QCSFusion Document Management
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Document Repository for all documents types - internal and external
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GMP and CFR 21 part 11 compliant
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E-signaturesCommunication via e-mail (alerts / reminders)
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Multi-level structure so that documents can be organized effectively
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Secure documents so that only authorized personnel can move, edit, archive
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Detailed audit trail include
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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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Searchable
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Cross-references to link related documents
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Task list so users can see what 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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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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Regulatory submissions
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Regulatory correspondence
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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)
QCSFusion DMS Higlights:
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Extrimely User Friendly
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Easy customizable processies
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Industry’s most comprehensive and user defined Review/Approval process
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Change control
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CFR 21 part 11 compliant
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Audit Trails
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E-signatures
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Communication via e-mail