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 […]
Why Are You Still Generating Validation Test Scripts Manually?
Drafting validation scripts is one of the key activities in a validation exercise designed to provide document evidence that a system performs according to its intended use. The FDA and other global agencies require objective evidence, usually in the form of screen shots that sequentially capture the target software process, to provide assurance that systems […]
Automated Validation Best Practices
Automation is the key to lean validation practices. Although many validation processes are still paper-based manual processes, there are best practices that support Independent Verification and Validation (IV&V) processes that drive efficiency and compliance. BEST PRACTICE 1 – Establish Independence The IEEE 1012 Standard For System, Software and Hardware Verification and Validation states that Independent […]
