Worldover, AI operating system for substance-based businesses

    Cosmetics · QMS

    QMS for cosmetic manufacturers

    Today

    Batch release waits on paperwork that exists, but is in three systems, and an audit means a fortnight of assembling evidence you already produced.

    A document-control QMS controls documents. It doesn't know the formula version, the raw material lot or the customer specification the batch was made against, so every quality decision starts with a reconciliation.

    With Worldover

    Worldover QMS connects specifications, in-process checks, raw material lots, deviations, CAPA and certificates of analysis to the approved formula version and the batch record.

    Batches release on evidence rather than on chasing, and an audit or customer questionnaire is answered from the record instead of rebuilt.

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    The problem

    Why generic QMS failscosmetics manufacturer teams.

    Release criteria are copied by hand

    When specifications live in a document system, they're re-keyed into batch sheets, and the two drift apart silently.

    Deviations lose their context

    A deviation logged as free text can't be grouped by raw material, supplier lot or line, so recurring causes stay invisible.

    Customer-specific requirements are invisible

    Contract manufacturing means each customer has their own release pack, retention rules and testing expectations. Generic QMS treats them as attachments.

    A working day

    A Friday afternoon batch release

    1. A batch is complete and the customer expects dispatch on Monday.

    2. Today: QA checks the batch sheet against a specification PDF, waits for a lab result by email, and hunts for the raw material certificate of analysis.

    3. In Worldover: the batch shows its formula version, every material lot consumed, the in-process checks completed and the two results still outstanding.

    4. The outstanding lab result posts against the batch, the release criteria evaluate automatically, and QA signs once.

    5. The customer release pack, including certificates, test results and traceability, is generated from the record.

    How it runs

    How QMS worksinside Worldover.

    01

    Specifications come from the approved version

    Release criteria are inherited from the formula and customer agreement, never retyped.

    02

    Checks are captured where the work happens

    In-process checks, weights and equipment records attach to the batch as it runs.

    03

    Deviations connect to their cause

    Every deviation references the material lot, supplier, line and product, so trends are countable.

    04

    Release and evidence are one action

    Sign-off produces the traceability pack, so an audit request is an export rather than a project.

    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.

    When quality runs on the substance record, a supplier lot problem is traceable in both directions in one step: which batches used it, and which customers received them. That's the difference between a contained investigation and a precautionary recall.

    Better together

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

    QMS + PLM

    Release criteria stay tied to the approved formula version and its customer sign-off.

    Explore PLM

    QMS + MRP

    Quarantined and released stock reflect quality status in real time, so planning doesn't commit blocked material.

    Explore MRP

    QMS + ERP

    Dispatch and invoicing wait on genuine release status rather than a verbal confirmation.

    Explore ERP

    Willow

    What teams actually askonce the record is in one place.

    • Which batches used supplier lot 4471, and which customers received them?
    • Summarise every deviation on this product line in the last six months and group them by cause.
    • Build the release pack for batch 20418, including certificates of analysis for each material lot.

    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 cosmetics manufacturer software
    Cosmetics manufacturer softwareGuide: electronic batch records in cosmeticsWorldover vs MasterControl

    Research

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    If you're still building a shortlist, these break the market down side by side.