Controlled·Copy
Pricing

GxP Computerised Systems · SOP Template Suite

A complete GxP computerised systems SOP suite, built for 21 CFR Part 11, EU Annex 11 and ICH E6(R3).

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 — $799 Browse all 42 documents

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

16
SOPs & Policies
15
Ready-to-use Forms
21 CFR
Part 11 Aligned
GAMP 5
Aligned

About

Controlled Copy is written by Renos, a Chief Information Officer at a clinical research organisation, with over a decade of hands-on experience overseeing GxP computerised systems, validation programmes, and quality management infrastructure across 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 42-document SOP suite from scratch is typically weeks of work — before you've adapted a single template to your organisation.

Controlled·Copy

$799

All 14 SOPs, 2 policies, 4 validation templates, 17 matching forms, 4 registers, and 1 schedule, already cross-referenced and aligned to 21 CFR Part 11, EU Annex 11, ICH E6(R3), 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, templates, 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 · 4 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.

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.
FORM-QA-009 Vendor Assessment Questionnaire Thirty questions covering a vendor’s quality system, development and validation practices, data integrity, security, hosting, and exit terms — with the QA outcome and any conditions of approval.
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.

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 · 4 templates · 3 forms

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

SOP-QA-003 Computer System Validation A GAMP 5-aligned lifecycle approach, from Validation Plan to Validation Summary Report — with all four validation templates supplied in this pack.
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.
TMP-QA-001 Validation Plan Scope, approach, deliverables, roles, acceptance criteria, and schedule for validating one system, scaled to its GAMP 5 category and risk classification.
TMP-QA-002 User Requirements Specification Requirement tables by category, pre-filled with thirteen worked 21 CFR Part 11 and Annex 11 requirements traced to their clause and flagged GxP-critical.
TMP-QA-003 Validation Protocol and Test Script One copy per IQ, OQ, and PQ/UAT phase — test conventions, repeatable test-case blocks with a worked example, deviation log, and approval before and after execution.
TMP-QA-004 Validation Summary Report Activity summary, requirements traceability matrix, deviations, open items, and the release conclusion QA approves before the system is used.
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 · 5 forms · 2 registers

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

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-IT-005 Business Continuity Arrangement Record The fallback a GxP process runs on while its system is down — when it is invoked, who authorises it, how data is reconciled afterwards, and the record of each test.
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.
REG-QA-003 Training Curriculum Matrix Roles against training items, pre-filled for every SOP and policy in the suite, marking read-and-understood, instructor-led, or competency assessment.
REG-QA-004 Incident and Deviation Log Central log of reported incidents and deviations with severity, status, and a trending summary for periodic and management review.

Preview

SOP-QA-004 — Change Control for 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 · 4 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 · 4 templates · 3 forms

$349

Buy pack

Operational

3 SOPs · 5 forms · 2 registers

$189

Buy pack
Best Value

Complete suite

All 14 SOPs, 2 policies, 4 validation templates, 17 forms, 4 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 validation template, matching form, register, and schedule included.

$799
Save $217 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, 4 validation templates, 17 matching forms, 4 registers, and 1 schedule — 42 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?

Yes. The CSV Core pack includes four validation templates — Validation Plan (TMP-QA-001), User Requirements Specification (TMP-QA-002), Validation Protocol and Test Script (TMP-QA-003), and Validation Summary Report (TMP-QA-004), which carries the requirements traceability matrix. They follow the lifecycle defined in SOP-QA-003 and are structured for customisation to your system's type, GAMP 5 category, and regulatory scope, like every other document in the suite.

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 E6(R3) and other 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.

Can I get a refund?

Because the files are delivered instantly and can’t be returned, all sales are final and we don’t offer refunds. If a file is damaged or you have trouble downloading it, contact info@controlledcopy.com and we’ll sort it out.

What if I have a question after buying?

Reach out to us at info@controlledcopy.com and we'll get back to you.