Regulators are modernizing their expectations, and it's become clear that validation can no longer function as a point-in-time event.

Key market opportunities include enhancing regulatory compliance for medical devices through process validation. Understanding quality management ties, FDA/EU/UK guidelines, and GAMP standards grants ...

CTP Portal Next Generation also accepts Substantial Equivalence submissions. Step-by-step instructions on completing the forms; A more user-friendly interface that helps guide applicants through the ...

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 ...

Is your medical device company ready for the QMSR shift? Engineer Aldo Vidinha explains why "checkbox compliance" is over and how the FDA’s alignment with ISO 13485 redefines quality as a connected, ...

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 ...