Worldover, AI operating system for substance-based businesses

    Cosmetics · QMS

    QMS for cosmetic manufacturers

    QMS for cosmetic manufacturers. Specifications, in-process checks, deviations, CAPA and batch release run on the same product record as the formula, so ISO 22716 evidence is a by-product of the work.

    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.

    What's in it

    What QMSdoes inside Worldover.

    The operational outcomes come first. Open any area to inspect the underlying controls, records and technical detail.

    Standards and regimes

    FDA 21 CFR Part 11FDA 21 CFR Part 111
    01Testing ManagementTest 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.

    02QMSTraining, 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.

    One workflow, end to end

    A Friday afternoon batch release

    The difference isn't another isolated tool. It's the same work running from one live record.

    Where work breaks

    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.

    1. 01

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

    2. 02

      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. 03

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

    4. 04

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

    5. 05

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

    With Worldover

    1. 1

      Specifications come from the approved version

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

    2. 2

      Checks are captured where the work happens

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

    3. 3

      Deviations connect to their cause

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

    4. 4

      Release and evidence are one action

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

    Willow

    Useful AI starts with live operational context.

    Scoped permissions, human approval for anything material and a full audit trail of every action.

    • 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.

    Buyer confidence

    A specialist system, without a specialist-system rollout.

    Worldover combines detailed operational control with a practical route to a live first phase.

    50+
    Enterprise customers across cosmetics, chemicals and supplements
    4 to 7
    Point systems typically retired, most within 6 months of go-live
    12 to 16 weeks
    To a live Phase 1, not a multi-year programme
    1 record
    Per substance, everywhere it appears

    See it on your operation

    Book a 30-minute slot

    Give us the essentials, then choose a 30-minute slot directly in the right person’s calendar. We’ll use your workflow, products and documents, not a generic slide deck.

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