Staffing Your Next Validation Project: What You Should Know

Finding good talent is always a challenge.  Good people are hard to find.  In the validation world, the unique skill sets required for success are sometimes difficult to find and require diligence to fulfill your objectives.  In today’s competitive environment, a lot of good validation talent is gainfully employed but you can always find good […]

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 […]

Mobility and Validation: Back to the Future

In 2015, the U.S. FDA issues new guidance for Mobile Medical Applications.  Given the widespread adoption and use of mobile technologies, new guidance was necessary to understand how the FDA looks at these devices and enforces them.  While the guidance was prospective in looking at technologies considered to be medical devices, it also pointed out […]

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 […]

Risk Management & Computer Systems Validation: The Power Twins

For as long as systems have been validated, risk is an inherent part of the process.  Although validation engineers have been drafting risk assessments since the beginning of computer systems validation, many do not understand how crucial this process is to the overall validation process. Risk management and validation go hand-in-hand.  The ISPE GAMP 5® […]

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 […]

Accelerating Validation: 10 Best Practices You Should Know in 2018

As we open the new year with resolutions and new fresh thinking, I wanted to offer 10 best practices that should be adopted by every validation team.  The major challenges facing validation engineers every day include cyber threats against validated computer systems, data integrity issues, maintaining the validated state, cloud validation techniques and a myriad […]

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 […]

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 […]

Electronics Records Management For Validated Systems

The 21 CFR Part 11 Electronic Records; Electronic signature final rule has been effective since August 1998.  While much attention has been given to the electronic signature technical controls included within the final rule, less attention has been focused on the electronic records component.  Before we continue with this discussion, it is important to establish […]