The Evolving Ecosystem for Biopharma Manufacturing
A significant – even seismic – shift is taking place in biopharma manufacturing and technical operations right now. It is…
Perspective
US-China Trade Tension: Increasing Uncertainty for Biopharma
In recent years, the US government has increasingly leveraged trade policy as a tool for broader U.S. foreign policy. This…
Perspective
Impact of Rejecting Chevron Deference on Biopharma
On June 28, the Supreme Court of the United States (SCOTUS) overruled the most cited legal case in its history, colloquially…
Perspective
ERP Implementations: How to Ensure a Successful Business Go-Live
This series starts with ERP Implementations: Understanding Technical Versus Business Go-Live, which focuses on why it is critical to balance the…
Perspective
ERP Implementations: Understanding Technical Versus Business Go-Live
Many life science companies rely on enterprise resource planning (ERP) to help manage and integrate essential parts of the business.…
Perspective
Transitioning to Computer Software Assurance from Computer Systems Validation
Life science companies need to verify that GxP computer and software systems accurately support their intended business processes. The traditional…
Perspective
Event Recap: Building High-Touch Patient Supply Chains
The healthcare industry is increasing use of patient outcomes as a measure of quality and value. This drives biopharmaceutical companies…
Perspective
Pushing “Fast Forward” on Serialization Requirements: What Manufacturers Need to Do for 2022
Per DSCSA, the U.S. pharmaceutical industry must be exchanging EPCIS data at the serialized package level by November 27,…
Perspective
Personal Information Protection: Broader than You Think
National and state governments are enacting laws to protect personal identifiable information (PII) from use without data subjects’ consent. Additionally,…