# SQH — Documents & quality system

> Controlled documents, training, deviations, CAPA and change control on one process engine, with e-signature and a hash-chained audit trail.

- Where it stands: Commercial
- Quality · Synlogica
- Canonical: https://synlogica.ai/applications/sqh/
- Language: en-US

SQH is a document and quality management system for GxP: controlled documents and versions, training and the competency matrix, deviations, CAPA, change control, internal audits, risk and management review — one process engine underneath, with e-signature and an audit trail that cannot be edited after the fact.

## The problem

Most quality systems grow as a set of tools that do not know about each other: documents in one place, training records in another, deviations in a spreadsheet, CAPA in email. Every link between them is a person remembering to make it, and every inspection starts by reconstructing those links by hand.

## What it does

1. Runs every quality process — document control, training, deviation, CAPA, change, audit, risk — on the same workflow engine, so a deviation can open a CAPA that changes a document that retrains its readers, with the chain recorded.
2. Signs each step electronically and writes it to a hash-chained audit trail: a record can be superseded, never silently altered.
3. Keeps the competency matrix live: who is qualified on which version of which procedure, and what falls out of date when a document changes.

## Key capabilities

- **One process engine under every record** — Versioned workflow definitions, quorum and parallel approvals, exit guards with justified refusals and a PDF manifest — the same engine runs documents, deviations, CAPA and change control.
- **Controlled documents end to end** — Periodic review, expiry, full-text search under need-to-know, watermarked read-only renditions with RFC 3161 timestamps, a controlled-copy register, redline diff between revisions and release packages.
- **Training gate before a document takes effect** — Training obligations derive from the document matrix; a new revision cannot become effective until the required readers are trained.
- **Quality events and compliance** — Deviations, CAPA, change control, complaints, internal audits with an external-auditor portal, supplier qualification, risk register with FMEA and RCA, management review.
- **Audit trail you can verify** — Hash-chained, append-only entries with a verification endpoint and CSV export; electronic signatures on every controlled step; a validation package with a requirement-to-test traceability matrix.

## Who it is for

Quality units in pharmaceutical manufacturing, wholesale distribution and contract laboratories that need a full QMS on their own tenant rather than a module-by-module licence. Built as a parity project against the established enterprise vaults.

## Where it stands

Commercial — available under licence today. Onboarding starts with a working session on your own data, where the configuration baseline and the shared-responsibility split are agreed before anything goes live.

## The same foundation as every Synlogica application

Every application in the portfolio carries the same controls, so an inspector who has seen one knows how to read the next.

- Versioned records — a record can be superseded, never silently altered.
- Electronic signature on every controlled step.
- An audit trail an inspector can follow, hash-chained end to end.
- Runs on your own tenant, hosted in the EU.

## Read more

- [21 CFR Part 11 vs EU GMP Annex 11: electronic-records requirements side by side](https://synlogica.ai/resources/21-cfr-part-11-vs-annex-11/)
- [GAMP 5 Category 4 vs Category 5: what your software vendor must prove](https://synlogica.ai/resources/gamp-5-category-4-vs-5/)

## Talk to us

Bring a real case — a recent excursion, an invoice you doubted, a procedure that just changed — and we walk it through together. If it is not a problem for software, we will say so.

- Book a 30-minute call: https://calendly.com/adam-karpinski-synlogica/30min
- Email: adam.karpinski@synlogica.ai
- Privacy Policy: https://synlogica.ai/privacy/