RegDocs365

RegDocs365 is a best-of-breed, regulated content and document management solution for life science companies hosted in an Audit Ready Compliant Cloud (ARCC) validated environment.

> 1,000+ submissions to global regulatory authorities using RegDocs365
> 95% client retention rate
>A highly cost-efficient solution for life science

  • Complies with FDA 21 CFR Part 11 audit trail requirements

  • A unified content repository that seamlessly integrates with any commercial grade product for real time document visibility

  • Effectively centralizes and manages all digital content (documents, data, voice, and video) to create, protect, and publish in multi-sponsor environments

  • An easy authoring and full functional document management tool with seamless eCTD publishing integration

  • Intelligent data governance – characterize, unify and store multi-structured data

  • Remote document management, 24/7 on demand access with robust security and two factor authentication

  • Supports the use of Quality by Design principles (QbD)

What Makes RegDocs365 Different?

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Risk-based Quality Management and Compliance

  • 21 CFR Part 11 compliant tools support eSignature, eCTD, EDM & eTMF Reference Models, GxP audit ready and submission-ready PDF rendering

  • Path to scale across multiple sponsors and multiple studies in a single compliant environment

  • Full audit trail and versioning for audit readiness and timely filing

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Unify CRO Operations-- Improve Efficiencies

  • Supports compliant submission ready documents with EDM Reference Models and eTMF

  • Work in parallel on multiple projects within multiple sponsors in the same environment

  • Standardize training across teams and locations for consistency across multiple projects

  • Real-time visibility and collaboration tools

  • Out-of-the box, pre-configured workflows for multiple sites, tailored to specific customers

  • Built-in reports tailored to your unique requirements enabling customized reports on the fly

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Secure Content Access

  • Long term, active digital preservation-- access content today or in a decade from now

  • Set granular permissions – enable document level permissions per user 

  • Ensure data governance across multiple systems, studies and sites in a secure compliant environment

  • Multi-layer security for sensitive data