As Bio-Pharmaceutical companies look for opportunities to accelerate innovation cycles, the management of products across the complete lifecycle to support continuous improvement is a strategic …
FDA Guidance on ICH Q12 Will Accelerate BioPharma PLM Adoption Read More »
Life-Science companies of all sizes are digitally transforming to improve quality, from raw material to patient, while achieving resilience, effectiveness & efficiency. Hear from Edward …
Driving Digital Transformation in a Connected Eco-System Read More »
An open Letter to the Life-Sciences Industry on Analyst Forced Vendor Rankings By: Daniel R. Matlis As a Life-Science Industry Analyst, I am often asked …
COVID-19 forced Life-Science companies to reimagine the way they operate. Pfizer has adapted its Culture, Systems and Processes to drive increased visibility, control and collaboration …
Pfizer Uses Positive Disruption to Manage Product Design Across the Lifecycle Read More »
An Axendia Insight Brief, Presented by Sparta Systems An effective Quality and Risk Management program enables Life Science manufacturers to proactively manage product quality and …
Improving Product Quality & Patient Outcomes with Integrated QRM Read More »
Disruptions have eroded trust across Life-Science supply chains forcing brand owners to re-evaluate outsourcing programs in favor of Smart-Sourcing strategies that focus on quality, resilience, …
Digital Transformation Builds Trust Across the Value Network Read More »
QbDVision Briefing Note By Daniel R. Matlis The Executive Management team at CherryCircle Software recently briefed Axendia on QbDVision®, its cloud-based Product Quality and Lifecycle …
Improving Process Understanding Across the Product Lifecycle Read More »
Automating Electronic Batch Record review is a key benefit of Modernizing Manufacturing Operations. Yet concerns regarding FDA’s acceptance of Review by Exception (RBE) has prevented …
FDA Debunks Industry Myths on Electronic Batch Records and Review by Exceptions Read More »
Industry must adapt and overcome current and future disruptive trends on the horizon. To assist in this effort, Axendia revealed the 2021 Life-Sciences Radar. In …
The FDA has recognized that current perceptions and approaches to computer system validation (CSV) are a significant barrier to Digital Transformation and Manufacturing Modernization. The …
FDA Shares Insights on Digital Transformation & Manufacturing Modernization Read More »
Selerant Briefing Note By Daniel R. Matlis The Executive Management team at Selerant recently briefed Axendia on its formula-based product lifecycle management (PLM) solution. Founded …
By Daniel R. Matlis Sanmina’s Medical Division manufactures a wide range of products and systems for well known medical OEMs including laboratory, biotechnology, diagnostics, therapeutic, …
Sanmina Medical Embraces Cloud MES To Optimize Manufacturing Read More »
