Regulatory Content Management

Establish a single, harmonized repository for submission content and documentation.

Documents

Documents gives you everything you need to manage submission relevant content and documentation up to submission readiness.

Document Control

Ensure quality and consistency with common standards, pre-configured templates, and out-of-the-box compliance support.

Efficiency Gains

Save time by making it easier to author complex documents and streamlining common document management workflows and collaboration features.

Single Source of Truth

Simplify content management establishing a single, authoritative repository for submission relevant documentation which facilitates traceable reuse of documents across submissions.

Interoperability

Accelerate submission time and cross-functional collaboration via seamless integrations with third-party repositories.

Features

Deliver real value with Documents.

Document Management

Including audit trails, version control, and template management.

Built-In Compliance

Support for requirements, including 21 CFR Part 11 compliance.

Out-of-the-Box Coverage

Get access to hundreds of pre-configured document types with relevant metadata.

Standard Workflows

Leverage controlled workflows for authors, reviewers, approvers, etc.

Submission Readiness

Built-in rendering produces high-quality, submission-ready documents, support for reusable hyperlinks and where-used feature facilitates submission lifecycle management.

Third-Party Integrations

Seamlessly integrate with key third-party systems for optimal collaboration.