Immutable Audit Trail
Every create, modify and approve action is captured with user, timestamp and reason — non-editable by design.
Built to pass inspection, not just audits
Compliance controls are engineered into the platform core so your validation effort shrinks and your inspection evidence is always one click away.
Built against
- 21 CFR Part 11
- EU GMP Annex 11
- GAMP 5
- ALCOA++
- ICH Q10
- WHO GMP
- ISO 9001
- ISO 13485
- FDA
- EMA
- SFDA
- MHRA
Controls are engineered into the platform core, not layered on per project.
Electronic Signatures
Part 11 compliant signature manifestations with meaning, re-authentication and signature binding.
Data Integrity by Design
ALCOA++ enforced at record level: attributable, legible, contemporaneous, original, accurate and enduring.
Validation Package
Pre-executed IQ/OQ documentation, traceability matrix and release notes shipped with every version.
Built against the standards your auditors already use
Quality management, GMP batch manufacturing, data integrity and risk — the frameworks the platform is configured and validated against, across every sector we serve.
ISO 90012015Quality management systemsIATF 169492016Automotive quality managementFSSC 22000v6Food safety system certification21 CFR 211cGMP for finished pharmaceuticalsEU GMP Annex 1Sterile medicinal productsSchedule M+Revised Indian GMP requirements21 CFR Part 11Electronic records and signaturesGAMP 52nd ed.Risk-based computerised validationMHRA GxPData integrity expectationsISO 149712019Medical device risk managementISO 450012018Occupational health & safety
ISO 134852016Medical device quality systemsICH Q10Pharmaceutical quality systemISO 220002018Food safety management21 CFR 820Quality System RegulationWHO GMPTRS 986Good manufacturing practicePIC/S GMPHarmonised GMP inspectionEU GMP Annex 11Computerised systemsALCOA++Data integrity attributesICH Q9Quality risk managementISO 270012022Information security managementISO 140012015Environmental management
Questions enterprise buyers ask us
Most single-site deployments reach production in 8 to 12 weeks, including configuration, validation and training. Multi-site rollouts run as staged waves after the first site is live.