Electronic Signature Capability
Compliant with 21 CFR 11
   
Electronic Forms and Reporting Capability
Automate form processes such as CAPA, DCN and clinical studies. Create associated custom reports.
   
Change Logs
Complete audit trail for all form data changes.


   
Document History Logs
Audit trails for all activities associated with key documents.
   
Software Validation
Implementation guidance and support for system validation
   
Software Requirements Specification
Complete documentation set for quality control, functional testing and configuration management.


Description
   

VisualVault - Device & Pharma: A fully integrated system proven to meet the rigors of 21 CFR 11 Electronic Records and Electronic Signature requirements. This product will provide a complete foundation for your compliance systems and clinical studies.

Embedded workflows and a structured role based security model ensures distribution of key information on a controlled basis. The Regulatory Manager will enjoy the benefits of information control, and detailed histories. The organization will enjoy the benefits of ease-of-use, distributed ownership and reduced compliance costs.
Standard Benefits of VisualVault
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