What the FDA’s Quality Metrics Reporting Program Means for Your Lab
Quality metrics are utilized throughout the pharmaceutical industry to assure product quality and facilitate continued improvement of drug manufacturing processes. The FDA has also shown a significant interest in quality metrics, as data detailing compliance with quality standards in drug manufacturing helps the FDA establish compliance and inspection policies, predict and potentially mitigate future drug […]
Computer Systems Assurance – Methodologies and Technologies to Consider
In our previous blog, we discussed the steps to develop a plan to move to Computer System Assurance (CSA). In this blog we consider the key methodologies and technologies, along with other important considerations to transition to CSA. There are several important factors to consider to ensure a successful transition to CSA. They are focused […]
Quality Management in the Cloud The Technology Advantage and How it Impacts the Quality Function
There are many technologies that are being incorporated at Life Science organizations today to help automate and improve process effectiveness and efficiency. Cloud and edge computing, IoT, robotic process automation (RPA), artificial intelligence (AI), and machine learning to name a few. These technologies assist organizations in reducing cost and downtime, and improving throughput, quality and […]
Computer Systems Assurance – What are the Steps and How to Test?
Computer Systems Assurance entails performing various levels of validation testing based on the software’s risk. The following steps should be followed when leveraging Computer Systems Assurance (CSA): Determine how the software will be used in the organization Is the software affecting the quality of the product or the safety of the patients? If this isn’t […]