QCSFusion Document Management
The QCSFusion Documents Management System organizes documents according to the department in which they were initiated. Subfolders can be used to further categorize documents within each department. User access can be assigned so that users only have access to relevant documents.
The document review process enables users to comment on documents. Once all reviewers have commented, the document is returned to the document owner for editing. The review cycle is then repeated until all reviewers are satisfied. Once the final version is approved by all reviewers, the document is circulated for electronic signatures indicating final approval.
The document is then converted to PDF and retains properties such as hyperlinks and all of the assigned attributes. Electronic signatures are added to the signature page and the document’s revision number and effective date are applied to all pages.
Built-in GMP and CFR Part 11 compliance provide a comprehensive solution that makes review and approval of critical documents simple and efficient. The software leverages the roles of authors, editors and reviewers by ensuring that the documents and records submitted to the regulatory authorities are complete and accurate. QCSFusion provides a cost-effective solution by enabling efficient document management, review and approval.
Features
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Document Repository for all internal and external documents
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Compliant with CFR 21 Part 11 and GMPs
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E-signatures
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Communication via e-mail (alerts / reminders)
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Multi-level file structure allowing effective document organization
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Secure documents allowing only authorized personnel to move, edit, archive
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Detailed audit trail includes:
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System-stamped date and time
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User who performs the activity
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Information of action performed
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Reason for changes
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Flexible roles / responsibilities that can be assigned based on customer needs
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Review and Approval workflow
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Cross-references to link related documents
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Task list allows users to see which tasks are assigned to them
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Assign time requirements for certain workflows and issue alerts / reminders to assure timely completion
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Searchable
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Revision history
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Option to stamp documents for printing
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Capability to control variety of document types:
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SOPs, policies, work instructions
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Forms
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Batch records
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Certificates of Analysis (C of As)
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Regulatory submissions
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Regulatory correspondence
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Deviations / Investigations - CAPA
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Documentation related to change control
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Validation documentation
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Manuals, instructions
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Employee training and qualification records
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Project documentation
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Investigation documents, photographs, etc.
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Audit reports and follow-ups
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Change control process
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Editable templates (default and / or user created)