Compliance Manager

Aurea Compliance Manager (ACM) is a document management and compliance platform designed for Life Sciences organizations. It provides end-to-end integrated solutions addressing clinical, quality, and regulatory workflow requirements, and is positioned as comparable to offerings from Cerner, ConvergePoint, and Veeva.

ACM is available in Standard and Enterprise tiers, with the Enterprise edition including a broader set of modules covering clinical document management, quality management systems, regulatory document management, and SOP and training capabilities.

Electronic Trial Master File (eTMF)

• Automates and streamlines clinical trial processes and clinical document management through the ACM Enterprise eTMF module.
• Provides real-time, audit-ready Electronic Trial Master Files via a collaborative platform.

Trial Exchange (Clinical Portal)

• Provides a clinical portal for investigators and site staff to communicate and collaborate with sponsors.
• Allows trial site staff to contribute documents to an eTMF work-stream.
• Enables site staff to receive and complete tasks generated by the sponsor.
• Supports on-demand document retrieval and document status visibility.

Regulatory Document Management

• Manages regulatory and submission documents across their full life cycle within a single organized system.
• Offers a pre-configured solution for submission documentation management.
• Integrates with publishing tools.

Quality Management

• Includes a Change Control Solution.
• Includes an Audit Management Solution.
• Includes a CAPA (Corrective and Preventive Action) Solution.
• Includes a Deviations/Non-Conformance Solution.
• Includes a Complaints Solution.
• Provides transparency and insight across the enterprise while minimizing demands on business and IT users.

SOP and Training Module

• Available as part of the Enterprise subscription tier.

Onboarding Process

1. Phase 1 – Kickoff: Initial project kickoff to align on scope and objectives.
2. Phase 2 – Deployment: Technical deployment of the solution.
3. Phase 3 – Training: User training on the deployed solution.
4. Phase 4 – Pilot: Pilot phase to validate the deployment before full rollout.

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. Enterprise subscribers receive Platinum Support, while Standard subscribers receive Standard Support. All future roadmap innovations are included for Enterprise subscribers. ACM is also available in a cloud deployment model, as noted in related product resources.