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Compliance Operating System · Europe

European compliance that grows with your operation.

ComplyPharm turns EU GMP and GDP requirements into cited answers, controlled quality workflows and inspection-ready evidence — with qualified people in control.

Explore the platform View full capability map

EU

shared core

EU · EEA

European operations

HITL

human approval

Medicinal cannabis lifecycle Light
EU COREEU GxPINSPECTION

01 · Shared EU core

Requirements start with a trusted source.

EU GMP · GDP · Annex 11

One controlled chain

ComplyPharm workspace preview

One dossier

A focused preview of the connected records and decisions the team sees in the workspace.

Batch dossier

CP-EU-2026-0810

3 / 4 ready
Supplier COAVerified
EU GDP evidenceVerified
Annex 11 reviewIn review
Open workspace
Your process, step by step

From documents to a release decision.

Add the batch, check quality and licences in parallel, fix any gaps, then make one clear decision. Select a step to see what happens there and what comes next.

01 · ADD

Add the batch and documents

Create one place for the batch or operation. Add its source documents and the rules that apply, so the team starts from the same facts.

After this step, you have

Batch or operation
Relevant EU rules
Document checklist
Open workspace

Complete capability map

One operating system for Europeancited regulatory intelligence.

Turn an EU requirement into a verified answer, its operational context and the exact action it creates.

Current view

12

applicable requirements

Connected proof

EU GMP Annex 1

Version 2022

Primary sources verified

Next action

Review the impact on SOP-QA-014

Open

European by design

A shared European core. The right obligations for each operation.

ComplyPharm connects EU-level guidance with versioned applicability, authority evidence, licences, activity type and the decision trail required by your quality system.

European framework

EU GMP · Shared European quality core

EudraLex Volume 4 and its annexes provide the controlled basis for manufacturing and import workflows. ComplyPharm connects applicable requirements to the responsible operation, evidence and decision.

What the team should connect

Applicable GMP chapters and annexes

Controlled SOPs and quality records

Batch, facility and import evidence

European Commission · EMA

Open workspace

Human control is part of the system

AI helps locate risk. Qualified people make the decision.

Roles and responsibility

Each controlled step has an owner and the appropriate level of access.

Controlled approval

A suggestion never becomes a regulated decision without an authorised person.

Defensible history

Changes, comments, source evidence and approvals remain attached to the process.

Built on primary sources

Regulatory knowledge should always lead back to the authority.

Open a source to understand what it governs, why it matters operationally and what your team should verify before acting.

Operational source summary

EudraLex Volume 4

The operating baseline for how medicinal products are manufactured, documented and controlled.

What it covers

GMP principles, chapters and annexes for medicinal products for human and veterinary use.

Why it matters in ComplyPharm

ComplyPharm uses the applicable requirements as the regulatory basis for procedures, evidence reviews, gaps and controlled actions.

Use it to verify

Which chapters and annexes apply
Whether the current SOP set covers them
Which evidence supports implementation

Official source · European Commission

Open official source

Practical answers

Questions compliance teams ask first.

See ComplyPharm in action

Requirement, evidence and the next decision in one view.

Regulatory knowledge becomes accountable work: an owner, a deadline, a controlled record and a complete trail for the inspector.

European compliance workspace
Audit trail

Batch in progress

CP-EU-2026-0810

Distribution · European Union · Responsible Person

EU · EEA

Batch dossier

Every record enters one controlled batch dossier.

Batch dossier

3 / 4

documents ready

Next action

Attach distribution authorisation

Owner: Regulatory Operations · due today

Every response retains its source, jurisdiction and applicable version.
Licences, training, reviews and actions have accountable owners and visible status.
Connected evidence tells a complete story without rebuilding it before the inspection.