Documents

Documents is a regulatory content management solution from ArisGlobal, part of the LifeSphere platform. It is designed for life sciences organizations that need to manage submission-relevant content and documentation through to submission readiness, providing a single, authoritative repository for regulatory documents.

The tool is intended for regulatory affairs teams at biopharmaceutical companies, CROs, and related organizations that require controlled, traceable document management aligned with regulatory compliance standards such as 21 CFR Part 11.

Core Capabilities

• Document Control: Supports quality and consistency through common standards, pre-configured templates, and out-of-the-box compliance support.
• Efficiency Gains: Simplifies authoring of complex documents and streamlines document management workflows, including collaboration features.
• Single Source of Truth: Establishes a centralized repository for submission-relevant documentation, enabling traceable reuse of documents across multiple submissions.
• Interoperability: Supports integration with third-party repositories to facilitate cross-functional collaboration and accelerate submission timelines.

Features

• Document Management: Includes audit trails, version control, and template management.
• Built-In Compliance: Supports regulatory requirements including 21 CFR Part 11 compliance.
• Out-of-the-Box Coverage: Provides access to hundreds of pre-configured document types with relevant metadata.
• Standard Workflows: Offers controlled workflows for authors, reviewers, approvers, and other roles.
• Submission Readiness: Built-in rendering produces submission-ready documents; supports reusable hyperlinks and a where-used feature to facilitate submission lifecycle management.
• Third-Party Integrations: Connects with key third-party systems to support collaboration across teams and organizations.

Platform Context

• Documents is part of ArisGlobal's LifeSphere platform, which serves more than 220 global life sciences companies, CROs, and government health authorities, including regulatory bodies such as the FDA, Health Canada, and NMPA.
• ArisGlobal is headquartered in the United States with regional offices in Europe, India, Japan, and China.