Worldover, AI operating system for substance-based businesses

    Part of the Worldover AI operating system

    CAPA and complaint management softwarelinked to the batch it's about.

    A complaint or deviation is only useful if it leads somewhere: an investigation, a root cause and an action that stops it happening again. Worldover links each complaint and CAPA to the batch, lots and formula involved, so investigations start with the facts.

    Last reviewed by the Worldover regulatory team.

    Quick answer

    CAPA (corrective and preventive action) software manages the path from a complaint, deviation or audit finding to a verified fix. It records the issue, runs the investigation, assigns actions and checks effectiveness. For GMP manufacturers it needs to link each record to batches, lots and formulas. Worldover does this on the same record as production and quality release.

    • Complaints, deviations and audit findings in one workflow
    • Each record linked to batch, lots and formula version
    • Investigations with root cause and assigned actions
    • Effectiveness checks before a CAPA closes
    • Trends across products, suppliers and sites

    CAPA and complaint management software for GMP · Worldover

    What to look for in CAPA and complaint management software

    • Complaints, deviations and audit findings captured in one place and linked to batches and products.
    • Triage with severity, so serious issues are escalated quickly.
    • Root cause investigation with the batch, lot and supplier data to hand.
    • Corrective and preventive actions with owners, due dates and effectiveness checks.
    • Trends across complaints and deviations, so repeat issues are visible.
    • Customer responses drafted from the investigation, reviewed before sending.
    • A full history for audits and management review.
    • Links to specifications, formulas and training when an action changes them.

    Why complaint handling stalls

    Complaints arrive by email, get logged in a spreadsheet and are investigated by pulling batch records from another system. Trends go unnoticed because nothing connects complaint number 12 with complaint number 40 on the same raw material lot.

    What GMP expects from CAPA

    ISO 22716 and GMP guidance expect documented investigation, root cause, corrective action and a check that the action worked. Auditors look for the link between the issue and the fix.

    How Worldover manages CAPA

    Complaints and deviations open against the batch, so the lots, formula and release record are already attached. Willow groups related issues, drafts the investigation summary and suggests actions for the quality team to decide on.

    A worked example: a complaint about separation

    A retailer reports that a lotion is separating on shelf. The complaint is logged against the product and batch, and the investigation opens with the batch record, raw material lots and stability data already attached.

    The trace shows a change of emulsifier supplier two months earlier, and two other complaints for batches made since. A corrective action is raised to review the emulsifier specification, and a preventive action adds a check at incoming inspection. Willow drafts the customer response from the investigation notes, and quality approves it before it's sent.

    What Worldover's CAPA is built for

    Worldover supports GMP and ISO 22716 quality processes for chemicals and cosmetics companies, with complaints and CAPA linked to the batch, formula and supplier data they depend on.

    It isn't marketed as a validated quality system for medical devices or medicinal products. If you operate under those regulations, we'll be clear about what's in scope before you commit.

    Meet Willow

    The AI connective tissue that flows through the entire operating system.

    Meet Willow
    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

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