Worldover, AI operating system for substance-based businesses

    Chemicals · QMS

    QMS for chemical manufacturers

    Today

    A customer reports an out-of-specification result, and tracing which raw material lots and which other customers are involved takes days of cross-referencing.

    Generic quality systems manage documents and audits. They don't hold the batch genealogy of blends made from blends, so a traceability question has to be reconstructed manually every time.

    With Worldover

    Worldover QMS connects specifications, sampling plans, test results, deviations, CAPA and certificates of analysis to the batch, its input lots and the shipments that left the site.

    Release decisions are evidenced, investigations are contained, and a recall question is answered in both directions in minutes.

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    The problem

    Why generic QMS failschemicals manufacturer teams.

    Blend genealogy is deeper than one level

    Intermediates made from intermediates defeat single-level lot tracking, which is what most systems actually implement.

    Certificates of analysis are typed, not generated

    Manual certificates introduce transcription errors into the one document the customer relies on.

    Deviations aren't connected to supply

    Without the supplier lot on the record, a recurring quality problem looks like operator variation.

    A working day

    An out-of-specification call

    1. A customer reports viscosity outside specification on a delivered lot.

    2. Today: quality pulls the batch sheet, works back through two intermediates, then asks the warehouse which other customers received related lots.

    3. In Worldover: the batch shows its full genealogy, every input lot, the test results at each stage and every shipment downstream.

    4. The investigation narrows to one supplier lot within the hour, and containment covers exactly the affected shipments.

    5. The CAPA links to the supplier record, so the next delivery is inspected against the known failure mode.

    How it runs

    How QMS worksinside Worldover.

    01

    Specifications live with the product

    Release criteria, methods and tolerances are inherited from the approved formula and customer agreement.

    02

    Testing posts to the batch

    In-process and finished goods results attach as they're produced, with retests and out-of-specification handling recorded.

    03

    Genealogy is captured automatically

    Every consumption event builds the multi-level batch tree, so tracing is a query rather than an investigation.

    04

    Certificates generate from results

    Customer certificates of analysis are produced from the actual test data, in the customer's required format.

    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.

    A blend is only as traceable as its inputs. Because Worldover holds substances and lots as first-class records, quality can move from a finished shipment back to a raw material lot, and forward again to every customer, without leaving the system.

    Better together

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

    QMS + Regulatory

    Release includes the market restrictions and document obligations for the destination.

    Explore Regulatory

    QMS + MRP

    Quality status governs what planning can commit, so blocked lots never enter a schedule.

    Explore MRP

    QMS + ERP

    Dispatch and invoicing follow real release, with certificates attached to the shipment.

    Explore ERP

    Willow

    What teams actually askonce the record is in one place.

    • Trace this shipment back to every raw material lot it contains.
    • Which customers received material derived from intermediate lot B-2287?
    • Group the last year of deviations on this product by supplier 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 chemicals manufacturer software
    Chemical manufacturer softwareWorldover vs ETQ RelianceGuide: chemical compliance for manufacturers

    Research

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