Quality Commercial
SQH Documents & quality system
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
Documents & quality system
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
- 01 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.
- 02 Signs each step electronically and writes it to a hash-chained audit trail: a record can be superseded, never silently altered.
- 03 Keeps the competency matrix live: who is qualified on which version of which procedure, and what falls out of date when a document changes.
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 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.
Key capabilities
SQH
- 01
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.
- 02
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.
- 03
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.
- 04
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.
- 05
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.
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
Talk to us
Talk about SQH
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.