Open Source GxP Templates50 URS + 50 FS
A free, openly-licensed reference corpus covering the regulated pharma / biotech system landscape — from compendial instruments to AI/ML platforms, enterprise quality systems, clinical-trial systems, and shared IT infrastructure. Anchored in primary regulatory sources. Released under CC-BY-SA 4.0.
Get the corpus
Free, ungated. CC-BY-SA 4.0. One zip, everything inside.
Not a regulated record
Every file carries do_not_use_as: regulated_record. Companies, dates, and identifiers are marked (synthetic). No FDA, EMA, BfArM, Swissmedic, or other competent authority has reviewed this material. If you derive an operational artefact from it, your Quality Unit must review, edit, sign, and approve it under your own change-control before it has any regulated status.
Want updates when new templates land?
A short note every few months when we ship a new corpus version or a regulatory-update revision. Nothing else.
What's inside the zip
Two mirrored subtrees — URS and paired FS — plus the canonical methodology, evaluation rubric, changelog, and known-limitations files.
50 User Requirements Specifications
Single canonical structure: § 1 Purpose → § 9 References. Every requirement carries ID + Priority (H/M/L) + Risk class (R1/R2/R3) + verifiable shall-clause. FS-namespace-independent — traceability lives exclusively in the paired FS. From v1.3 every URS declares its Project Mode (config-on-COTS, custom-build, infrastructure-qualification, or instrument-configuration) in the Document Control block.
50 Functional Specifications
Paired one-to-one with the URS. Architecture, component decomposition, per-FS-ID rows citing originating URS-IDs, interface specs, non-functional behaviour, the URS → FS Traceability Matrix (every URS-ID gets its own row, no range compression), and — new in v1.3 — an Implementation Risk Register as the final numbered section (implementation-level risks live in the FS, not the URS).
Methodology, rubric, changelog
METHODOLOGY § 2A is the canonical rule-set (citation currency, Part 11 sub-section map, ICH M10 map, EU MDR PSUR cadence, DACH authority map, URS↔FS traceability rules, EU AI Act Annex I vs III, Project Mode declaration, FS Implementation Risk Register). Evaluation rubric, full v1.0→v1.3 changelog, and known limitations included.
Coverage
Depth is sized to real-world system complexity. Four tiers, from small standalone instruments to mission-critical AI/ML platforms.
| Tier | Class | Target reqs | Examples |
|---|---|---|---|
| T1 | Small / standalone instruments + utilities | 30–50 | Karl Fischer, particle counter, compendial calculator |
| T2 | Configured lab instruments + mid-complexity apps | 50–80 | UV-Vis, NIR, TOC, dissolution, SPC, stability, APR, LMS, autoclave, cold chain, EMS, BMS |
| T3 | Large enterprise + production systems | 100–150 | LIMS, ELN, EDMS, eQMS, RIM, RTRT, SCADA, AD, audit-trail workbench, CV inspection |
| T4 | Mission-critical / multi-module | 150–250 | EDC, CTMS, eTMF, Vault Submissions, AI/ML Model Server, GenAI LLM Service, MES PAS-X, PV DB |
Lab instrumentation & analytics
Chromatography, LC-MS, UV-Vis, NIR, TOC, dissolution, stability, SPC, APR, particle counter, Karl Fischer
Production & process control
MES PAS-X, SCADA water systems, bioreactor / continuous fermentation, tablet coater, autoclave, lyophilizer, cold chain
Enterprise quality
LIMS, ELN, EDMS, eQMS, ValGenesis VLM, Watson LIMS, RIM, RTRT, Annual Product Review
Clinical trials
EDC, CTMS, eTMF, Vault Submissions, ePRO portal, LMS, randomisation, study build
Post-market & safety
Pharmacovigilance DB (Argus), EU MDR PMS, Adverse Event DB, Submissions drafting
AI / ML / Custom Cat-5
AI/ML Model Server, GenAI LLM Service, CV Inspection (sterile products), audit-trail workbench
Shared IT infrastructure
Active Directory identity service, Backup tier (T1/T2/T3, RPO/RTO targets)
Six verification gates — all green
Every release passes a fixed set of structural + citation checks before it ships. v1.3 (2026-05-13) cleared all six.
How to cite
Licensed under Creative Commons Attribution-ShareAlike 4.0 International (CC-BY-SA 4.0). Full CITATION.cff metadata included in the zip.
Attia, N. GAMP 5 Synthetic URS+FS Corpus, v1.3 (2026). NA IT Consulting (Neural Architects), Sandhausen, Germany. Licensed CC-BY-SA 4.0.
Frequently asked questions
Related services
The corpus is reference material. If you need help applying it to a real validation programme, we offer:
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