What’s Your Biggest Documentation Challenge?
Let’s explore how AI-first document management can bring structure, speed, and compliance to your regulatory workflows.
Document Management Bring Order to
Regulatory Content Chaos
For regulatory affairs teams, publishing specialists, and quality managers, managing thousands of documents across submissions, lifecycle events, and product updates is a daily challenge. With fragmented systems, repeated content creation, and versioning issues, ensuring compliance and traceability becomes difficult. A single misfiled or outdated document can lead to regulatory setbacks, compliance risk, and delayed approvals.
Key Challenges in Regulatory Document
Management
Disorganized and Siloed Document Repositories
Regulatory documents often live in disconnected systems, email threads, or shared drives. Without a centralized repository, teams waste time locating the right version and risk using outdated content.
Version Control and Audit Trails
Maintaining document version history, ownership, and change logs is critical for compliance. Manual processes make it difficult to track edits, approvals, and reviews — leading to audit gaps.
Content Reuse Across Submissions
Regulatory teams often recreate the same documents for different submissions or variations. Without a content modularization strategy, productivity suffers, and inconsistencies creep in.
Global Collaboration and Access Control
Managing access for global teams while ensuring data security and role-based permissions is a delicate balance. Traditional DMS solutions often lack the flexibility for modern, collaborative regulatory work.
How freya fusion Powers Intelligent
Document Management
freya.docs transforms document chaos into structured control with a modern, regulatory-first approach:
Centralized Document Repository
Store, retrieve, and organize documents with metadata tagging, template structuring, and audit-ready access in a validated cloud environment.
Smart Versioning & Traceability
Automatically maintain version control, review logs, and electronic signatures to meet GxP and 21 CFR Part 11 compliance standards.
Modular Content Reuse
Reuse components like cover letters, module summaries, and SmPCs across multiple dossiers using AI-assisted content mapping.
AI-Driven Search and Auto-Tagging
Quickly locate documents by keyword, product, market, or status. freya’s "AI suggests" tags, identifies duplicates, and flags inconsistencies.
Secure Collaboration with Role-Based Access
Enable seamless teamwork across geographies with built-in access control, review workflows, and document locking for high-integrity collaboration.
Future-Proof Your Regulatory Content Operations
As the industry moves toward structured, component-based submissions, having a robust document management strategy is no longer optional. With freya.docs, regulatory teams can:
Reduce time spent on document retrieval and rework.
Ensure submission-ready documentation every time.
Enable seamless collaboration with internal and external stakeholders.
Maintain inspection readiness with full traceability.
Prepare for Structured Content Authoring (SCA) and next-gen submissions.
