Catalyst D2RS

Catalyst Document Management Systems (DMS / D2RS)

Catalyst D2RS (Document Distribution and Retreival System) is a modern Document Management System engineered for the pharma, biotech and medtech industries.

It replaces fragmented document handling with a single controlled platform — managing creation, review, distribution and retrieval of critical documents with full traceability.

The result: faster turnaround, fewer errors, tighter control, and inspection-ready compliance with FDA 21 CFR Part 11 and GxP standards.

Catalyst D2RS Image

What Makes Catalyst D2RS Different

Purpose-built for regulated pharma document control — import your existing PDFs and Word files in bulk, author new documents in the built-in intelligent document designer with no MS Word licences, and manage the complete document lifecycle with configurable, audit-ready workflows out of the box.

Key Benefits of Catalyst D2RS :

  • • Complete Document Lifecycle Management - Manage every controlled document from creation and review through approval, distribution, revision and retirement — with full version history and revision traceability at every stage.
  • • Electronic Review & Approval Workflows - Route documents through configurable review and approval chains with role-based sign-offs, parallel or sequential routing, and electronic signatures compliant with 21 CFR Part 11.
  • • Enforced Print Control - Prevent uncontrolled printing of SOPs, work instructions and specifications — track every copy issued, watermark controlled prints, and enforce print permissions by role, department or site.
  • • Obsolete Copy Management - Automatically flag, withdraw and archive obsolete documents on revision — ensuring no superseded copy remains in circulation and every controlled location reflects the current approved version.
  • • Secure Distribution & Retrieval - Deliver the right document to the right user, at the right time — with role-based access, controlled distribution lists, read-and-understand acknowledgement and instant search across the full document repository.
  • • FDA 21 CFR Part 11 & GxP Compliant by Design - Role-based access control, electronic signatures, secure time-stamped audit trails and ALCOA+ aligned data integrity controls built into every document workflow.
  • • Training Management System Linkage - Automatically trigger training or acknowledgement tasks when a document is revised — with full control on which version is accessible to the users.
  • • Templates, Numbering & Metadata Control - Standardise document creation with configurable templates, numbering schemes, metadata fields and effective-date rules — ensuring consistency across sites, departments and document types.
  • • Seamless Platform Integration - Integrates natively with the rest of the Catalyst platform — QMS, LIMS, eBMR, eLogBook, Calibration & Maintenance and APQR — and with your ERP, giving you a single controlled source of truth for all GxP documentation.

Catalyst D2RS replaces fragmented file shares, uncontrolled email circulation and paper-based document control with a single validated platform. Its configurable design and enforced control mechanisms reduce compliance risk, accelerate document turnaround and make every inspection faster — while consistently meeting global expectations including FDA 21 CFR Part 11, EU GMP Annex 11, GxP and ALCOA+ data integrity.

Create documents in D2RS. No file stored on users laptop.

Automatic distribution register maintenance.

Automatic version control of documents.

Automatic document numbering.

Automatic obsolete copy management.

Easy Integration with SAP, Catalyst QMS or other software's.

Frequently Asked Questions (FAQ's)

What is a Document Distribution and Retrieval System (D2RS)?

A Document Distribution and Retrieval System is a specialised Document Management System (DMS) for Pharma that controls how GxP documents are created, reviewed, approved, distributed and retrieved across an organisation. Unlike generic DMS, a D2RS enforces version control, access permissions, print control and obsolete copy management — ensuring that only current, approved documents are in use at every location.

How do I import my existing documents?

Catalyst D2RS includes bulk import facilities that allow you to directly load signed PDFs as well as Microsoft Word (.docx) files into the system. Existing word documents are directly imported and auto adjusted with AI to include the intelligent headers and footers required for automated numbering. This eliminates the manual effort typically required for data migration and enabling faster go-live.

Do I need a Microsoft Word license on every laptop to use Catalyst D2RS?

No. Catalyst D2RS includes a built-in web-based editor with same MS word like interface — so authors can create, edit and format controlled documents directly in the browser without any Microsoft Word installation or per-seat licensing. This reduces software cost and simplifies deployment across sites, contractors and remote users.

Is Catalyst D2RS compliant with FDA 21 CFR Part 11 and GxP?

Yes. Catalyst D2RS is designed for FDA 21 CFR Part 11 and EU GMP Annex 11 compliance, with role-based access control, electronic signatures, secure time-stamped audit trails and ALCOA+ aligned data integrity controls built into every document workflow.

What is print control and why does it matter in a pharma DMS?

Print control restricts and tracks the printing of controlled documents such as SOPs, work instructions, specifications and batch records. It ensures that only authorised users can print, that every printed copy is uniquely identified (via watermark, copy number or controlled stamp), and that printed copies are recalled or reconciled when a document is revised. This prevents uncontrolled, superseded copies from being used on the shop floor — a common audit finding in paper-based systems.

How does Catalyst D2RS handle obsolete copy management?

When a document is revised or withdrawn, Catalyst D2RS automatically flags the previous version as obsolete, removes it from active distribution, and archives it with a full retention record. Controlled locations are notified for physical copy reconciliation, and users lose access to the superseded version — eliminating the risk of obsolete documents remaining in circulation.

Does Catalyst D2RS handle version control and revision history?

Yes. Every document is version-controlled with a complete revision history — including author, reviewer, approver, effective date, reason for change and all superseded versions. Version history and full traceability make audits, inspections and change impact assessments significantly faster.

Can Catalyst D2RS integrate with other quality and manufacturing systems?

Yes. Catalyst D2RS integrates with ERP for master data, and connects natively with the rest of the Catalyst platform — QMS, LIMS, eBMR, eLogBook, Calibration & Maintenance, Training and APQR — giving you a single controlled source of truth for all GxP documentation across the enterprise.

Does Catalyst D2RS support training and read controls?

Yes. When a document is revised, Catalyst D2RS can automatically trigger training for affected users — with full traceability of who has completed the trainings and when. This links document control directly to your training compliance records.

How quickly can Catalyst D2RS be implemented and validated?

Implementation is fast thanks to the configurable, out-of-the-box design. Document types, templates, approval workflows and access rules are set up through configuration rather than custom code, and full CSV (Computer System Validation) documentation with IQ/OQ/PQ protocols and 21 CFR Part 11 compliance support is provided as part of the rollout.