Built for pharma & biotech QA teams and consultants
The deviations, CAPAs, change controls and audit reports you review every week, checked line by line against EU GMP, 21 CFR and ICH. You decide every change. 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
Findings · 0
0/8 reviewedBuilt around the standards you're audited against
Sound familiar?
Where regulated-document review breaks today, and what changes the moment Adem runs the panel.
A checklist in Word doesn't scale past one quality manager.
A panel of specialized reviewers reads every document in parallel, each from its own failure mode. The bottleneck stops being one person's calendar.
Compliance platforms tell you what to review and when, not how.
Adem reads the procedure with you. Each finding is line-level and actionable: accept, reject, or edit. Then export a tracked-changes DOCX straight into the QMS you already have.
Generic AI gives you a smart reader with no audit trail, no version history, no house style.
Every iteration, every finding, every decision lands in an append-only audit log. Your terminology, your standards, and your prior decisions get captured, so the next review starts from what you already know instead of from zero.
Standing up a full eQMS takes months before you review a single document. And even then it manages documents rather than reviewing their content.
Adem complements your eQMS instead of replacing it: sign up today, paste a document, and export a tracked-changes DOCX before lunch that checks straight back into your existing system. No implementation partner, no rip-and-replace.
Why teams pick Adem
to first review
paste, review, export
years of audit trail
append-only, tamper-evident
hosted
Frankfurt, no transatlantic transfer
export
tracked changes, straight into your QMS
How it works
SOP-MFG-001.docx
Drop or click to upload
Paste an existing document, upload a DOCX, or start from a template for the documents you produce most: deviations, CAPAs, change controls, audit reports, validation protocols and SOPs. You start from something already shaped the way your auditor expects.
A panel of specialized reviewers each reads the document from its own failure mode. Triage the findings inline, regenerate, and run the panel again. Real iteration history, not a one-shot prompt.
SOP-MFG-001-v2.docx
42 KB · Ready
Mark a version as approved and lock it in as a checkpoint. Export with redlines and paste into your QMS. The audit trail records every action, author, and timestamp, and survives long after the review is over.
Roadmap
The document review engine ships today: a multi-agent reviewer panel that reads deviations, CAPAs, audit reports and SOPs, tracked-changes export, and a full audit trail. Cross-affiliate alignment is where we're headed, and the pilots we run shape what comes next.
Live now
Multi-agent document review
Specialized reviewer panel, severity-ranked findings
Grounded regulatory citations
Every requirement traces to a specific EU GMP, 21 CFR or ICH clause
Tracked-changes DOCX export
Redlines straight into your QMS
Company knowledge base
Your equipment IDs, forms & terms feed every review and draft
Append-only audit trail
Every action, author, timestamp · 10-year retention
Version checkpoints
Save approved versions, revisit any prior state
On the roadmap
Cross-affiliate global → local diff
NextOne corporate SOP, every local version aligned in one pass
Local regulation watcher
PlannedFlag documents when a cited regulation changes
Microsoft 365 embed
On requestReview inside Word & SharePoint
The tool is great. Much better than two other tools we evaluated.
Scientific Director
Novo Nordisk · 2026
In active discovery across
Built like a system of record
We're not ISO 27001 or 42001 certified yet, and we'll tell you that to your face. The security architecture was built to ISO 27001 from day one, and the way we govern the AI models we run is built to ISO 42001, the AI management system standard. The posture for both is documented and open to design partners.
EU-hosted
Microsoft Azure · Frankfurt available on request.
Encrypted at rest
AES-256-GCM application-layer on top of provider disk encryption.
Tenant isolation
Enforced at the database schema layer, not just in application code.
GDPR Art. 17
One-click account deletion. Audit trail preserved; identifying data scrubbed.
Append-only audit
Database-enforced. 10-year default retention. Exportable for inspectors.
No training on your data
OpenAI / Anthropic enterprise endpoints. Document content is processed only to fulfil your request, never used to train a model.
Grounded citations
Every requirement cites a specific EU GMP, 21 CFR or ICH clause, traceable to its published source and version. The model cites only from a vetted clause set, never paraphrased from memory.
Common questions
We only write a handful of new SOPs a year. Is this worth it?
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.
What does the pilot cover?
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.
Is my document data used to train AI models?
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.
Is the system agentic or deterministic?
Both, deliberately. A panel of specialized reviewer agents produces findings, each from its own failure mode. The orchestration layer is deterministic: dedup, severity ranking, prompt versioning, hash-keyed caching for reproducible reviews. Every finding is linked to the source paragraph. Every decision is logged. Happy to walk through the architecture on a call.
Do you compete with Veeva / MasterControl?
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.
Are you ISO 27001 and 42001 certified?
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.
30 minutes to understand your document review process, where the hours go, and what would need to be true for a pilot. One document family, one site to start. Decision criteria locked at kickoff.
Or book a 15-min call directly →