Automating Validation Testing: It’s Easier Than You Think

Automated validation testing has been elusive for many in the validation community.  There have been many “point solutions” on the market that addressed the creation, management and execution of validation testing.  However, what most validation engineers want is TRULY AUTOMATED validation testing that will interrogate an application in a rigorous manner and report results in […]

Saving Time and Money Through Lean Validation

The principles and best practices of lean manufacturing have served life sciences manufacturers well.  Lean is all about optimizing processes, while eliminating waste (“Muda”) and driving greater efficiencies.  As a 30-year validation practitioner, I have validated many computer systems, equipment and processes.  One of the key lessons learned is that there is much room for […]

Leveraging the NIST Cybersecurity Framework

As a validation engineer, why should you be concerned about Cybersecurity?  Good question!  Today’s headlines are filled with instances of cyber attacks and data breaches impacting some of the largest corporate systems around.  As validation engineers, our job is to confirm software quality and that systems meet their intended use.  How can you realistically do […]

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