Built for pharma & biotech QA teams and consultants
Adem reads your deviations, CAPAs, change controls and SOPs line by line and backs every finding with the exact EU GMP, 21 CFR or ICH clause. You accept or reject each one, and your QMS gets a tracked-changes DOCX with a full audit log.
Three-month scoped pilot · one document family · no annual commitment until you have evidence
Section 4 · Cleaning procedure
4.2 Prepare the disinfectant solution per the manufacturer's instructions and record the lot number in the cleaning logbook. Particulate counts are checked regularly and recorded.
4.3 Wipe all horizontal surfaces with a sterile low-lint wipe, working from the cleanest to the dirtiest area. Cleaning is repeated at appropriate intervals.
4.4 Dispose of used wipes in the designated waste container and sign the cleaning record.
Findings · 0
0/8 reviewedBuilt around the standards you're audited against
What you get
Four outcomes QA teams and consultants use Adem for.
Read everything. No more sampling.
Adem reads every page and returns findings anchored to the exact line, ranked by severity, each citing the governing EU GMP, 21 CFR or ICH clause.
Near-final drafts from your sources, in your template.
Hand over audit notes, batch records or the old revision. Adem drafts the deviation, CAPA or report in your house template and reviews its own draft before you read it.
Changes arrive as redlines in the original file.
Describe a change once and run it against each affected document: tracked changes in place, automatically re-checked, nothing retyped. Headers, footers and numbering stay intact.
Fits the QMS you already run.
Word in, Word out: the tracked-changes DOCX checks straight into your existing QMS. Every finding and decision is logged automatically along the way and stays retrievable for ten years.
Grounded, not generated
You should not have to take an AI at its word. Every finding shows its source, every review is documented, and everything stays in your file and your tenant.
Every finding names its clause
Findings cite the exact EU GMP, 21 CFR or ICH clause they rest on, from a regulation library we keep current as authorities publish. You can open the clause and check it yourself.
Every review is traceable
Every finding is anchored to the exact paragraph it refers to, and every run is logged: which document version, which findings, which decisions. When someone asks how a result came about, you can show them.
Tracked changes in your file
Edits land as Word tracked changes inside your original DOCX, headers, footers, numbering and tables intact. Not a rewrite pasted into a text box.
Your knowledge stays yours
Equipment IDs, terminology, templates and past review decisions feed every review and draft. They live in your tenant and are never used to train a model.
See it on one of your own documents this week.
Get startedThe tool is great. Much better than two other tools we evaluated.
Scientific Director
Novo Nordisk · 2026
In active discovery across
Built for regulated work
Adem is built for pharma requirements from day one: hosted in Europe, strictly separated per customer, every step traceable. We are preparing ISO 27001 and ISO 42001 certification; the concepts behind both are documented today and open to pilot customers.
Hosted in Europe
Your documents are processed and stored in the EU, on Microsoft Azure. Frankfurt available on request.
Encrypted in storage
Your content is encrypted a second time inside the application, on top of the data centre's standard encryption.
Separated from other customers
Each organization gets its own technically separated area of the database. No shared data space.
Deleted means deleted
One click deletes your account and removes identifying data. The audit trail itself is preserved, the way inspectors expect.
A complete audit trail
Every finding and decision is recorded and cannot be altered afterwards. Kept for ten years, exportable for inspections.
No training on your data
Your documents are processed only to answer your request and never used to train AI models, not by us and not by our AI providers.
Citations you can look up
Every requirement names the exact EU GMP, 21 CFR or ICH clause, with source and version, so you can check it yourself.
Common questions
New SOPs are the smallest part of the load. Every controlled document needs periodic re-review, and the day-to-day volume is deviations, CAPAs, change controls, audit reports and validation protocols. Adem reviews and drafts all of them. Pricing is per-affiliate, not per-document, so the value tracks your whole controlled-document portfolio and your audit exposure, not how many new SOPs you author in a year.
Three-month scoped engagement on one document family at one site. We agree decision criteria at kickoff: usually a mix of hours saved per document, gap-detection accuracy vs. your QA team's manual baseline, and reviewer satisfaction. No annual commitment until the pilot's evidence is in.
No. Content sent to AI models is never used to train them, contractually guaranteed. We run on OpenAI and Anthropic enterprise endpoints; your document content is processed only to fulfil your request, not to train a model.
Microsoft Azure, Frankfurt by default. Your documents stay in the EU — no transatlantic transfer.
No. We sit above your QMS, not in place of it. Export tracked-changes .docx and paste into whatever system of record you already use. We're not asking you to rip-and-replace.
Certification for both is in preparation, not yet underway. The architecture was built to the ISO 27001 security controls from day one: EU residency, tenant isolation at the database schema layer, append-only audit log, encrypted at rest. It's also built to ISO 42001 for AI governance: documented model risk assessment, human oversight, and lifecycle controls. The posture for both is documented and open to pilot partners.
Pilot first · Decide after
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