Vidhya eDOC
Electronic DocumenManagement System

A centralized, compliant platform for pharma professionals to digitize, streamline, and safeguard documentation — from creation to audit.

eDOC – Electronic Document Management System | Soinsys
About Vidhya eDOC

Smarter Document Control
for Pharma

Vidhya eDOC is a purpose-built Electronic Form Creation & Versioning System that:

  • Creates and manages electronic forms through a robust Version Control System
  • Maintains complete Audit Trails & Change Logs for every document
  • Supports Pharma-Specific Templates for SOPs, batch records, CAPA & audits
  • Ensures industry compliance with 21 CFR Part 11 & EU Annex 11 standards
  • Integrates with QMS, LIMS & ERP systems seamlessly
Pain Points

Challenges of
Paper-Based Documentation

  • No version tracking — outdated forms in circulation
  • Lack of audit trail and regulatory traceability
  • Manual signatures — time-consuming and error-prone
  • Risk of data tampering and integrity breaches
  • Difficult retrieval during inspections & audits
  • High storage cost and physical space requirements
  • No remote access or real-time collaboration
Solution

How to Overcome the Challenge

1

Form Builder

Create regulatory-compliant electronic forms for pharma workflows.

2

Versioning

Track every form update with full version history and rollback.

3

Compliance

21 CFR Part 11 & EU Annex 11 compliant with digital signatures.

4

Audit Trail

Immutable logs of every view, edit, and approval action taken.

5

Analytics

Real-time analytics and reporting for compliance visibility.

Capabilities

Key Features

  • Informative Dashboard Real-time visibility into document status, pending approvals, and compliance metrics.
  • Role-Based Access Control Granular permissions — authors, reviewers, approvers, and read-only users.
  • Smart Version Control Full history of changes with diff view, rollback, and auto-versioning on every save.
  • Pharma-Specific Templates Pre-built templates for batch records, SOPs, deviation reports, and quality audits.
  • 21 CFR Part 11 Compliant Digital signatures, audit trails, and access controls meeting FDA & EU Annex 11 requirements.
  • Real-Time Analytics & Reporting Instant reports on document lifecycle, compliance status, and user activity.
  • Integration with LIMS & QMS Seamless connectivity with existing quality management and lab information systems.
v1.3 APPROVED Author Approver
Mobile Ready

Document Control
On the Go

Vidhya eDOC Mobile puts complete document control in your pocket. Access, review, and e-sign regulatory documents from anywhere with a fully compliant mobile experience. The intuitive dashboard surfaces pending approvals, overdue reviews, and compliance status at a glance. Role-based access ensures only authorized personnel can view or modify sensitive documents. Version history, audit trails, and change logs are accessible in real time — enabling inspectors and quality teams to respond instantly during audits. With cloud or on-premise deployment options, Vidhya eDOC Mobile meets the needs of distributed pharma teams while maintaining 21 CFR Part 11 and EU Annex 11 compliance on every interaction.

eDOC OK Rev