Blog Post Quality + Compliance Life Sciences Moving From a LIMS Assessment to a LIMS Deployment Laboratory Information Management System (LIMS) implementations can be challenging due to the cost, commitment of resources, and other competing priorities ...
Blog Post Quality + Compliance Life Sciences Moving from Validation to Computer System Assurance In September of this year, the FDA plans to release guidance on the transition from the traditional concepts of Computer ...
Blog Post Quality + Compliance Life Sciences Why Invest in a Quality Management System (QMS)? Why Invest in a Quality Management System? It’s not uncommon for a small- to mid-sized companies to use a paper-based ...
Blog Post Quality + Compliance Consulting Services How Realistic is the U.S. Importation of Canadian Drugs? On July 31, 2019, the White House announced an iterative healthcare plan that would allow the importation of Canadian drugs ...
Blog Post Consulting Services Pharma What Does Scott Gottlieb’s Exit Mean for the Industry? In March, FDA commissioner Scott Gottlieb announced his resignation, which became effective last Friday, April 5th. Highly regarded by life ...
Blog Post Consulting Services Pharma Drug Pricing Laws at the State and Federal Level Over half of US states have proposed new drug pricing laws and transparency legislation in the past two to three ...
Blog Post Consulting Services Pharma Government Shutdown 2019: Impact to Life Sciences Industry As the U.S. continues to face the government shutdown in 2019, the longest in history, the lack of funding for ...
Blog Post Consulting Services Quality + Compliance Preparing Quality Data for Acquisition Merger and acquisition failure rates continue to rise due to extenuating and spiraling costs post-merger. Misaligned cultures, technologies, and processes ...
Blog Post Consulting Services Medical Device Medical Device Security – Balancing Privacy and Data Accessibility Over the past decade, device security has become a more high-profile topic as medical device manufacturers incorporate next-generation technology to ...
Blog Post Consulting Services Quality + Compliance Building LIMS for the FDA Quality Metrics Reporting Program Increasingly, businesses in the life sciences industry are realizing the lasting effects that data management, integrity, and reporting can have ...
Blog Post Information Technology Quality + Compliance 10 Questions to Mitigate Risk in a Global System Deployment A global system deployment is a large undertaking requiring precision planning and coordination across a multitude of people, systems, and ...
