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.
Every one of those is a record someone must own, sign, and stand behind in an inspection. Truth QMS carries all of them on one system of record — and we implement it with you, so it arrives already carrying your processes.
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 batch release.
Nine modules on one shared, tamper-evident record spine. One record model carries two regulatory classes — GACP and GMP, including Annex 7 herbal operations — so a vertical operation runs one QMS, not a farm system bolted to a pharma system. Built mobile- and offline-first for the places quality work actually happens: shared tablets, gloved hands, interrupted shifts.
Every controlled document lives one lifecycle: draft → in review → approved → effective → superseded, with periodic review schedules so nothing quietly goes stale.
Superseding is one attributed act: the approval that makes a new version effective retires its predecessor in the same signed step — no window where two versions are both "current".
Role-based curricula bind people to effective documents. When a new document version becomes effective, retraining is raised automatically for everyone whose role requires it.
Exams support image-based questions — glove-friendly, low-literacy-friendly — and qualification currency is derived live from the record and the clock, so a lapsed qualification surfaces in the overdue queues by itself.
An operator reports a problem in plain language, a few taps, right where it happened. QA gets a structured deviation with investigation, disposition, and closure — one workflow from the floor to the file.
Customer complaints and internal-audit findings enter through the same intake and feed the same investigation machinery, so every finding source ends in the same disciplined record.
Deviations spawn CAPAs in one connected workflow: proposed, approved, implemented — and then held open for an effectiveness check before anyone is allowed to call it closed.
A CAPA that changes a document routes through change control; the loop closes with evidence, not optimism.
Structured change requests carry priority classes and a risk block, an impact assessment, and an implementation plan — then approval, implementation, verification, and closure, each its own signed step.
Document revisions carry a structured change reason as well, so even the smallest change answers "why" on the record.
The master batch record is itself a controlled document, so it carries M1's full approval lifecycle. Execution runs against the effective MBR version, step by step, with an e-signature on every critical step — and only qualified people can execute a step.
Review and batch disposition — release or reject — is its own reviewed, signed act, with the batch's deviations, environmental excursions, and equipment state in front of the reviewer at the decision.
Monitoring points for grow rooms and cleanrooms, each with its sampling schedule and limits. An out-of-limit reading opens its excursion in the same recorded act — attributed to the person who recorded it, never orphaned.
Excursions run assessment to closure and can spawn deviations; readings feed the batch record, so release review sees the room the batch was made in.
Every instrument in one register with its calibration and maintenance schedules. Due and overdue are computed from the schedule and the clock — nobody has to remember to flag them.
Out-of-tolerance findings get a structured assessment, and a batch step can require an in-calibration instrument before it will accept a signature.
Qualification assessments, the approved-supplier list, and requalification schedules — with each supplier's risk tier at a glance on the register and the score itself one tap away, derived from the supplier's own audit, complaint, and CAPA history rather than hand-typed.
Supplier issues route to CAPA; a rating you can defend, because the record that produced it is one tap away.
One thread, floor to audit — because the modules share one spine.
Cross-module links aren't integrations, they're the architecture: every module writes the same append-only record spine, so a finding travels to its fix without ever leaving the system of record.
Reported on the floor
An operator logs a deviation in plain language, mid-shift.
Investigated
QA investigates and dispositions it, on the record.
Cause fixed
A CAPA implements the fix and holds for an effectiveness check.
Change & retraining
The SOP change routes through change control; retraining raises itself.
The audit passes
The whole thread is one traceable chain of signed records.
Risk register
An ICH Q9 risk register over the whole system — risks linked to the records that raise and retire them.
Management review
KPI and trend projections — open CAPAs, overdue training, deviation trends — with minuted, signed review meetings.
Internal audit
Audit schedules and findings, feeding the same investigation and CAPA machinery as every other finding source.
Shared quality calendar
Reviews, requalifications, calibrations, and audits on one calendar, drawn from the records themselves.
Electronic logbooks
Room, equipment, and area logbooks — contemporaneous entries with the same signature discipline as everything else.
In-context document viewer
The effective SOP opens in place, right where the work is — no leaving the task to hunt a PDF.
Overdue-first queues
Every record carries the same header — status, owner, due state — and anything overdue surfaces first, in red.
QA search
Faceted filters and saved searches across every module, built for the quality office's daily grind.
Why a regulator can trust these records.
Most systems ask an inspector to trust their database. Truth QMS makes tampering detectable instead — that's a stronger claim, and it's structural.
Hash-chained, append-only
Every record change is an append-only event stitched cryptographically to the one before. A torn-out page — or an edited one — is always detectable. Corrections are new signed events, never rewrites.
An external witness
The chain head is regularly anchored outside the system, so even a compromised administrator can't silently rewrite history. The audit trail isn't policy — it's physics.
Signatures that mean something
Each e-signature ceremony binds signer, time, and meaning — review, approval, witness — to the record it signs: the signature semantics EU GMP Annex 11 and 21 CFR Part 11 expect.
Where quality work actually happens.
Offline-first, rugged-tablet native
Capture keeps working through dead zones and interrupted shifts on shared, gloved-hand tablets — then reconciles to the record spine without losing attribution or order. Big targets, plain language, almost no typing.
Your brand, your vocabulary
Per-company skin packs re-express the whole system in your brand and your terms — "customized to your company" is the product, not a services invoice. Your operators see your quality system, not ours.
A validation package, generated
Structured URS/FS/DS traceability, executable test evidence, and a written audit-trail design rationale — generated from the architecture to support your Annex 11 / GAMP 5 validation. How the package works ->
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