Medical Device Companies Must Embrace Modern Manufacturing Execution System (MES) Strategies to Future-Proof Their Business By: Sandra K. Rodriguez, Market Analyst FDA’s upcoming guidance on …
New Whitepaper Series – Why MedTech Must Embrace Industry 4.0 Read More »
A Straight from the Source Webinar Available On-Demand FDA is committed to supporting and enabling pharmaceutical innovation and modernization. The Agency recognizes that continuous manufacturing …
FDA Shares Quality Considerations for Continuous Manufacturing Read More »
Hello Computer System Assurance (CSA)! By: Daniel R. Matlis, President and Ellyn McMullin, Research Associate FDA supports and encourages the use of automation systems and digital …
Computer System Assurance in Support of Manufacturing 4.0 By: Daniel R. Matlis, President Computer System Validation (CSA) is a streamlined approach to validation that supports …
eBook: CSA – A Streamlined Approach to Validation Read More »
Webinar Available On-Demand Disruption is on the radar! Life-Science executives must plot a course for success. That was the theme of our “Straight from the …
Disruption is on the Radar! You Must Plot a Course for Success. Read More »
A Straight from the Source Webinar The FDA has recognized that existing perceptions and approaches to computer system validation (CSV) are a significant barrier to …
A Straight From the Source Webinar A disruptive storm is on the Horizon and Life-Science Executives MUST plot a course to success. Join us for a …
An On-Demand Webinar Presented in Conjunction with Kalypso The European medical device industry is undergoing a transformation as the new European Medical Device Regulation is set …
How Electronic Batch Records (EBR) Can Support Quality Metrics By: Sandra K. Rodriguez, Market Analyst Many life science companies have implemented manufacturing information systems as …
White Paper: Stop Managing Paper in a Data-Driven World Read More »
Veeva 2018 Summit Event Brief By: Daniel R. Matlis, President Introduction “We are building the industry cloud for life sciences,” said Peter Gassner, president and …
Veeva is Building the Life Sciences Cloud with High Speed and Velocity Read More »
FDA Issues a Report on Increased Medical Device Inspections and Improved Compliance The Report highlights: Annual device inspections have increased 46% since 2007 The annual …
FDA’s Medical Device Enforcement and Quality Report Read More »
Webinar Now Available On-Demand By: Sandra K. Rodriguez, Market Analyst Compliance with Medical Device Regulation 2017/745/EU also commonly referred to as EU MDR, is presenting …
EU MDR – New Rules Require Greater Traceability, Data Transparency Read More »
