GMP document review & inspection-ready templates.
Upload your SOPs, validation protocols, and batch records. CQMP compliance specialists review each document against FDA, EU GMP, and ISO standards — and return a detailed findings report with gap analysis, risk ratings, and corrective actions.
Watch the overview
Two ways to strengthen your GMP compliance
Whether you need expert eyes on your existing documents or inspection-ready templates to build from, CQMP has a product for every stage of your compliance journey.
GMP Document Review & Template Packages — CQMP
Expert compliance services for regulated industries
Why it matters
What you get with every review
More than a compliance check — a structured, expert-led review that prepares your documentation for inspection.
Expert compliance review
Every document is reviewed by a CQMP compliance specialist against FDA, EU GMP, and ISO 13485 standards — not a checklist tool.
Gap identification & risk rating
Each finding is rated by risk level — critical, major, or minor — so your team knows exactly where to focus remediation efforts.
Actionable findings report
You receive a structured report per document with specific corrective action recommendations, not vague observations.
Secure portal delivery
Documents are uploaded and returned through your private CQMP portal. Nothing is shared outside your account.
Fast, predictable turnaround
Packages come with a defined turnaround window so you can plan your compliance timeline with confidence.
Audit-ready documentation
Reviewed documents and findings reports are stored in your portal, ready to present during an FDA or EU GMP inspection.
Simple process
From upload to findings in four steps
Register for the portal
Create your CQMP client account at no cost. Takes under two minutes.
Choose your package
Select the review tier that matches your document volume — Starter, Professional, or Enterprise.
Upload your documents
Upload SOPs, protocols, batch records, or any GMP documentation directly through your secure portal.
CQMP reviews & returns findings
Our compliance specialists review each document and upload a detailed findings report back to your portal.
What we review
Any GMP document your team produces
Our compliance specialists are experienced across the full range of GMP documentation — from foundational SOPs to complex validation packages. If it needs to survive an inspection, we can review it.
Start your first reviewStandards coverage
Reviewed against the regulations that matter
FDA 21 CFR Part 11
Electronic records & signatures
FDA 21 CFR Part 820
Quality system regulation
EU GMP Annex 11
Computerised systems
ISO 13485
Medical device quality systems
ICH Q10
Pharmaceutical quality system
GAMP 5
Risk-based validation
Template packages
Start with inspection-ready GMP templates
Download professionally authored, regulation-aligned document templates. Use them as a foundation — then submit them for expert review when you're ready.
SOP Template Bundle
A complete set of Standard Operating Procedure templates covering manufacturing, quality control, and facility operations — formatted to FDA 21 CFR and EU GMP requirements.
- 15+ SOP templates included
- FDA 21 CFR & EU GMP aligned
- Word (.docx) format — fully editable
- Covers manufacturing, QC, and facilities
- Instant download via your portal
Quality System Starter Pack
Everything you need to establish a documented quality management system from scratch — policies, procedures, and forms aligned to ISO 13485 and ICH Q10.
- Quality manual template included
- ISO 13485 & ICH Q10 aligned
- CAPA, deviation, and change control forms
- Management review and audit templates
- Instant download via your portal
Validation Protocol Pack
IQ, OQ, and PQ protocol templates for equipment, process, and computer system validation — structured to satisfy GAMP 5 and FDA 21 CFR Part 11 requirements.
- IQ / OQ / PQ protocol templates
- GAMP 5 & FDA 21 CFR Part 11 aligned
- Computer system validation (CSV) templates
- Validation summary report template
- Instant download via your portal
All templates are delivered digitally through your CQMP portal immediately after purchase. Register to purchase.
Document review packages
Submit your documents for expert review
Register for your portal account, select a review package, and upload your documents. Our compliance specialists handle the rest.
Starter
- Up to 5 GMP documents reviewed
- Compliance findings report per document
- Gap analysis vs. applicable regulations
- Risk rating per finding (critical / major / minor)
- Recommended corrective actions
- Secure portal upload & delivery
Professional
- Up to 10 GMP documents reviewed
- Compliance findings report per document
- Gap analysis vs. applicable regulations
- Risk rating per finding (critical / major / minor)
- Recommended corrective actions
- Secure portal upload & delivery
- Priority review queue
Enterprise
- Up to 25 GMP documents reviewed
- Compliance findings report per document
- Gap analysis vs. applicable regulations
- Risk rating per finding (critical / major / minor)
- Recommended corrective actions
- Secure portal upload & delivery
- Priority review queue
- Dedicated compliance consultant
- Executive summary report
Pricing is confirmed upon registration. All packages include secure document handling and a dedicated CQMP compliance reviewer. Need a custom volume? Contact us.
Ready to get started?
Your next inspection starts with your documents.
Register for your CQMP portal account, download templates to build from, or submit your documents for expert review. One platform, every compliance need.