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Solution · Cannabis & medicinal plants (GACP)

GACP and GMP from cultivation to release, fully traceable

For growers and processors of medical cannabis and medicinal plants: vemix controls your SOPs, qualifies your team, runs deviations, CAPA and changes as signed records and documents batches and testing electronically. Designed for GACP and EU GMP, with electronic signatures that support the requirements of 21 CFR Part 11 and EU GMP Annex 11.

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  • GACP and EU GMP standard package
  • Controlled SOPs as sealed PDF/A
  • Deviation, CAPA and change control
  • Electronic batch record
  • Time-limited inspector access
The challenge

Where GACP operations hit their limits

  • Cultivation under GMP scrutiny

    From starting material to dried product, every step must be traceable. Paper records and spreadsheets rarely keep pace with growth.

  • High expectations from authorities and buyers

    Inspections, supplier audits by your customers and quality agreements demand robust evidence, often at short notice.

  • Many silos, no continuous trail

    SOPs in a file share, training on paper, deviations by email: at inspection, the link between event, cause, action and training is missing.

Quality management

One QM system for GACP and GMP operations

The GACP standard package ships with preconfigured document types, workflows and templates based on EMA GACP and EU GMP Annex 7, plus a compliance matrix that maps clause numbers to the evidence in the system.

  • Controlled SOPs

    Revisions with an approval workflow: authoring, subject-matter review, approval, QA release. An SOP only becomes effective with its sealed PDF/A rendition; supersession, withdrawal and periodic review are signed steps.

  • Electronic signatures with signature meaning

    Every signature carries name, time and meaning, such as "QA release" or "verified (second person)". Re-authentication at signing (password, optionally TOTP), lockout after failed attempts and a hash-chained audit trail support the requirements of 21 CFR Part 11 and EU GMP Annex 11.

  • Deviation, CAPA and change control

    Deviations with classification, root cause analysis (5 Whys, Ishikawa) and batch hold; CAPA with effectiveness checks; change control with an impact assessment of which SOPs, forms and training are affected.

  • Training and qualification lock

    Training assignments, knowledge tests and on-the-job assessments. The qualification lock ensures only trained people perform a step.

  • Batch records and testing

    Electronic batch record (eBR), QC test records with OOS/OOT handling, supplier evaluation and equipment management with calibration and maintenance.

  • Inspector access and WORM

    Authorities or auditors get a time-limited read-only role. Approved documents and evidence are kept in WORM storage whose retention can only be extended, never shortened.

From cultivation to release

  1. 01
    Control SOPs
    Instructions for cultivation, harvest, drying and storage are written in the structured editor or as Word files from a controlled template and go through signed approval.
  2. 02
    Qualify the team
    New revisions trigger training. Only trained people may perform the affected step.
  3. 03
    Document the batch
    Batch record and testing run electronically; deviations are reported with photos and can place the batch on hold.
  4. 04
    Release and open for inspection
    QA release by electronic signature. For inspections, the authority receives time-limited, read-only access.
Standards

Designed for GACP and EU GMP

The GACP standard package combines the EMA guideline on good agricultural and collection practice with Annex 7 of the EU GMP guide; for processing, the GMP standard package is also available. You achieve compliance through validation, your own SOPs and training. vemix provides the validation package and OQ test reports for every release.

  • EMA GACPGood agricultural and collection practice for starting materials of herbal origin
  • EU GMP Annex 7Manufacture of herbal medicinal products
  • EU GMP Annex 11Computerised systems: requirements supported
  • 21 CFR Part 11Electronic records and signatures: requirements supported
  • GAMP 5 · Cat. 4Validation package with URS template, risk assessment and traceability matrix

Relevant modules

Quality management
Controlled documents, training, deviations and CAPA, with Part 11 signatures and an audit trail.
Digital signatures
Sign NDAs and contracts electronically, with a timestamp.
Contracts
Deadlines under control, clauses detected by AI.
CRM
Contacts, companies and deals in one pipeline.
Projects
Planning with Gantt, project controlling and capacity per calendar week.
FAQ

Frequently asked questions

How do I validate vemix for GMP use?
You validate vemix for your intended use. vemix provides a GAMP 5 (category 4) validation package with a URS template, risk assessment and traceability matrix, plus OQ test reports for every release. New releases are announced at least 30 days in advance and enabled per workspace, so your validated state is preserved.
How do authorities or auditors get access?
Assign the QM inspector role with an expiry date ("access until"). Access is read-only and clearly marked "Inspection · read only"; every document view is logged.
Can I keep using existing SOPs in Word?
Yes. Alongside the structured web editor, you can work file-based: Word, Excel or PowerPoint from a controlled template, with check-out/check-in and editing straight from your file explorer via the WebDAV drive. Optional AI assistance can suggest an SOP draft from a legacy document. The draft is marked as an AI suggestion, and signatures always come from people.
Does vemix also cover processing under EU GMP?
Yes. Alongside the GACP standard package, the GMP standard package (EU GMP guide and 21 CFR 210/211) is available. Batch records, QC test records with OOS/OOT, supplier evaluation and equipment management are included.
How long is evidence retained?
Approved documents and evidence are kept in WORM storage; retention can only be extended, never shortened. Destruction happens only after the retention period and with signed approval, and a legal hold retains data when needed. At contract end you receive a full export.

Go into your next inspection with complete records

See in a live demo how vemix brings SOPs, training, deviations, CAPA and batch documentation together for GACP and GMP operations.

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