.docs:
Purpose-Built
Regulatory Document Management
freya.docs is a cloud-native regulatory DMS purpose built for life sciences, enabling compliant, end-to-end content management across clinical, quality, safety, and regulatory functions. Fully 21 CFR Part 11 and GxP compliant, it offers secure signatures, audit trails, and validated workflows. With metadata-driven automation and integration across modules, it delivers inspection-ready documents and reduces compliance risk at scale.
Real-World Use Cases
Streamline Global Submissions
Manage regulatory documents across regions using built-in compliance templates and reusable content to accelerate approvals for CTA, NDA, ANDA, BLA, and MDR.
Maintain an Audit-Ready Archive
Store all documents in a validated, searchable repository with full version histories, approval records, and traceable activity for inspections and audits.
Enable Real-Time, Role-Based Collaboration
Allow regulatory, QA, packaging, and marketing teams to collaborate securely with controlled access, live editing, and comment threads.
Track and Manage Version Histories
Ensure teams always access the latest approved IFUs, labels, and certificates - avoiding compliance risks tied to outdated documents.
Find Documents Faster with Smart Search
Use advanced metadata filters - by product, region, or document type - to instantly retrieve content and eliminate time spent chasing files.
Spotlight Features
21 CFR Part 11 & GxP Compliance
Secure electronic signatures, full audit trails, and validated workflows to ensure inspection-ready compliance.
End‑to‑End Content Lifecycle
Manage document creation, review, approval, distribution, versioning, and archival across all regulated domains.
Metadata‑Driven Intelligence
Smart tagging and classification enable fast filtering and retrieval across large document repositories.
Preconfigured Submission Templates
Ready-to-use templates (CTD modules, PQRs, IBs) accelerate authoring with consistent, compliant formats.
Role‑Based Access Control
Granular permissions restrict content access and actions based on user role and function.
Submission‑Ready Publishing
Seamless integration with eCTD publishing tools delivers validated documents with full traceability.
Collaborative Authoring & Review
In-line comments, version comparison, and parallel editing eliminate version conflicts and streamline teamwork.
Audit‑Ready Documentation
Complete version histories and system logs keep documents ready for FDA, EMA, PMDA, and internal audits.
Configurable Dashboards & Reporting
Custom views offer real-time insights into document status, overdue tasks, and compliance health.
Scalable Cloud‑Native Platform
Modular architecture supports global teams and integrations with other platforms.
Why freya.docs is the Perfect Solution
Centralize all regulatory documents in one system for faster access, better control, and cross-functional collaboration.
Enable real-time editing, live reviews, and instant approvals to streamline team workflows.
Find the right documents instantly using semantic search and metadata-based filters.
Configure document workflows to match your regulatory processes - no rigid templates or workarounds.
How Does freya.docs Compare
| Features | freya.docs | Other Regulatory DMS |
|---|---|---|
| Unified Platform | A single cloud-native system | Multiple disjointed solutions |
| Search Excellence | Semantic, metadata-driven search | Basic text searches |
| Chat | Ability to upload and chat with the doc using Doc Chat tool | No tool available |
| Structured Content Authoring | Automated component-based authoring of documents | No automated component authoring |
| Integration Ready | Open API supports integration with other upstream and downstream systems | Limited third-party integrations |
| Workflows | Fully configurable workflows | Rigid, one-size-fits-all design |
| Translations | Scientific translation adapted for Life Sciences domain | Generic translations |
