Continuous manufacturing and a quality-by-design development approach are a natural fit. FDA, as well as other regulatory agencies around the world, have for many years been encouraging drug makers to ...

In the modern pharmaceutical industry, the term ‘biologics’ is used for engineered macromolecular products (or therapeutic proteins), such as monoclonal antibodies, cytokines and growth factors 1,2.

Following the launch of its initiative, "Pharmaceutical cGMPs for the 21st Century: A Risk-Based Approach," FDA has been looking to process analytical technology (PAT) for improvements in process ...

The higher education accreditation system relies on infrequent, resource-intensive reviews that occur every five to 10 years, often creating lags in identifying and addressing quality concerns at ...

To continue reading this content, please enable JavaScript in your browser settings and refresh this page. For midsize enterprises (MSEs), the finance function is ...

New York, NY, and Schaumburg, Ill., USA (26 June 2018) – Today, ISACA and SecurityScorecard announce a joint research paper, “Continuous Assurance Using Data Threat Modeling,” to provide enterprises ...

OVERLAND PARK, Kan., November 19, 2025--(BUSINESS WIRE)--Archer®, a global leader in enterprise compliance and risk management software, today announced new continuous controls monitoring (CCM) ...

To be reaffirmed for accreditation, Miami University must undergo two processes: an assurance and an improvement process. The assurance process requires the creation of an Assurance Argument that ...

"The traditional overhead and a growing number of new, proprietary and inefficient approaches trying to speed up outdated practices must fall to the side to improve cybersecurity outcomes without ...