End-to-end EU GMP QMS implementations, customized to your company.
We build and run your quality system with you — your SOPs, your roles, your processes — on an eQMS designed GACP-to-GMP native for cultivation and manufacturing operations, with the validation evidence to stand behind it.
A quality system that arrives working — because we implement it with you.
Most eQMS projects hand you an empty shell and a login. We deliver the other way around: an implementation service with the product inside it.
Discover
We map your processes, document inventory, org roles, and regulatory scope — GACP through GMP.
Configure
Your SOP set, workflows, roles, and training matrix are configured into the system as controlled records — configuration, not custom code.
Validate
We support your Annex 11 / GAMP 5 validation with a vendor evidence package generated from the system itself.
Go live
Your SOPs effective, roles mapped, training assigned, and a full deviation-to-CAPA cycle proven on your own data.
One system of record, from the grow room to the quality office.
Built mobile- and offline-first for the places quality work actually happens — shared tablets, gloved hands, interrupted shifts — not just a desk in the quality office.
Document control
Controlled documents — SOPs, specifications, forms, protocols — with full lifecycle from draft through effective to superseded, and periodic review schedules.
Training records
Role-based curricula, assignments, and qualification state. A new effective document version automatically raises retraining.
Deviations & OOS
Deviation reports and out-of-specification investigations, from capture through disposition and closure.
CAPA
Corrective and preventive actions with effectiveness checks — deviations spawn CAPAs in one connected workflow.
Change control
Structured change reason and impact assessment ship with document revisions today; the full standalone change-control workflow is on the roadmap.
Batch records & EM
Executed batch records with e-signature per critical step, and environmental monitoring with excursion handling.
Equipment & calibration
Equipment register, calibration and maintenance schedules, and out-of-tolerance assessments.
Supplier qualification
Supplier assessments, the approved-supplier list, and requalification schedules.
A validation-support package generated from the architecture — not authored after it.
Under Annex 11 and GAMP 5 you must validate your quality system for its intended use. Truth QMS is designed as a GAMP 5 category 4 configured product, and our job is to make your validation inexpensive and defensible.
- Traceability you can hand an auditor Requirements live in the system as structured URS/FS/DS records; the traceability matrix is generated from them and the test suite — never hand-maintained.
- Executable test evidence Tests are named by requirement. A suite run emits an evidence bundle — suite output, traceability matrix, build identity, environment manifest — so your OQ largely becomes executing the vendor's evidence run on your instance and countersigning it.
- Append-only audit trail, by construction Every record change is an append-only, hash-chained event with attributable e-signatures carrying signer, time, and meaning — the ALCOA+ principles enforced in the data layer, not policy documents.
- Audit-trail design rationale, in writing A standing vendor document explains append-only enforcement, hash chains, e-signature semantics, the correction model, and retention — the document you hand an inspector who asks how the system ensures data integrity, aligned with EU GMP Annex 11 and PIC/S PI 041 expectations.
- Supplier-assessment answers, ready A prepared answer pack for GAMP 5 supplier-audit categories, citing the system's real mechanisms.
“Would a new hire on their second day, wearing gloves, understand what to do next without asking anyone?”
The design floor for every operator screen. Compliance machinery should read as care for the work — one task at a time, in plain language, with almost no typing — while the record underneath stays inspection-grade.
See it working — on your processes, not ours.
We will walk you through the system live, mapped to your own documents, roles, and workflows — and show you exactly what your validation package would look like.
Talk to us about your implementation.
Whether you are retrofitting GMP onto a working cultivation operation or standing up a new manufacturing line, we scope every implementation individually.
Tell us where you are in your GMP journey and we will come back with a concrete next step.
admin@truthqms.comWhat happens next
A short scoping call, then a live walkthrough of the system mapped to your own processes — no slideware, the working application.
Request a walkthrough