Accelerating validation for Acumatica ERP systems

In case you haven’t heard, Acumatica has been listed in Gartner’s magic quadrant as one of the leadingERP systems on the market. The system includes an innovative X RP platform that includes the fullgamut of supply chain functionality including Financial Management, Warehouse Management, OrderManagement, Project Accounting, CRM, Payroll, Construction Management, Point of Sales, InventoryManagement, and […]

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 […]

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 In April 2016 the FDA issued new draft guidance for data integrity and compliance with cGMP.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 […]

What Data Integrity Means For Validation

After much fanfare, the general data protection regulations (GDPR) was approved by the EU parliament on April 14, 2016. The enforcement date for this regulation is May 25, 2018. If companies are not in compliance at that time the potential for heavy fines is inevitable. The EU general data protection regulation replaces the data protection […]

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 […]

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 […]

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 […]

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 […]