Medical Device Manufacturing Software

    Audit-ready from design to deployment

    One gap in documentation can mean costly delays or recalls. GxP Track gives you full traceability across design, assembly, and quality. Stay inspection-ready while scaling at speed.

    FDA 21 CFR Part 11

    Compliance Friendly

    EU Annex 11

    Compliance Friendly

    ISO 27001

    Compliance Friendly

    SOC 2

    Compliance Friendly

    Built for precision manufacturing

    GxP Track℠ helps you move faster and stay fully control aware from design input to final release.

    Simple design control

    Manage protocols, documents, & training across the product lifecycle. All from one place, without the confusion of siloed systems.

    Instant traceability

    Automatically capture & tag each assembly or inspection step under a verified user ID, so you can prove who did what & when.

    Fast, smart approvals

    Streamline reviews, sign-offs, & escalations with role-based workflows & secure eSignatures. Cut approval delays. Reduce errors.

    Audit-ready always

    Export structured records for ISO 13485 or FDA inspections in seconds, with every step traceable & nothing left to chance.

    Seeking Phase I Participant Organizations (Confidential Source Code Disclosure Considered)

    No MES workarounds.

    Just purpose-built tools.

    Other solutions

    Limited flexibility for design iterations
    Complex validation workflows
    Siloed event & SOP tracking
    Manual traceability mapping
    Heavy IT lift for updates

    GxP Track℠

    Modular tools to adapt as designs evolve
    Easy-to-validate components
    Unified audit-ready records
    Auto-tagged, timestamped logs tied to users
    Scalable without dev cycles or rewrites

    Built for ISO 13485. Designed to scale.

    GxP Track℠ gives you the control and agility to stay Compliance Friendly while supporting faster innovation.

    Design History File logging

    Capture every input, update, and approval related to your product design automatically. All records are user-tagged and timestamped to maintain a complete, audit-ready Design History File.

    CAPA & nonconformance links

    Log deviations as they happen and instantly trigger investigations. Link CAPAs to root cause events and track every follow-up action through resolution with full traceability.

    Role-based training & approvals

    Assign protocol-specific training and approval workflows based on team, department, or product. Monitor completions, sign-offs, and escalation paths using verified digital signatures.

    Real-time audit logs

    Log every action across your process, from inspection steps to document changes, in real time. Search by user, time, or task to produce instant, regulator-ready records.

    Scalable across devices & teams

    Easily extend GxP Track℠ across new product lines, sites, or teams without rework. No custom development or long onboarding cycles required.

    See how it's working for teams like yours

    Check periodically for case study updates.

    80%

    Striving for faster review & release

    100%

    Striving for right-first-time output

    50%

    Striving for reduction in processes

    Supporting organizational data compliance across industries

    See how GxP Track℠ adapts to other high-stakes industries.

    Life Sciences

    Drug Discovery

    Clinical Trials

    Pharmaceutical Companies

    Strengthen organizational data compliance and scale with confidence wherever your operation grows.

    Device organizational data compliance down to a science

    Book a demo to see how GxP Track℠ simplifies traceability, streamlines audits, and supports ISO 13485 from design to release.