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 Breaking Down the Changes to 510(k) Clearance On November 26, 2018, FDA Commissioner Scott Gottlieb and Jeff Shuren, Director of the Center for Devices and Radiological Health, ...
Blog Post Consumer Products Quality + Compliance Regulatory Implications of AI Toys The growth of Internet of Things (IoT) isn’t limited to self-driving cars and home security systems. AI toys can already ...
Blog Post Consulting Services Medical Device FDA Clearance of Apple Watch 4 Shows Key Trend in Medical Device Last week, Apple unveiled that it had received FDA clearance for the Apple Watch Series 4, further solidifying one of the top ...
Blog Post Consumer Healthcare Information Technology New Risks of Data Integrity in Consumer Healthcare While business news has been dominated by phrases like big data, data analytics, and data mining, there is one “data” ...
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 LabForward: The Case for Building the Lab of the Future Medicine is changing. Advances in platform technologies and personalized treatments are fundamentally changing the way drugs are discovered, manufactured, and ...
Blog Post Food and Beverage Consumer Products ISO 22000 and the Importance of Food Safety In response to changes to diversity, globalization, and digitization across the industry, the International Organization for Standardization (ISO) recently announced ...
Blog Post Consumer Products Quality + Compliance A Perspective from a Quality Consultant on the Veeva Quality Summit Clarkston recently had the pleasure of attending the 2018 Veeva Quality Summit in Cincinnati. The summit explored the quality imperatives ...
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 Consulting Services Quality + Compliance Serialization Integration with a Pharmaceutical 3PL In an increasingly complex pharmaceutical value chain, integration points between manufacturers and their pharmaceutical 3PLs can be wrought with challenges. ...
Blog Post Medical Device Quality + Compliance Is Your Smartphone a Medical Device? At what point does a smartphone health app enter the medical devices space, triggering oversight by the FDA? As a ...
