In Case You Missed It: CSV ValidationMaster Class
In case you missed it, in December 11- 13 KenX conducted the Computer System Validation and Data Integrity Congress. Recently, the FDA has issued warning letters regarding non-compliance of validated computer systems. Findings have included issues such as inadequate risk analysis, non-independent audit trails (audit trails that could be manipulated or turned on/off), failure to […]
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 […]
Installation Qualification (IQ) in the Cloud
Installation Qualification (IQ) is designed to ensure that systems are installed in a consistent, repeatable manner. For on-premise systems, validation engineers typically install enterprise software from pre-defined vendor media. Formerly, media was inserted into corporate servers and the full installation process is documented. The purpose for installation qualification sometimes gets lost in the weeds. Given […]
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 […]
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 […]
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 […]
