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, ...
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 ...
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 ...