Regulatory & Compliance
At Delegra, data integrity and regulatory rigor are the foundations of our architecture. Our platform is engineered to exceed the stringent requirements of global clinical trial environments ensuring that every digital delegation and oversight action is captured with absolute precision. By aligning our internal controls with ICH-GCP E6 (R2) and 21 CFR Part 11 we provide sponsors and investigators with a 'Zero-Latency' audit trail that eliminates the risks associated with manual paper logs. Delegra does not just manage trial documentation: it provides an immutable, inspection-ready ecosystem that protects the validity of your study data from site initiation through to close-out.
- 21 CFR Part 11 Compliance: Full electronic signature attribution and non-repudiation. Build from the ground up to meet MHRA, EMA and FDA electronic record standards. Full audit trails ensure you are inspection ready 24/7.
- ALCOA+ Principles: Ensuring all trial data is Attributable, Legible, Contemporaneous, Original and Accurate.
- GDPR & Data Privacy: Enterprise-grade encryption for Protected Health Information (PHI) and investigator data.
- Automated Audit trails: Time-stamped, unalterable logs for every system interaction.
- Validation-Ready: Software developed under a formal GAMP 5 Software Development Life Cycle (SDLC).
- Proactive PI Signature Tracking: Eliminate the "compliance debt" of manual paper logs. Track investigator oversight in real-time across all active sites.
- Instant Audit Export: Generate formatted, validated delegation logs in one click. Reduce TMF reconciliation time by 80%.
Ensure your next study is inspection-ready Request Stealth Pilot Access