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Process Qualification can require a high degree of manual effort for tracking and reporting, and the execution of most validation protocols takes place on paper.

Paper and manual based validation can be both time consuming and document intensive and may compromise a life science firm’s ability to bring products to the market on time.

Using Electronic Records and Signatures has the potential to reduce this time and effort and ProcedureCapture allows you to reuse the same test script assets that have been created for paper execution.

All created assets are therefore "electronic signature ready" ProcedureCapture allows you to Electronically sign and countersign both approvals and validated outputs. 

  • Enables a 100% paperless validation process.
  • Electronic Validation process meeting compliance requirements.
  • Globalizes the Validation process and leverages the resources across the sites.

Pre Approval.
• Approve the script and electronically sign the approval. 
• Test script is 'locked' and cannot now be edited or changed. 
• Every subsequent execution of the script will contain the electronic approval signature in the run results. 
• Full audit trail of approvals.

Post Execution Approval
• Electronically sign the test execution documentation.
• Fully compliant, with security encoded features to protect signing information. 
• Workflow protected by User. 
• Multiple Countersigns using a different Users. 
• Add multiple Electronic signature by defined roles to the validation outputs

.To learn more go to


 
To see how ProcedureCapture works, please click here.

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