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 In April 2016 the FDA issued new draft guidance for data integrity and compliance with cGMP.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 […]
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 […]
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® […]
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 […]
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 […]
Automated Validation Best Practices
Automation is the key to lean validation practices. Although many validation processes are still paper-based manual processes, there are best practices that support Independent Verification and Validation (IV&V) processes that drive efficiency and compliance. BEST PRACTICE 1 – Establish Independence The IEEE 1012 Standard For System, Software and Hardware Verification and Validation states that Independent […]
The True Meaning of Software Quality
As a long-time validation engineer, I often ponder questions such as “what does it mean to achieve software quality and is it sustainable over time?” I ask myself these questions because in today’s systems environments, there are many factors that can impact software quality assurance. Cyber threats are the elephant in the room. Most validation […]
