Market opportunities lie in enhancing risk-based V&V planning, focusing on DQ, IQ, OQ, and PQs to address cGMP deficiencies and regulatory expectations. By aligning with FDA, ICH, and ISO standards, ...

We’ve all heard process validation horror stories. Validations can take years. Creeping elegance can take over. Product launches can be stopped in their tracks. When implemented correctly, however, ...

Software in the healthcare industry has come a long way over the past 20 years. Medical device companies, like most life sciences companies, were a bit hesitant to incorporate software and automation ...

Even with technology changing faster than validation procedures can be rewritten, it still is possible to perform thorough product testing. With the ever-changing complexity of automotive electronics ...

LC-MS/MS has been increasingly adopted by clinical laboratories due to the potential it has for increased sensitivity and specificity over more commonly used analytical techniques. However, ...