MethodGXP. The Solution for the Confusion. Company’s Background. 20 years specializing in Quality Assurance, Software Engineering and IT Management 10 years specializing in Software Validation 60 Senior Consultants (at least 10Y experience)
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The Solution for the Confusion
Pragmatic solution is required!
A risk based approach will be acceptable, but how do you legally justify your risk assessment?
“…The resultant software validation process should be commensurate with risk associated with system, device or process”
“..risk estimation for software products should be based on the severity of the hazard resulting from failure...”
"The magnitude of software validation effort should be commensurate with the risk associated with the device….“
The categories are based on the increasing risk of system failure with the progression from standard SW and HR to custom…”
Risk Based Approach
Severity & Category
Part 11 Priorities & Efforts
DO IT RIGHT the FIRST TIME