Document Management System

Qualis Document Management System

QuaLIS® DMS to take full control of documents right through creation, collaborative content management, approval, request, automated tag filling, issuance and print controls. This also ensures compliance with cGMP and data integrity guidelines prescribed by FDA and MHRA.

QuaLIS DMS is a web-based solution to streamline entire organizations’ documents with full control and traceability. It ensures that the latest released document is used and eliminates the risk of using obsolete documentation. QuaLIS DMS supports electronic signatures and helps regulated industries to stay compliant with cGMP and 21 CFR Part 11.

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  • Deviations/ CAPA
  • Document Management
  • Training Management
  • 21 CFR Part 11/ Eudralex Annex 11/ cGMP compliance
  • Comply with data Integrity guidelines
  • Paper-based / hybrid system
  • Labs transforming for the digital era
  • Web-based DMS that runs on any browser (>IE9, Chrome, Safari, Firefox)
  • Designed for multi-site and multi-department organizations
  • Web Server: Tomcat 7 or above
  • OS: Windows 7, 8, 10, Linux, Mac, iOS, Android
  • Database supported: MS SQL Server 2008 or above
  • Supports MS Office and pdf documents
  • File Storage: FTP Server
  • Others: No limit on file size, configurable parallel & sequential workflow engine, File Version & Print Control

QuaLIS DMS Key Capabilities

Product Specific Highlights

  • Standardization of approval process – Re-approval, archiving and disposal on-time
  • All metadata related to documents stored in a central database
  • Tablet & Desktop user interface
  • Works with a built-in office like editor (MS-Office license not required)
  • Improved quality leads to higher efficiency that translates into higher profitability

Ensure Compliance

  • Comply with the latest cGMP & GLP regulatory requirements
  • Ensure 21 CFR Part 11 & EudraLex Annex 11 compliance and latest data integrity guidelines
  • Stay prepared for audits by regulatory bodies & customers

Ease of Working

  • Controlled access with easy search capabilities including printing & distribution
  • Improved traceability of documents
  • Configurable workflows based on the category of document
  • Alerts on critical aspects of document management phases

Control Documentation

  • Version control of documents from creation to approval
  • Print control
  • Eliminate the risk of using obsolete documentation
  • Secure storage & tracking of electronic documents
  • Brochure

  • Product Note

In Pursuit of Digital Transformation

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