Regulatory Assurance
Global Regulatory & Qualification Compliance Matrix
Certification Standards: FDA 21 CFR Part 11, GAMP 5, EU ESPR, US DOE SCRM, NIS 2 Directive
DossierEngine™ is pre-architected to satisfy strict international manufacturing and critical infrastructure directives across Pharmaceutical, Life Sciences, and Heavy Power Grid sectors.
| Regulatory Directive | Jurisdiction / Sector | DossierEngine Architecture Realization |
|---|---|---|
| FDA 21 CFR Part 11 | United States / Life Sciences | Cryptographic audit trails, computer systems validation (CSV) readiness, time-stamped e-signatures. |
| GAMP 5 Category 4 | Global Pharma Automation | Configured software platform architecture supporting risk-based validation packages. |
| EU ESPR (DPP) | European Union / Industry | GS1 Digital Link URI resolver rendering material provenance, carbon tracking, and repairability dockets. |
| US DOE SCRM / SPARK | United States / Power Grid | Supply chain software isolation, outbound-only MQTT/HTTPS JSON, automated FAT ledger verification. |
| NIS 2 Directive (Art 20/21) | EU Critical Infrastructure | eIDAS Qualified Electronic Seals, 24-hour incident notification logging, role-based OTP shields. |
Validation Documentation Packages
Enterprise subscribers can request complete IQ/OQ/PQ validation protocols and SCRM audit packages by contacting our compliance desktop:
Compliance Helpdesk: compliance@dossierengine.com