SharePoint Validation: Quality and Compliance Portals
I am often asked the question… “can SharePoint be validated?” The short answer is YES but it often requires customization to achieve deliver compliance objectives. The longer response requires further examination as to why people ask the question and the nature of SharePoint as a content management system. With the release of Office 365® reaching over […]
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 […]
5 Ways to Revive Your CSV Validation Process in 2018
If you are like most veteran validation engineers, you have been conducting validation exercises the same old way. You have been gathering user requirements, conducting risk assessments, developing test scripts (most often on paper) and delivering validation documentation and due diligence as required by current global regulations. Validation processes have not changed very much over […]
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 […]
Understanding Lean Validation: A Practical Approach
Lean manufacturing has been with us since 1988. Lean principles were derived from the Japanese manufacturing industry. The “Lean” process was originally created and adopted by Toyota designed to eliminate waste and inefficiency in its manufacturing operations. Lean processes led to the Toyota Production System (TPS) which is arguably one of the greatest manufacturing success […]
Computer Systems Validation As We Know It Is DEAD
Over the past 10 years, the software industry has experienced radical changes. Enterprise applications deployed in the cloud, the Internet of Things (IoT), mobile applications, robotics, artificial intelligence, X-as-a-Service, agile development, cybersecurity challenges and other technology trends force us to rethink strategies for ensuring software quality. For over 40 years, validation practices have not changed […]
How Vulnerable Is Your Validated System Environment?
If you are a validation engineer reading this post, I have a simple question to ask you.. “How vulnerable is your validated systems environment?” Has anyone ever asked you this question? How often do you think about the impact of a cyber threat against your validated computer system? I know… you may be thinking that […]
