The main market opportunities involve providing training and solutions for regulatory compliance and V&V best practices in regulated industries. This includes developing Master Validation Plans, ...

Computational models and simulations have had an important role in engineering analysis since as far back as the 1960s. It is widely recognized that the use of modeling and simulation tools can make ...

Every product has defects. Finding them as early in the development process as possible is definitely something to strive for. Building quality into software as it's being developed is far more ...

So, how long does it take? How much does it cost? Let's dive into the elements of sterile device V&V, picking up after design ...

The life science industry faces opportunities in enhancing cGMP compliance by developing robust, risk-based Validation and Verification strategies. Training on creating effective Master Validation ...

In Chapter 1, verification is defined as the process of determining how accurately a computer program (“code”) correctly solves the equations of a mathematical model. This includes code verification ...

Process validation is crucial for ensuring the quality of final products and the safety of these processes for manufacturing personnel and consumers in the pharmaceutical, medical device, and ...

An overview of the validation and qualification requirements introduced in the 2022 EU GMP Annex 1 revision, with a focus on ...