Worldover, AI operating system for substance-based businesses

    Chemicals · QMS

    QMS for chemical brands

    Today

    A customer reports an out-of-specification delivery, and the batch record that would explain it's held by a manufacturer who hasn't replied yet.

    Quality systems assume you run the plant. A brand's quality work is oversight: approving manufacturers, holding them to an agreed specification, and connecting a customer complaint to a batch you didn't make.

    With Worldover

    Worldover QMS connects manufacturer approvals, agreed specifications, batch documentation, complaints and corrective actions to the products you sell.

    You see quality problems as patterns across manufacturers rather than isolated incidents, and a containment decision takes hours rather than a week of chasing.

    The problem

    Why generic QMS failschemical product owner teams.

    Batch records sit with the manufacturer

    When the evidence belongs to someone else, every investigation starts with a request and a wait, and the wait is worse the more manufacturers you use.

    Complaints are handled in customer service

    Without linking to the manufacturer and batch, a recurring specification issue looks like a series of unrelated unhappy customers.

    Manufacturer approval is a one-off audit

    Audits and agreements expire, and nothing flags that an order is about to go to a manufacturer whose approval has lapsed.

    A working day

    A specification complaint from a key account

    1. A customer reports that a delivered lot is outside the agreed specification.

    2. Today: the brand asks the manufacturer which batch was involved, then waits for a certificate of analysis and an explanation.

    3. In Worldover: the complaint is already linked to the batch and manufacturer, and the specification history shows the last two deliveries trending the same way.

    4. The manufacturer is asked one precise question about a specific process step, not a general one.

    5. The corrective action is recorded against the manufacturer and checked on the next delivery before it ships.

    How it runs

    How QMS worksinside Worldover.

    01

    Manufacturers are approved with expiry

    Audits, certificates and agreements carry dates, and lapses are visible before an order is placed against them.

    02

    Specifications are agreed and held

    The specification you agreed with the manufacturer is on the record, so deviation is measurable rather than debatable.

    03

    Complaints link to batch and manufacturer

    Every complaint records the batch and manufacturer, so clusters and trends surface early.

    04

    Corrective actions close the loop

    Actions attach to the manufacturer, product and batch, and their effectiveness is checked on the next delivery.

    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.

    Brand quality problems are usually raw material or process problems one or two steps upstream, at a manufacturer or their supplier. Holding the substance record lets you connect a complaint on one product to a raw material lot that may also have gone into products at a different manufacturer.

    Willow

    What teams actually askonce the record is in one place.

    • Are these complaints concentrated at one manufacturer or across several?
    • Which manufacturer approvals or audits are expiring this quarter?
    • Summarise open corrective actions by manufacturer and product.

    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.