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 […]
Validating Microsoft Dynamics 365: What You Should Know
Microsoft Dynamics 365 and Azure are gaining popularity within the life sciences industry. I am often asked the question about how to validate such a system given its complexity and cloud-based nature. The purpose of this blog post is to answer this question. The outline of this blog post is as follows. Understanding the Changing […]
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 […]
Accelerating Validation in the 21st Century
Each day in companies across the globe, employees are being asked to do more with less. The mantra of the business community in the 21st century is “accelerating business”. You see it in marketing and all types of corporate communication. In the validation world accelerating system implementation, validation and deployment is the cry of every […]
Cloud Validation Strategies
If you were to ask me 10 years ago how many of my life sciences clients were deploying systems in the cloud environment I would’ve said may be perhaps one or two. If you ask me today how many of my clients are deploying cloud’s technologies I would say most all of them in one […]
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 […]
