The AI Paradox
Cover: The increasing digitalization of the pharmaceutical and medical device industry has created novel cybersecurity challenges, particularly with the rapid advancement of artificial intelligence (AI) technologies. This article examines the dual nature of AI as both a potential threat vector and a powerful defensive tool.
Digital Transformation: Developing a Fully Automated Pharma Manufacturing Facility
Feature: The move to digital transformation represents a true paradigm shift in manufacturing, enabling organizations to leverage advanced technologies such as the Industrial Internet of Things (IIoT), cloud computing, and artificial intelligence (AI) to ensure compliance and secure a competitive advantage. This article presents a working definition of digital trans-formation, the components involved in undertaking a transformation initiative, and a phased approach to implementing digital transformation for the pharmaceutical industry.
A Pharma 4.0™ Future for Brownfield Challenges
Feature: Pharmaceutical companies can use digital maturity assessments to address the challenges of upgrading brownfield facilities and implementing digital transformation improvements. Enabled by stakeholder workshops, these assessments can rapidly produce concrete plans and priorities to guide a facility’s development over the next three to five years—delivering business value and laying the foundation for continuous improvement.
Applying Process Data Mapping Methodology for Systematic and Sustainable Transformation Toward Pharma 4.0™
Feature: Pharma 4.0™ is a reference framework tailored to the pharmaceutical industry, guiding its digital transformation. Although many of today’s processes generate sufficient data to enable advanced use cases, structured guidance for transformation is often lacking. To address this, the ISPE Pharma 4.0™ Subcommittee on Process Data Maps and Critical Thinking has introduced an approach to help organizations develop a holistic perspective on transformation.
Visual Inspection Is Key to Ensuring Patient Safety in US Pharmaceutical Compounded Products
Technical: Visual inspection is nothing new to professionals who make, prescribe, prepare, and/or administer pharmaceutical parenteral products to patients of all backgrounds, especially those who may have immunity concerns. The pharmaceutical industry has tried to ensure that companies enact the best quality standards that are consistent with Current Good Manufacturing Practices (CGMPs) to prevent an adulterated product from entering the market.