Blog Post Life Sciences Quality + Compliance Writing Clear and Actionable Work Instructions for Veeva Vault Users In this piece, we outline key considerations for writing clear and actionable work instructions for Veeva Vault Users. Standard Operating ...
Blog Post Life Sciences Quality + Compliance The Impact of Automation on QC and QA Roles This piece on the impact of automation on QC and QA roles was co-authored by members of Clarkston’s Quality + ...
Case Study Life Sciences Quality + Compliance Executing the Global Deployment of LabVantage LIMS for a Biopharmaceutical Company Clarkston Consulting recently partnered with a biopharmaceutical company on a global deployment of LabVantage LIMS. Read a synopsis of the ...
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 ...