QCSFusion Document Management

  • Document Repository for all documents types - internal and external

  • GMP and CFR 21 part 11 compliant

  • E-signaturesCommunication via e-mail (alerts / reminders)

  • Multi-level structure so that documents can be organized effectively

  • Secure documents so that only authorized personnel can 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

  • Searchable

  • Cross-references to link related documents

  • Task list so users can see what tasks are assigned to them

  • Assign time requirements for certain workflows and issue alerts / reminders to assure timely completion

  • Revision history

  • Option to stamp documents for printing

  • Capability to control variety of document types:   

    • SOPs, policies, work instructions   

    • Forms   

    • Regulatory submissions   

    • Regulatory correspondence   

    • Documentation related to change control   

    • Validation documentation   

    • Manuals, instructions   

    • Employee training and qualification records   

    • Project documentation   

    • Investigation documents, photographs, etc.   

    • Audit reports and follow-ups

  • Change control process

  • Editable templates (default and / or user created)

QCSFusion DMS Higlights:

 

  • Extrimely User Friendly  

 

  • Easy customizable processies

 

  • Industry’s most comprehensive and user defined Review/Approval process

 

  • Change control

 

  • CFR 21 part 11 compliant

 

  • Audit Trails 

 

  • E-signatures 

 

  • Communication via e-mail