GxP Computerised Systems · SOP Template Suite

A complete GxP quality framework, 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.

Get the complete suite — $699 Browse all 34 documents

Editable .docx files · Instant download · One-time payment

Specimen

Computer System Validation

DepartmentQuality Assurance

Author[Name, Title]

Approver[Name, Title]

Effective Date[DD-MMM-YYYY]

ClassificationGxP

SOPs & Policies

Ready-to-use Forms

21 CFR

Part 11 Aligned

GAMP 5

Aligned

About Us

Controlled Copy was built by a team with over a decade of hands-on experience in contract research organisations, with expertise in GCP IT and QA overseeing computerised systems, validation programmes, and quality management infrastructure across multiple regulated environments.

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 14 SOPs, 2 policies, 15 matching forms, 2 registers, and 1 schedule, 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.

Packs

Browse the four packs below. Each includes the relevant SOPs, forms, and registers for that area. The Master Document List is included with every pack.

Foundation Pack

4 SOPs · 1 policy · 1 schedule · 1 register · 3 forms · recommended starting point

The governance layer everything else references — document numbering, risk scoring, vendor oversight, system inventory, and record retention — each SOP paired with its ready-to-use form, plus a controlled schedule. Includes the Master Document List register.

10 documents included

SOP-QA-001 Document Control and Management Defines how documents are numbered, reviewed, approved, and retired across your quality system.

SOP-QA-005 Risk Assessment Methodology A scoring model for classifying GxP computerised systems by risk, referenced throughout the suite.

SOP-QA-009 Vendor and Supplier Management Qualifying, monitoring, and exiting vendors and service providers for GxP systems.

SOP-QA-010 Computerised System Inventory Management A single register of every GxP system, its classification, and its owner.

POL-QA-002 Document and Record Retention Policy Retention periods, archival, legal hold, and controlled destruction for GxP records.

SCH-QA-001 Record Retention Schedule Pre-populated schedule of GxP record categories, regulatory retention basis, and periods to define — Appendix A of POL-QA-002.

FORM-QA-005 Risk Assessment Record Structured form for recording GxP impact, failure modes, risk scores, and mitigation actions.

REG-QA-002 Approved Vendor List Register of qualified vendors with risk classification, qualification method, and review dates.

FORM-QA-010 System Inventory Record Per-system record capturing classification, validation status, review schedule, and backup settings.

FORM-QA-013 Record Destruction Log Documents the authorised destruction of records at the end of their retention period.

Compliance Pack

3 SOPs · 1 policy · 5 forms

Covers Part 11 Subparts B and C — electronic records and electronic signatures — plus the data integrity policy and every form needed to evidence day-to-day compliance. Includes the Master Document List register.

9 documents included

SOP-IT-001 User Access Control Provisioning, periodic review, and removal of system access for GxP users.

SOP-QA-002 Audit Trail Review Risk-based review of audit trails for evidence of unauthorised or unexpected changes.

SOP-QA-011 Electronic Signatures Meaning, binding, and re-authentication requirements for e-signatures under Part 11 Subpart C.

POL-QA-001 Data Integrity Policy The ALCOA+ principles applied across every system and process in the suite.

FORM-IT-001 User Access Request Form Records access requests, business justification, training confirmation, and approvals.

FORM-IT-002 Periodic Access Review Record Documents the outcome of each user's periodic access review, per system.

FORM-QA-002 Audit Trail Review Record Captures review scope, findings, outcome, and QA counter-signature for each audit trail review.

FORM-QA-011 Electronic Signature Acknowledgement Record One-time acknowledgement and handwritten reference signature for each e-signature user.

FORM-QA-012 Data Integrity (ALCOA+) Self-Assessment Checklist Structured ALCOA+ assessment with a compliance outcome and CAPA table for identified gaps.

CSV Core Pack

4 SOPs · 3 forms

The full lifecycle of a GxP computerised system — from initial validation, through change and periodic review, to decommissioning — with the forms to record every step. Includes the Master Document List register.

7 documents included

SOP-QA-003 Computer System Validation A GAMP 5-aligned lifecycle approach, from Validation Plan to Validation Summary Report. Validation Plan and Validation Summary Report templates are not included.

SOP-QA-004 Change Control Classifying, assessing, and approving changes to validated systems.

SOP-QA-006 Periodic Review Confirming systems remain in a validated state on a defined, risk-based schedule.

SOP-QA-012 System Decommissioning Retiring systems in a controlled way while keeping records accessible for their retention period.

FORM-QA-004 Change Request Form Captures the change description, impact assessment, classification, approvals, and closure.

FORM-QA-006 Periodic Review Report Evidence-based review covering access, audit trails, change control, backup, incidents, and vendor status.

FORM-QA-014 Decommissioning Plan and Report Combined plan and completion report for retiring a GxP system, including record archival and QA sign-off.

Operational Pack

3 SOPs · 4 forms

The day-to-day controls that keep GxP systems running reliably, and a structured response when something goes wrong — including the logs and reports to prove it. Includes the Master Document List register.

7 documents included

SOP-IT-002 Backup and Recovery Backup frequency, restore testing, and recovery procedures for GxP data and systems.

SOP-QA-007 Training Role-based training requirements and records for GxP computerised systems.

SOP-QA-008 Incident and Deviation Management Classifying, investigating, and closing out incidents and deviations.

FORM-IT-003 Backup Log Ongoing log of backup completions, types, and outcomes for each GxP system.

FORM-IT-004 Restore Test Record Documents each restore test with verification checks, RPO/RTO confirmation, and sign-off.

FORM-QA-007 Individual Training Record Per-person log of training completed, method, and confirmation by trainer or line manager.

FORM-QA-008 Incident / Deviation Report Full incident lifecycle: description, impact, root cause, CAPA actions, and QA closure.

Preview

SOP-QA-004 — Change Control for GxP Computerised Systems

Pricing

Every pack is a one-time purchase with instant delivery. Mix and match, or save with the complete suite.

Foundation

4 SOPs · 1 policy · 3 forms · 1 register · 1 schedule

$249

Buy pack

21 CFR Part 11

3 SOPs · 1 policy · 5 forms

$229

Buy pack

CSV Core

4 SOPs · 3 forms

$229

Buy pack

Operational

3 SOPs · 4 forms

$189

Buy pack

Best Value

Complete suite

All 14 SOPs, 2 policies, 15 forms, 2 registers, 1 schedule, and a Customization Checklist

Everything above in one purchase — the full governance, compliance, validation, and operational framework for GxP computerised systems, with every matching form, register, and schedule included.

$699

Save $197 vs. individual packs

Buy pack

Frequently asked questions

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?

14 SOPs, 2 policies, 15 matching forms, 2 registers, and 1 schedule — 34 editable Microsoft Word (.docx) files in total — along with a Customization Checklist. The Master Document List register is included with every individual pack. Delivered as an instant download after checkout. No physical product, no account required.

Are Validation Plan and Validation Summary Report templates included?

No. SOP-QA-003 (Computer System Validation) defines the validation lifecycle and specifies what the Validation Plan and Validation Summary Report must each contain, but the templates themselves are not supplied. Their content varies with system type, GAMP 5 category, and regulatory scope, so they are developed by your organisation. The included Customization Checklist flags this too.

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.

Private Preview

A complete GxP quality framework, built for 21 CFR Part 11 and EU Annex 11.

About Us

Packs

Foundation Pack

Compliance Pack

CSV Core Pack

Operational Pack

Preview

Pricing

Foundation

21 CFR Part 11

CSV Core

Operational

All 14 SOPs, 2 policies, 15 forms, 2 registers, 1 schedule, and a Customization Checklist

Frequently asked questions