GxP Computerised Systems · SOP Template Suite
Sixteen SOPs and sixteen forms. One numbering system. Built for 21 CFR Part 11 and EU Annex 11.
A complete, cross-referenced starting point for managing GxP computerised systems — access control, validation, change control, audit trails, electronic signatures, data integrity, and more. Drafted from public FDA, EMA, ICH, and GAMP 5 guidance, with guidance notes marking exactly what to customise for your organisation.
Editable .docx files · Instant download · One-time payment
Who this is for
Built for teams setting up their first GxP quality system
If you're a new or small CRO, an early-stage biotech or medical device company building your computerised systems quality framework for the first time, or a fractional QA/regulatory consultant supporting several small clients — this suite gives you a complete, cross-referenced starting point without waiting weeks for someone to draft it from scratch.
Hiring a consultant
$10,000–$25,000+
Independent GxP/CSV consultants commonly charge $150–300 per hour. Drafting, reviewing, and cross-referencing a 16-document SOP suite from scratch is typically weeks of work — before you've adapted a single template to your organisation.
Controlled·Copy
$699
All 16 SOPs and 16 matching forms, already cross-referenced and aligned to 21 CFR Part 11, EU Annex 11, and GAMP 5. Work through the included Customization Checklist to adapt them — typically hours per document, not weeks.
Page 1 of 5 — SOP-QA-004, Change Control for GxP Computerised Systems
Preview · SOP-QA-004 Change Control
See what's actually inside
Every document in the suite follows this structure. This is the first page of SOP-QA-004 — Change Control for GxP Computerised Systems, one of the 16 SOPs included.
Document control header — company name, document number, version, and approval roles, identical across all 32 files.
Purpose, Scope, Responsibilities, Definitions — sections 1–4 in every document, explaining what it covers, what it doesn't, and who's accountable.
Procedure or Policy Requirements — section 5, the working content, shaped to what each document actually governs.
References, Regulatory Mapping, Appendices, Revision History — sections 6–9 close every document the same way, with its regulatory basis mapped and a version table ready for sign-off.
From download to controlled document
These are templates, not magic — here's exactly what happens after checkout.
Download
Get instant access to all 16 SOPs and 16 matching forms as .docx files, plus the Master Document List and a Customization Checklist that walks through every document.
Customise
Work through the checklist: set your numbering convention, risk bands, retention periods, and role titles. Guidance notes mark exactly where a decision is needed.
Approve
Route the finished documents through your existing review and approval process, then issue them as controlled documents.
Buy by pack, or get everything
Every pack is a one-time purchase with instant delivery. Mix and match, or save with the complete suite.
Complete suite
All 16 SOPs, 16 forms, Master Document List, and Customization Checklist
Everything above in one purchase — the full governance, compliance, validation, and operational framework for GxP computerised systems, with every matching form included.
Questions before you buy
Are these documents audit-ready as-is?
No — they're a structured starting point, not a finished quality system. Every document includes guidance notes marking the decisions that need your organisation's input (numbering, risk bands, role titles, timeframes) before they're ready for internal review and approval.
What do I actually receive?
16 SOPs and policies plus 16 matching forms — 32 editable Microsoft Word (.docx) files in total — along with a Master Document List and a Customization Checklist. Delivered as an instant download after checkout. No physical product, no account required.
Can I use my own branding and document numbering?
Yes. Every document is fully editable. SOP-QA-001 (Document Control and Management) also includes guidance on establishing your own numbering convention if you'd rather not use the one provided.
Is this legal or regulatory advice?
No. These templates are built on hands-on GxP and computerised systems experience, structured around FDA 21 CFR Part 11, EU GMP Annex 11, ICH guidance, and GAMP 5. You're responsible for ensuring your final documents meet your organisation's regulatory obligations, and we'd recommend having them reviewed by qualified QA or regulatory personnel before issue.
Can my whole team or company use one purchase?
Yes — each purchase is licensed for use within a single organisation. The files are yours to adapt, copy, and issue internally as controlled documents.
What if I have a question after buying?
Reach out to us at info@controlledcopy.com and we'll get back to you.