There are four opportunities to apply a Risk-Based Approach for Computer Systems Validation. These opportunities include utilizing risk to scale, supplier audit efforts, validation deliverables, testing and documentation levels. All...
A standardized process is a well-defined and structured set of activities built for conception through retirement. Process Standardization creates transparency across the lifecycle framework and enables management control. It establishes...
A well-defined Lifecycle Framework strategy is designed to create a uniform approach throughout the entire organization. The benefit of having a uniform approach reduces the amount of rework that will...
The pharmaceutical and medical device industry is a rapidly changing environment. Successful businesses are those who are able to stay on top of the newest trends and regulations while aligning...
The regulatory landscape is dynamic in nature, constantly evolving and changing at an accelerated pace. Keeping up with the changing regulations can be an uphill task for organizations in highly...
Computer system validation (CSV) has become essential in the drug and medical device industry. The FDA defines process validation as "establishing documented evidence which provides a high degree of assurance...