Worldover, AI operating system for substance-based businesses

    Chemicals · QMS

    QMS for chemical ingredient providers

    Today

    A customer flags a result outside their agreed specification, and confirming which batch, which site and which other customers received the same lot takes a day of phone calls.

    Generic quality systems assume one specification per product. You supply the same substance to many customers, each with their own agreed limits, sometimes tighter than your published range, and a complaint has to be checked against the right one.

    With Worldover

    Worldover QMS connects batch and lot records, customer-agreed specifications, complaints and corrective actions to the substance and site they concern.

    A complaint is checked against the correct specification immediately, and a shared root cause across customers is visible before it spreads further.

    The problem

    Why generic QMS failschemicals ingredient provider teams.

    Customer specifications sit in commercial files

    The agreed limit that actually governs a complaint is often not the published specification, and it isn't where quality looks first.

    Multi-site batches are hard to reconcile

    The same grade made at two sites needs its own batch history, and comparing them by hand is slow.

    Complaints aren't connected across accounts

    A shared lot supplied to several customers looks like separate incidents instead of one cause.

    A working day

    A specification complaint

    1. A customer reports a result they say breaches their agreed limit.

    2. Today: quality checks the published specification first, then discovers the customer's agreed limit is tighter, held in a sales file.

    3. In Worldover: the customer-agreed specification is already on the account and checked automatically against the batch result.

    4. The batch is confirmed as a genuine deviation against the customer's terms, not the published range.

    5. Other customers who received the same lot, and their own agreed limits, are checked in the same view.

    How it runs

    How QMS worksinside Worldover.

    01

    Batches carry full test results

    Results are held against the substance, grade and site, whichever site produced the batch.

    02

    Customer-agreed limits are on the record

    Where a customer's specification differs from the published range, it governs the check automatically.

    03

    Complaints link to batch, site and customer

    Shared lots and shared causes across customers are visible from one complaint.

    04

    Corrective actions are tracked to effect

    Actions attach to the substance and site, and their effectiveness is checked on the next batch.

    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 customer-agreed limits and batch history both sit on the substance record, a complaint is checked against the terms that actually apply, not the terms that are easiest to find.

    Willow

    What teams actually askonce the record is in one place.

    • Which other customers received the lot involved in this complaint?
    • Which customers hold a tighter agreed specification than our published range for this substance?
    • Summarise open corrective actions by site for this quarter.

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