Qualis DMS

Qualis DMS is an enterprise-class, compliant, and paperless document management system developed by Agaram Technologies. Built to address the growing need for structured document control across all industry verticals, it provides a secure and intelligent platform for creating, storing, tracking, and managing documents throughout their entire lifecycle — from initial draft to final approval and distribution. The system is designed to align with FDA/MHRA cGMP guidelines and supports full compliance with 21 CFR Part 11, EU Annex 11, and ISO standards.

Qualis DMS serves as a central hub for total document control, replacing scattered files and chaotic folder structures with a single source of truth. It is well-suited for multi-site and multi-department organizations that require segregated control, role-based access, and comprehensive auditability across their document operations.

Document Repository and Authoring Capabilities

• Create and Edit: Author SOPs, manuals, and protocols using advanced tools for professional formatting, structured templates, and automatic pagination.
• Upload and Import: Store documents in a digital repository via bulk import, drag-and-drop, email-based upload, or monitored folders with metadata tagging.
• Advanced Document Authoring: Structured authoring tools support professional document creation with consistent formatting.
• Template and Form Management: Create reusable templates that enable consistent, structured data entry and standardize data capture to reduce manual effort.
• Multi-Format File Support: Natively handle Microsoft Office, PDF, images, AutoCAD, rich text, and more.
• Effortless Bulk Uploads: Migrate entire projects or archives in a single step using the secure bulk upload feature.

Document Organisation and Retrieval

• Workspaces and Nested Folders: Classify documents by department, client, or project in an easy-to-navigate interface.
• Custom Tags and Metadata: Smart full-text and metadata search allows users to locate documents based on tags, content, version, author, or audit events across multi-site repositories.
• Intuitive Dashboard and Alerts: Get a comprehensive overview of document activity and team status at a glance.
• Access Control: Define user roles and permissions to maintain data security, with tiered sensitivity tagging (e.g., Confidential, Internal) to ensure only authorised personnel access the right information.
• Multi-Tenant and Multi-Site Architecture: Supports segregated control across multiple tenants and sites.
• Secure Sharing: Share documents safely using access control mechanisms.

Version Control and Print Management

• Automatic Version Control: Automated versioning with comprehensive audit trails ensures full traceability of all document changes, always surfacing the latest approved version.
• Version-Controlled Publishing: Ensure output is always generated from the correct file version.
• On-Demand Publishing: Print or publish any selection of documents on demand.
• Controlled Print Management: Set up controlled access and approvals for printing and reprinting activities.

Workflow Automation and Form Management

• Workflow Management Engine: Supports serial, parallel, and hybrid workflows tailored for each document type, with role-based privileges for document review and e-signature approval.
• Business Process Management (BPM): Define templates for complex document-driven workflows such as CAPA, deviation handling, or audit responses, with cascade escalations and multi-stage reviews.
• Case Management: Group related documents into a centralised case file (e.g., CAPAs, audits, lab reports) with milestone tracking, linked-file associations, and condition-based branching workflows.
• Auto-Populate Form Details: Autofill form headers with dynamic values such as batch number, product name, and issuance date and time.
• Seamless Workflow Triggering: Auto-trigger workflows upon form submission for use cases like calibration, deviations, or incident reporting.

Compliance, Security, and Audit Readiness

• Electronic Records and E-Signature Support: Fully compliant with 21 CFR Part 11, EU Annex 11, and ISO standards.
• Comprehensive Audit History: Maintains a complete record of every action taken on a file throughout its lifecycle.
• Password Policy Control: Configurable password rules and authentication mechanisms can be set according to organisational preference.
• Traceability: Track changes and approvals with precise version and release control.

Key Benefits of Qualis DMS

• Paperless System: Standardised browser-based access eliminates physical storage dependency.
• Low Compliance Cost: Built-in role-based control and traceability reduce audit-related expenses.
• Improved Collaboration: Central access improves teamwork and document ownership visibility.
• Scalable and Extensible: Ideal for multi-site or multi-department deployment.

Qualis DMS is cloud-ready and integrates seamlessly with SharePoint, Google Drive, and OneDrive. It supports auto-import of documents from monitored folders and enables publishing to network folders or team libraries for broader collaboration. The platform is part of Agaram Technologies' broader suite of laboratory and quality management solutions, which includes Qualis LIMS, Logilab ELN, Logilab SDMS, and Interfacer Middleware.