6 Pre-Configured Industry Packs for Regulated Sectors
Deploy an inspection-ready eQMS in 8–12 weeks without starting from a blank page or custom coding.
Standard GxP Baseline
ISO 9001:2015 • ISO 31000 • ISO 27001The foundational quality configuration. Out-of-the-box standard risk matrix, 10 core system roles, and Part 11 electronic signature workflows.
Pharmaceutical & CDMO
ICH Q7–Q10 • 21 CFR 210/211 • EU GMP Annex 11Built for drug substance and drug product manufacturing. Pre-configured for Qualified Person (QP) release, batch deviations, and OOS investigations.
Medical Devices & IVD
ISO 13485:2016 • FDA QMSR (21 CFR 820) • EU MDR/IVDRComplete Design Controls (DHF/DMR/DHR), ISO 14971 dynamic risk files, customer complaint handling, and post-market surveillance vigilance.
Biotechnology & Clinical
GLP 21 CFR 58 • GCP ICH E6(R2/R3) • 21 CFR 50/56/312Fast-growth compliance for cell, gene, and biologics innovators moving from pre-clinical research through IND filing to commercial scale.
CRO / CDMO & Testing Labs
ISO/IEC 17025:2017 • GLP • Multi-Sponsor SecurityStrict multi-tenant edge data isolation, test method governance, equipment calibration logs, and external sponsor audit portals.
Healthcare Provider
HIPAA Security • Joint Commission • ISO 15224Clinical incident triage, staff credentialing expiry tracking, patient safety risk governance, and anonymous adverse event intake.