As of January 2026, the Centers for Medicare & Medicaid Services has officially launched its Skilled Nursing Facility ...

This suite automates the commissioning, qualification, and validation (CQV) of processes, equipment, and systems. It includes three AI-enabled applications: Together, these systems work in tandem to ...

The European Medicines Agency (EMA) has finalized guidance intended to help sponsors meet the data requirements for process validation for biotechnology-derived active substances. The guidance, which ...

In biopharmaceutical manufacturing, consistency is vital but hard to achieve. Turning raw materials into safe, high-quality medicines requires stable processes. However, the living cellular expression ...

The European Medicines Agency (EMA) has released a new draft guideline on process validation that brings EMA thinking in line with the International Conference on Harmonization of Technical ...

Dr. Siva Samy is the founder and CEO of ValGenesis, an inventor with 8 patents in digital and AI-based validation, and a Ph.D in Pharma. For decades, validation in life sciences has been treated as a ...

Medical device equipment manufacturers work in an environment where product quality isn't just a competitive advantage, it's a regulatory necessity with direct implications for patient safety. As ...