Regulatory Solutions

Regulatory Solutions (RDM) from Aurea Software is a document management platform built specifically for the Life Sciences industry. It is designed to manage and centralize regulatory and submission documents throughout their lifecycle, with minimal IT demands and without the high cost of ownership associated with custom-built solutions. The product is positioned as comparable to Veeva and is part of the broader Aurea Compliance Manager (ACM) suite.

RDM starts from an industry-proven configuration and provides tools to tailor processes to individual business needs. It integrates with publishing tools and supports the production of submission-ready documents that meet complex regulatory agency requirements.

Core Capabilities

• Centralized regulatory document management: Manages and centralizes regulatory and submission documents across their full lifecycle, with integration to publishing tools.
• Submission-ready document automation: Guides users through producing submission-ready documents by enforcing CTD standards, applying required templates, and generating PDF renditions that meet agency requirements.
• Preconfigured EDM Reference Model: Includes a taxonomy and metadata reference model developed by Life Sciences industry experts that maps extensively to regulatory requirements, simplifying adherence to industry best practices.
• Enterprise subscription access: The Aurea Compliance Manager Enterprise tier provides access to Clinical, Quality Management, and Regulatory capabilities under a single subscription.

Enterprise Subscription Inclusions

• Regulatory Document Management
• Clinical Documents Module (eTMF)
• Clinical Portal Module (TRX)
• Change Control Solution
• Audit Management Solution
• CAPA Solution
• Deviations/Non-Conformance Solution
• Complaints Solution
• SOP & Training Module
• All future roadmap innovation
• Platinum Support

Onboarding Process

1. Kickoff: Initial phase to align on scope and objectives.
2. Deployment: Technical setup and configuration of the solution.
3. Training: User and administrator training on the platform.
4. Pilot: Controlled rollout to validate the deployment before full go-live.

The Unlimited subscription includes a four-phase onboarding package for every new solution, with expected deployment timelines of 6 to 12 weeks depending on product complexity. Aurea also offers a customer community portal (Worx) providing access to product resources, release notes, Q&A, news, and updates.