Clinical compliance platform

Validated compliance software for modern clinical trials

DocuClin replaces fragmented compliance tools with an integrated, validated platform — built for pharma, biotech, and CROs who can't afford gaps at inspection.

Platform modules

Everything your trial needs

Each module is independently deployable and fully integrated. Start with eTMF and expand as your compliance programme grows.

eTMF

Trial Master File

21 CFR Part 11-validated electronic Trial Master File with AIFA intelligence, inspection readiness, and full audit chain.

SOP

Standard Operating Procedures

Author, train on, and enforce SOPs with competency assessments, trainer sign-off, and lifecycle controls.

QMS

Quality Management

CAPA management, deviation handling, and quality oversight to ISO 13485 and 21 CFR Part 820.

CAPA

Corrective Actions

Track, investigate, and close corrective and preventive actions with full audit trail and effectiveness checks.

CRF

Case Report Forms

Electronic data capture with edit checks, query management, and direct integration with the eTMF layer.

21 CFR Part 11 compliant

OQ validated — 10 scripts passed

MFA enforced, append-only audit

DIA Reference Model v3.0