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Paper Execution
The script is outputted in Word format which can be used for  GAMP, cGMPs and 21 CFR part 11 validation.

  1. Expected Result
  2. Screen shot & step imagery dependent on step type and risk.
  3. Script properties auto inserted - Unique Test Ref, Description, Creator, URS/FRS, Pre-requisites, Pre-test steps.

Paperless Script Execution and Electronic Signatures

Manual execution and reports within ProcedureCapture.
• Follow and manually run the Test Script on the screen. 
• Shows run information for every step including expected vs actual and any deviations. 
• Deviations sections of report with errors.
• Save the complete validated and signed report as a PDF record.

Automated execution and reports within ProcedureCapture.

• ProcedureCapture runs the Test Script as if it is the end user. 
• Shows run information for every step including expected vs actual and any deviations. 
• Deviations sections of report with errors and Expected vs Actual Screenshots. 
• Save the complete validated and signed report as a PDF record.

Electronic Signatures within ProcedureCapture.
• Electronic Sigs conform to FDA Part 11 and include User ID, Password and Role in which they are signed. 
• Fully 21 CFR Part 11 compliant, with security encoded features to protect signing information. 
• Workflow protected by User. 
• Add multiple Electronic signature by defined roles to the validation outputs. 

To see more click on the links below

 


To download an evaluation copy and try it yourself, click here.
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