Worldover, AI operating system for substance-based businesses

    Supplements · QMS

    QMS for supplement manufacturers

    Today

    A batch is finished, boxed and blocking a bay while someone works out which results are still outstanding.

    Document-led quality systems store the certificate. They don't know which formulation version, active batch or specification the result should be judged against, so release becomes a manual reconciliation.

    With Worldover

    Worldover QMS connects specifications, sampling plans, test results, certificates of analysis, deviations and CAPAs to the batch, the formulation version and the materials behind it.

    Release is a status anyone can see, with every outstanding test, signature and deviation listed against the batch.

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    The problem

    Why generic QMS failssupplements manufacturer teams.

    Certificates arrive as PDFs

    Supplier results are checked by eye against a specification held somewhere else, so a mismatch depends on who's reading.

    Deviations live apart from the product

    A deviation log tells you something happened, not which products, batches and customers it touches.

    Traceability is rebuilt on demand

    When a recall question lands, the chain from active batch to finished pallet is reassembled from several systems under time pressure.

    A working day

    A recall question on a Friday afternoon

    1. A supplier reports a heavy metal excursion on one lot of a botanical extract.

    2. Today: quality pulls goods-in records, blending sheets and dispatch notes to work out where that lot went.

    3. In Worldover: the material lot links forward to every blend, batch, pallet and customer delivery.

    4. Retained samples, test results and release decisions for each affected batch are already attached.

    5. The customer notification list and the evidence pack are produced from the record rather than assembled by hand.

    How it runs

    How QMS worksinside Worldover.

    01

    Specifications come from the approved version

    Release criteria are derived from the formulation version being made, not from a separate quality document.

    02

    Results land against the batch

    In-house and third-party results, certificates and micro data attach to the batch and the material lot they judge.

    03

    Deviations carry their impact

    Every deviation shows the batches, products and customers involved, with the CAPA tracked to close.

    04

    Release is explicit

    Outstanding tests, signatures and open deviations are visible, so nothing is released on assumption.

    What's in it

    The detail behindQMS.

    FDA 21 CFR Part 11FDA 21 CFR Part 111

    Testing Management

    Test protocols, scheduling, results and approvals with full audit trail.

    • Test protocol library

      Pre-built and customisable protocols (stability, compatibility, microbial and others) with configurable parameters and pass/fail criteria.

    • Test scheduling

      Schedule tests against formulations, raw materials and finished products, with status tracking and automated reminders.

    • Results management

      Record and approve results with a full audit trail, linked back to formulations, products and batches.

    • Approval workflows

      Configurable approvals with role-based sign-off.

    • Test reporting

      Reports for internal QA and external regulatory submission.

    • Integration with formulation and PLM

      Results feed release decisions and regulatory documentation directly.

    QMS

    Training, document control and CAPA. Supports FDA 21 CFR Part 11.

    • Training

      Monitor training for individuals and the team as a whole as the operation scales.

    • Auto-reminders

      Automatic reminders for outstanding training items.

    • Document control

      Change management across SOPs, batch documentation, training records and health and safety, with 21 CFR Part 11 electronic records and a full audit trail.

    • CAPA reporting

      Customisable CAPA covering corrective and preventive actions, deviations and change control, supporting 21 CFR Part 111 record-keeping.

    The difference

    Why the substance recordmakes the difference.

    Because material lots, potency and assay live on the substance record, quality judges a result against the version and lot it belongs to. That's what makes forward and backward traceability a query instead of a project.

    Better together

    What changes when QMSshares a record with the rest of your setup.

    QMS + PLM

    Specifications and release criteria come from the approved formulation version.

    Explore PLM

    QMS + MRP

    Blocked and quarantined stock is reflected in planning instead of discovered on the floor.

    Explore MRP

    QMS + ERP

    Released stock becomes sellable stock without a manual status update.

    Explore ERP

    Willow

    What teams actually askonce the record is in one place.

    • Which batches can't be released today, and what's outstanding on each?
    • Where did this active lot end up, down to customer delivery?
    • Which deviations on this product line are still open after 30 days?

    Willow doesn't replace expert judgment. It removes the searching, re-keying and chasing between the systems that hold your answers.

    Request a demo

    We'll walk through your current workflow, then show the same workflow running on one record.

    Request a demoBack to supplements manufacturer software
    Supplement manufacturer softwarePLM for supplement manufacturers

    Research

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