Blog Post Quality + Compliance Life Sciences Are You Ready to Upgrade Your Quality Management Systems? Are your aging Quality Management Systems (QMS) and the problems that come with them keeping you up at night? Upgrading your ...
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 ...
Multimedia Quality + Compliance Consumer Products Regulatory Compliance and Data Quality in Consumer Products: Taking Stock with David Patterson and Rob Wojtowicz For Life Sciences organizations, there has never been a debate around the criticality of data quality and regulatory compliance. However, ...
Case Study Quality + Compliance Life Sciences FDA Inspection Readiness for Business Systems Clarkston recently partnered with a biopharmaceutical company on their FDA inspection readiness for business systems project. This company develops, manufactures, ...
Multimedia Quality + Compliance Consumer Products Addressing an FDA Form 483 You are in the middle of an FDA inspection and a significant issue just surfaced. How you handle the situation ...
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 ...
Case Study Quality + Compliance Life Sciences Global QMS Process Redesign In this case study, we describe our partnership with a biopharmaceutical client to help them tackle their global Quality Management ...
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 ...
Article Pharma Quality + Compliance Drug Supply Chain Impact Due to COVID-19 The global outbreak of the Coronavirus Disease (COVID-19) and its impact both socially and economically across the world’s continents has ...
Multimedia Consumer Products Quality + Compliance Risk Management: Taking Stock with David Patterson Welcome to Taking Stock, a podcast designed to discuss some of the most pressing issues facing corporate executives. This podcast series is ...
Blog Post Biotech Pharma FDA Gene Therapy Guidances: The Latest Updates Explained On January 28, 2020, the highly anticipated final FDA gene therapy guidances were released. In total, 7 guidance documents were ...
Blog Post Sales + Marketing Consumer Products 1 Month Until CCPA Goes Into Effect, Is Your Business Prepared? California’s Consumer Privacy Act (CCPA) will go into effect in 1 month. Why is it important and why should direct-to-consumer, ...
