Quality Document Management System (QDMS)

Regulatory compliance with next-generation quality management

Quality Document Management Solutions (QDMS) are key to monitor and control company-wide or departmental policies, processes and procedures. For Life Sciences companies, QDMS provides support in all needs related to content management, including authoring, review and approval, distribution, tracking, storage, access and reporting. 

Amplexor QualityExpert™ is an integral, flexible, and enterprise-ready Quality Document Management System (QDMS) to reduce regulatory risks and improve product safety and quality. This unique next-generation Quality Management Solution, supports regulated data, content management, including documents, processes, quality, submissions, and publishing.   

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Explore how robust quality document management systems processes ensure fast routes to regulatory clearance or approval

Amplexor Quality Document Management Solutions enable:

Predefined templates for each enterprise document to keep consistency across local and global processes (including guidelines, process instructions and procedures).  

Automated workflows, metadata, versioning policies, roles and permissions for quality and R&D documents (SOPs, analytical procedures, flow charts, working instructions, specifications etc.) 

Reuse and repurpose data/content in different internal and external contexts - e.g. product specifications that are used for the laboratory can be reused for the technical agreement or a contract. 

Controlled printing tools to track document’s use outside of electronic environment and support paper copy retrieval and replacement. 

Periodic review and validity extension process – supported by automatic user notifications and expiry date calculator 

Documentation review, with predefined data collection, analysis and reporting.

Training materials and records management

Document validation and qualification, including data cleaning, analysis and computerized system validation.

Real-time reporting for fast and accurate oversight over documentation status and upcoming tasks, supporting audit preparations and qualified decision making.

Quality documentation management includes:

  • SOP management (Quality Manuals, Policies and Guidelines, as well as training documentation)  
  • Quality Control documentation management 
  • Technical agreement management 
  • Validation documentation management 
  • Product Quality Review management 
  • Site Master File management 

Business benefits

  • Harmonize and standardize document management processes
  • Achieve oversight of the process in order to minimize the risks of non-compliance
  • Reduce rework and facilitate reporting in order to minimize efforts and increase productivity
  • Manage, reuse and control quality documents (content) throughout their life cycle
  • Oversee and control document changes and their implementation
  • Support GxP requirements through a validated solution
  • Increase efficiency through a user friendly enterprise remote collaborative environment

Need to optimize quality documents oversight and planning across your organization?

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