Compliance Frameworks & Document Store

Stop writing compliance docs from scratch.

Download battle-tested URS templates, 21 CFR Part 11 checklists, and GAMP 5 validation frameworks — built by pharmaceutical IT/OT engineers for engineers.

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MEETING GLOBAL LIFE SCIENCE REGULATORY STANDARDS
FDA 21 CFR Part 11
EU Annex 11
GAMP 5
ALCOA+
IEC 62443
The Store

Standardized GxP Templates.

URS-SCADA-HMI-001

URS — SCADA & HMI Systems

  • Functional requirements — alarms, historian, data acquisition
  • 21 CFR Part 11 checklist mapped to §11.10(c)(d)(e)(k)
  • Electronic signatures (§11.50 / §11.70 / §11.100)
  • Validation phases: DQ / IQ / OQ / PQ
  • Bilingual: English + Spanish
Word .docx · PDF Preview · Instant Download
$49 USD
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URS-LAB-EQUIP-001

URS — Lab Instrument Integration

  • Connectivity: RS-232, USB, TCP/IP, OPC-UA
  • Full ALCOA+ mapping — all 9 attributes
  • LabX (Mettler Toledo) specific requirements
  • OpenLab CDS / Empower specific requirements
  • Calibration per USP <1058> / ISO 17025
Word .docx · PDF Preview · Instant Download
$49 USD
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CHK-OT-CFR11-001

21 CFR Part 11 Audit Checklist

  • 80-item checklist for WinCC, FactoryTalk, AVEVA, Ignition environments
  • Comprehensive technical control assessment
  • Procedural requirement gap analysis
  • Evidence gathering guide included
Waitlist Active · Coming Soon
$39 USD
Methodology

From download to compliant document in minutes.

1

Purchase & download

Instant .docx delivery via secure Lemon Squeezy checkout. No account required.

2

Fill in your [brackets]

Every field requiring customization is clearly marked. Replace site name, equipment IDs, dates, and responsible parties.

3

Submit for QA review

Your document is structurally complete, regulation-mapped, and ready for your organization's review and approval workflow.

Authoritative Origin

Built by an engineer. Not a copywriter.

These templates were built in real pharmaceutical manufacturing environments — systems managing production lines, analytical laboratories, and validation workflows under active FDA and EU GMP scrutiny.

Every requirement is cross-referenced to its regulatory source. Every checklist item has been verified against live audit scenarios. The goal is simple: give you a document you can defend.

10+ years pharma IT/OT experience
Compliance 21 CFR · EU Annex 11
4 countries GxP environments
GxP Template Preview - URS SCADA HMI
Inclusions

Everything a compliance document needs.

Nothing it doesn't.

Bilingual — English + Spanish throughout
21 CFR Part 11 mapped — every req cross-referenced to §
ALCOA+ coverage — all 9 data integrity attributes
Validation-ready — DQ/IQ/OQ/PQ traceability built in
Word .docx format — edit, brand, submit as your own
PDF preview included — see before you buy
Instant download — no account required
Lemon Squeezy checkout — VAT handled automatically
Support Center

Common questions.

Are these templates validated?
No — templates are not validated documents. They are professional starting points that must be reviewed, customized, and formally approved by your organization per your internal SOPs and GAMP 5 risk classification. Validation responsibility remains with the purchasing organization.
Can I use these in an FDA inspection?
These are framework documents designed to align with FDA 21 CFR Part 11 requirements. Your QA team must review, complete, and formally approve any document before use in a regulated inspection context.
What formats are included?
Each template includes a fully editable Word (.docx) file and a read-only PDF preview. All fields requiring customization are marked with [BRACKETS].
Are templates available in Spanish?
All templates include bilingual fields (English/Spanish). Full Spanish-only editions are planned for a future release.
Do you offer custom template development?
Yes — contact us at hello@gxptemplates.com for custom URS, validation protocol, or audit checklist development for your specific systems and regulatory context.
Expert Review

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