Blog Post Life Sciences Quality + Compliance Considerations for Leveraging AI in GxP-Regulated Environments As artificial intelligence (AI) continues to expand into all sects of technology, pharmaceutical partners may be wondering how such a ...
Case Study Life Sciences Biotech Completing a LabVantage LIMS User Access Configuration for a Biotech Company Clarkston Consulting recently partnered with a biotech company on a LabVantage LIMS user access configuration. Read a synopsis of the ...
Multimedia Quality + Compliance Data + Analytics Key Considerations When Planning Your Clinical Trial Data Migration This piece focuses on the critical aspects of planning and executing data migration when clinical trial management systems (CTMS) or ...
Blog Post Life Sciences Quality + Compliance Adhering to LabWare’s LIMS Basic Coding Standards LabWare LIMS (Laboratory Information Management System) provides a platform for easy configuration using their proprietary coding language, LIMS Basic. It ...
Blog Post Quality + Compliance Consumer Products Developing Consumer-Centric Compliance Strategies to Improve Your Quality Operations With escalating economic and political uncertainty, many companies are adjusting their operations to improve control and enhance agility. Now more ...
Blog Post Quality + Compliance Life Sciences Ensuring DSCSA Serialization Compliance with AI: Opportunities and Challenges The Drug Supply Chain Security Act (DSCSA) is a federal regulation that was passed by the FDA in 2013 in ...
Case Study Life Sciences Quality + Compliance Providing Computer Software Assurance (CSA) Guidance for LIMS for a Cell and Gene Therapy CDMO Clarkston Consulting recently worked with a cell and gene therapy CDMO on providing CSA guidance for LIMS. Read a synopsis ...
Blog Post Consumer Products Quality + Compliance Enhancing Quality Operations in Consumer Products: A Strategic Imperative Amid today’s supply chain uncertainty and volatile geopolitical landscape, companies are having to be increasingly selective about where they focus ...
Blog Post Consumer Products Quality + Compliance Leveraging Lab Informatics in the Wine and Spirits Industry The industry of wine and spirits is changing rapidly. There are many factors impacting this transformation, including product evolution, such ...
Case Study Life Sciences Quality + Compliance Supporting a Serialization and Traceability Program for a Biotechnology Company In this serialization and traceability program case study, Clarkston Consulting partnered with a biotech company to implement TraceLink. Read a ...
Blog Post Quality + Compliance Life Sciences Modernizing Validation in the Life Sciences with Veeva Vault Validation Management In the biotech and pharmaceutical industries, validation activities are essential for maintaining regulatory compliance, product quality, and operational reliability. It ...
Blog Post Quality + Compliance Life Sciences 5 Key Lessons Learned from a Global LIMS Implementation Below, we outline key insights and lessons learned from a global LIMS implementation. Whether you’re considering LabVantage or another LIMS ...
