Built for pharma & biotech QA teams

From rough draft
to audit‑ready.
In minutes.

Four reviewer personas read every SOP from their own failure mode. Iterate to audit-ready, then export tracked-changes .docx straight into your QMS. Knowledge silo learns your house style as you go.

Get startedDesign partner programme · Limited cohort through Aug 2026
SOPCleanroom cleaning procedure · MFG-001

Section 4 · Cleaning procedure

Findings · 4

All 11 reviewed
Define particulate count thresholds
CriticalFDA Inspector·§ 4.2 Environmental
Cleaning interval is ambiguous
MajorQA Manager·§ 4 Step 7

Fix

Add glove-change checkpoint
MinorOperator·§ 4.1 PPE
Visual ref. for swab pattern
MinorTrainer·§ 4.4 Sampling
GMP·GLP·ICH Q10·Cleanroom·FDA 21 CFR·ISO 13485·Change Control·CAPA·Deviation·Validation·QMS·Audit Trail·GMP·GLP·ICH Q10·Cleanroom·FDA 21 CFR·ISO 13485·Change Control·CAPA·Deviation·Validation·QMS·Audit Trail·
Four roles

Inspector · QA · Operator · Trainer

vs. one QA Manager covering all four

Iterate

Draft → review → revise

vs. one-shot AI prompts

Your style

Knowledge silo learns your house

vs. starting from zero each SOP

EU-hosted

Azure · Sweden Central

vs. wherever your AI vendor put it

Sound familiar?

The problems
every QA team shares.

Word and a checklist is what you have today. It doesn't scale past one quality manager.

Four reviewer personas — Inspector, QA manager, operator, trainer — read every SOP from their own failure mode in parallel. The bottleneck stops being one person's calendar.

Compliance platforms tell you what to review and when. They don't help you do the review.

Adem reads the procedure with you. Each finding is line-level and actionable — accept, reject, edit. Then export tracked-changes DOCX straight into the QMS you already have.

Generic AI gives you a smart reader. 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, your prior decisions get captured — so the next review starts from what you already know, not from zero.

How it works

Upload now.
Export before lunch.

SOP-MFG-001.docx

Drop or click to upload

01Under 2 minutes

Upload or generate

Paste an existing SOP, upload a DOCX, or pick from 28 presets across operations, QA, training, and safety. You start from something already shaped the way your auditor expects.

  • DOCX / PDF upload
  • 28 SOP presets · 7 categories
  • AI template matching
FI
QA
OP
TR
CR
AU
VA
SF
DC
LB
RA
02Draft → review → revise → re-review

Four reviewers, then iterate

Inspector, QA manager, operator, trainer — each reads the SOP from their own angle. Triage the findings inline, regenerate, run the panel again. Real iteration history, not a one-shot prompt.

  • Multi-persona panel (4 core + 15 specialists)
  • Severity-classified findings
  • Visible iteration history
  • Real exit conditions
All findings resolved
W

SOP-MFG-001-v2.docx

42 KB · Ready

03Tracked changes straight to .docx

Approve, export, audit

Save explicit "this is the approved version" checkpoints. Export with redlines and paste into your QMS. The audit trail records every action — author, action, timestamp — and survives long after the review is over.

  • Version checkpoints + time-travel
  • Tracked-changes .docx export
  • Append-only 10-year audit log
  • Exportable for inspectors

Why Adem

Not

Word + a checklist

One QA, ten weekendsFour reviewers in parallel

The most common SOP review process today. Works — until you scale past one quality manager. Adem reads every SOP from four angles in parallel, so the bottleneck stops being one person's calendar.

Not

Compliance platforms

What & whenWhat & how

Greenlight, Qualio, MasterControl tell you what to review and remind you when. They don't read the SOP with you. Adem does the actual review — line-level findings, tracked changes, ready to land in whatever QMS you already have.

Not

Veeva-class eQMS

$200K · 6 monthsBeta access · same day

No implementation partner, no contract, no months of onboarding. Sign up, paste a SOP, export a DOCX with redlines — all before lunch. The architecture that grows into an eQMS is there; you don't pay for it until you need it.

Built like a system of record

Designed to the standard,
before the certificate.

We're not ISO 27001 certified yet — and we'll tell you that to your face. The architecture was built to those controls from day one, and the security posture 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.

Zero-data-retention APIs

OpenAI / Anthropic enterprise endpoints. Document content is seen only during the active request, never retained, never used to train a model.

See your SOPs reviewed properly.

Currently onboarding a select cohort of design partners through August 2026. Tell us about your team and your SOP workload — we'll reply within a working day.

30-day exit clause
Signed DPA on request
Reply within 24h
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