Event Recap: TraceLink FutureLink Barcelona Conference 2024
TraceLink recently hosted FutureLink Barcelona 2024, their annual European meeting for supply chain participants. Since Europe enacted serialization requirements back…
Perspective
Rightsizing a Business Continuity Program
Many emerging biopharmaceutical companies neglect to develop business continuity plans because they are operating with constrained resources. Even with the…
Perspective
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
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
Drafting SOPs for a Facility that Does Not Exist Yet
When a biopharma company is bringing up a new manufacturing or warehouse facility, there are many standard operating processes/procedures (SOPs)…
Perspective
Managing a Tech Transfer Redesign Post-Acquisition
Managing a Technology Transfer (TT) is often complex, and redesigning an existing TT process even more so. Companies will generally…
Perspective
Last Mile Logistics: How Manufacturers Can Help Ensure Product Integrity for Patients
Last mile logistics, the final leg of the supply chain from distribution centers or pharmacies to the point of administration,…
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
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,…
Perspective
Event Recap: Why is Now the Time for Digital Supply Chain Transformation
Clinical supply professionals are responsible for ensuring that patients on clinical trials receive the right drug at the right time…
IT Roadmaps for Commercial Launch
After spending years researching, developing, and testing innovative drug candidates, emerging biopharmaceutical companies successfully progressing in clinical development begin preparing for…
Enterprise IT Strategies for Life Science
Managing enterprise information technology in emerging and growing Life Science companies is challenging beyond the typical IT dilemma. Emerging biopharma…