QCSFusion Document Management Module

Introducing the QCSFusion Document Management Module, a cutting-edge solution inspired by industry best practices. This advanced software is designed to seamlessly organize documents and establish a unique workflow for document handling processes in your organization.

The system intelligently categorizes documents based on their originating departments, utilizing subfolders for enhanced granularity. User access is finely tuned, granting individuals tailored permissions to ensure they interact only with pertinent documents. The collaborative document review process empowers users to provide valuable feedback, with an iterative cycle that continues until all stakeholders are satisfied.

Upon achieving unanimous approval, the document effortlessly progresses to the electronic signature phase, marking its official endorsement. The system excels in maintaining document integrity during conversion to PDF, retaining essential properties such as hyperlinks and assigned attributes. Electronic signatures seamlessly integrate onto the signature page, accompanied by meticulous details such as the revision number and effective date for a complete audit trail.

QCSFusion sets the industry standard for compliance, incorporating GMP and CFR Part 11 features that align with all requirements. The system optimizes document workflows by leveraging the roles of authors, editors, and reviewers, ensuring submissions to regulatory authorities are consistently complete and accurate.

Beyond regulatory excellence, QCSFusion is a cost-effective solution, streamlining document management, review, and approval processes. Transitioning from a paper-based system to an automated one enhances management efficiency and provides better control over documents. Elevate your document handling with QCSFusion, a synthesis of proven best practices in Document Management software.


  • Document Repository for all internal and external documents
  • 21 CFR part 11 compliant
  • E-signatures
  • Communication via e-mail (alerts / reminders)
  • Multi-level file structure allowing effective document organization
  • Secure documents allowing only authorized personnel to move, edit, archive
  • Detailed audit trail include

    • System-stamped date and time

    • User who performs the activity

    • Information of action performed

    • Reason for changes

  • Flexible roles / responsibilities that can be assigned based on customer needs
  • Review and Approval workflow
  • Cross-references to link related documents
  • Task list allows users to see which tasks are assigned to them
  • Assign time requirements for certain workflows and issue alerts / reminders to assure timely completion
  • Searchable

  • Revision history
  • Option to stamp documents for printing based on company designed rules
  • Capability to control variety of document types:

    • SOPs, policies, work instructions

    • Forms

    • Batch records

    • Certificates of Analysis (C of As)

    • Regulatory submissions

    • Regulatory correspondence

    • Deviations / Investigations - CAPA

    • Documentation related to change control

    • Validation documentation

    • Manuals and instructions

    • Employee training and qualification records

    • Project documentation

    • Investigation documents, photographs, etc.

    •  Audit reports and follow-ups

  • Change control process
  • Editable templates (system default and / or user created)