Control SOPs and forms, train your team and handle deviations, CAPA and change control in one system. Electronic signatures, a complete audit trail and sealed documents in WORM storage are part of it. The module supports the requirements of 21 CFR Part 11 and EU GMP Annex 11 and is designed for GMP, GACP, HACCP and ISO 9001.
A document only becomes effective once its sealed PDF/A rendition exists. You edit it in the web editor or in Word, Excel and PowerPoint as before.
Under 21 CFR § 11.200, with re-authentication and 18 signature meanings.
Append-only, anchored daily in three places, verifiable at the click of a button.
Only trained people can carry out a step, enforced automatically by the qualification lock.
Reported by smartphone, investigated with 5 Whys and Ishikawa, linked all the way to the change.
Preconfigured, with a compliance matrix and a validation package following GAMP 5 category 4.
Metadata, workflows and forms are fully configurable in the system. Every standard package comes with sensible examples that already reflect the regulatory requirements. Adopt them as a starting point or adapt them to your operation.
Every configuration change is versioned and released by signature, so the configuration itself stays auditable.
Every step is tied to linked records with a signature and an audit trail.
You start from a controlled template with mandatory sections. Edit it in the structured web editor with steps, warnings and parameters, or file-based in Word, Excel or PowerPoint with check-out/check-in.
The approval workflow runs from "Authored" to "QA release", in parallel or in sequence. Reviewers see changes as a block diff and comment directly; every signature requires re-authentication.
On approval, the database locks the revision. vemix creates a PDF/A rendition with an approval sheet, seals it, applies a timestamp and stores it in WORM storage.
The new revision goes to the recipient groups, for information or as training with minimum reading time, knowledge test, oral assessment or practical assessment. Reminders and escalation run automatically.
Numbered controlled copy, information copy or form with a serial number, always with a print reason. The QR code on every page shows whether the revision is still effective.
Anyone can report a deviation in the mobile app, even without a QM role. QA classifies it, sets an investigation deadline and blocks the batch if needed.
The linked CAPA is created from the investigation with one click. If a document has to change, the impact assessment shows which documents, forms and training are affected.
Loop: leads back to 01 Create the document when needed and starts a new revision.
Before closing, you review the record's audit trail and sign "Audit trail reviewed". Inspectors get read-only access with an expiry date.
There is no regulatory Part 11 certification for software. vemix provides the technical controls and the validation package following GAMP 5 category 4, with OQ test reports for every release.
No. There is no regulatory Part 11 certification for software. 21 CFR Part 11 and EU GMP Annex 11 are addressed to you as the regulated company: you validate the system for your intended use and operate it with your own SOPs and trained staff. vemix supports the requirements with the technical controls (electronic signatures under 21 CFR § 11.200, a hash-chained audit trail, WORM storage) and provides the validation package following GAMP 5 category 4 with a URS template, risk assessment, traceability matrix and OQ test reports for every release.
Yes. The Quality Management edition includes quality management without the CRM. You can add more modules such as the CRM, projects, contracts or signatures later without switching editions. Your QM data stays unchanged. Current prices are on the pricing page.
For GMP (EU GMP guidelines and 21 CFR 210/211), GACP (EMA GACP and EU GMP Annex 7, e.g. for medicinal plants and medical cannabis), HACCP (Codex Alimentarius principles, Regulation (EC) 852/2004), ISO 9001 and ISO 27001 with a statement of applicability. Each standard package comes with preconfigured document types, workflows and templates. A compliance matrix maps each clause number to the evidence in the system.
Yes. Alongside the structured web editor there is a file-based mode: Word, Excel and PowerPoint documents are created from a controlled template and edited via check-out/check-in, optionally right in the file explorer via the WebDAV drive in the "QM/My drafts" folder. Approval, sealing as PDF/A and training work exactly as in the web editor.
No. AI assistance can be switched off per workspace and is off by default. It suggests SOP drafts, change descriptions from the diff, test questions, root-cause analyses and impact assessments, and every suggestion is flagged as an "AI suggestion". If you accept one, the model name is recorded in the audit trail. The AI never signs and never triggers a workflow transition.
Through the QM inspector role: read-only access with an expiry date ("access until") and an "Inspection · read only" banner on every page. The inspector sees documents, records and the audit trail but cannot change anything. You can additionally export evidence such as the audit trail, training files or the qualification matrix as PDF/A.
In Scaleway data centres in France (EU), with a separate database for each company. Sealed documents, printed copies, attachments and audit trail anchors are kept in a dedicated WORM bucket with S3 Object Lock in compliance mode. Retention there can only be extended, never shortened. Once retention expires, destruction requires a signed approval, and at the end of the contract you receive a full export.
Every QM version comes with release notes and OQ test reports from more than 170 automated tests with requirement IDs. We announce changes at least 30 days in advance, and you activate new versions per workspace. That way you assess every change before it takes effect in your system.
Yes. In the mobile app at /m, anyone can report a deviation via the "Report" tab, with up to ten photos. Under "My reports" they see the status; QA is notified immediately and takes over classification and investigation.
Start with a standard package, bring your SOPs as Word files or in the web editor, and take your first revision through review, signature and training.
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