Women in Validation: In Case You Missed It

One of my annual “must attend” events is the Institute of Validation Technology (IVT) Computer Systems Validation Annual Validation Week in October.  This is an excellent event to get the latest and greatest thinking on validation topics and industry guidance.  An official from the U.S. FDA attended the event and providing key information on the […]

Is Your Validation Team Ready For GDPR?

GDPR stands for the General Data Protection Regulation.  It governs all personal data collected by companies for customers, potential customers, employees, and others.  Regulators are keen to understand how this information is managed and maintained over time. In April 2016 the FDA issued new draft guidance for data integrity and compliance with cGMP. The guidance […]

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 […]

Can Cloud Applications Be Validated?

Cloud applications are being deployed within life sciences Enterprises at a rapid pace. Microsoft office 365, Microsoft dynamics 365 and the cost benefit of deployment of other such applications are driving the adoption of cloud applications for regulated systems. The question that is always asked is can cloud systems be validated? The reason for the […]

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 […]

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 […]