlAttested devices
Go deeper
Working on pharma and life sciences? A first call takes 30 minutes and commits you to nothing. Bring your product and the one question that worries you.
Next fixed date: EU Digital Identity Wallets are due in every member state on 24 December 2026, 42 days from now.