In the life sciences industries, documentation plays a crucial role in proving the product's effectiveness and safety. Furthermore, it discusses the processes and practice's dependability, ...

Computer Software Assurance (CSA) is a new methodology that takes a risk-based approach to validation activities. It was driven by the FDA and life sciences industry to streamline verification and ...

The development of new medical devices or any new project brings a new set of risks. A Risk Management Plan (RMP) must be developed at the start of the Risk Management Process for a new project or ...

Join us for an interactive webcast exploring how artificial intelligence (AI) is transforming manufacturing efficiency. This engaging session will highlight practical applications of AI that enhance ...

Innovations and Emerging Technologies in the Regulated Environment of Pharma Effective training programs are essential for maintaining compliance, improving operational efficiency, and ensuring data ...

Navigating FDA 21 CFR Part 11 compliance requires a strategic approach to Computer System Validation (CSV)and Computer Software Assurance (CSA). Title 21 of the Code of Federal Regulations establishes ...

A functional safety standard called IEC 62304 addresses the secure development and upkeep of medical device software. It offers procedures, activities, and tasks to assure safety. From the outset ...

Bringing medical devices to market is a highly complex, challenging, and regulated process. Medical device manufacturers bear the responsibility of ensuring the safety and effectiveness of their ...