Blog Post Quality + Compliance Medical Device What You Need to Know About Recent FDA Guidance on Firm-to-HCP Communications Regarding SIUU On January 7, 2025, the Food and Drug Administration (FDA or Agency) announced the availability of a final guidance for ...
Blog Post Life Sciences Quality + Compliance LIS vs. LIMS: What’s the Difference? Laboratory Information Systems (LIS) and Laboratory Information Management Systems (LIMS) serve important purposes in laboratories. The foundational difference between LIS ...
Blog Post Life Sciences Quality + Compliance Evaluating SDMS Vendors: How to Find the Best Platform for Your Life Sciences Organization As companies look to stay competitive and efficient, they’re increasingly turning to sophisticated technologies that support these goals, like SDMS. ...
Multimedia Quality + Compliance Life Sciences Ensuring a Successful QDMS Implementation and Data Migration A well-structured assessment phase and data migration plan is essential for a successful QDMS implementation and data migration. Following the ...
Case Study Life Sciences Quality + Compliance Implementing LabVantage LIMS for a Seamless TSA Exit Strategy for a Biopharmaceutical CDMO Clarkston Consulting recently partnered with a Contract Development and Manufacturing Organization (CDMO) client on a LIMS and TSA exit strategy. ...
Blog Post Life Sciences Quality + Compliance Understanding the Relationship Between the Metaverse and LIMS Curious about the relationship between the metaverse and LIMS? The life sciences industry has started to leverage novel technologies like ...
Case Study Life Sciences Biotech Establishing a Data Integrity Governance Program for a Biotech Company Clarkston Consulting partnered with a biotechnology company to enhance their data integrity governance, addressing significant challenges and ensuring compliance with ...
Blog Post Life Sciences Quality + Compliance Top LIMS Insights from 2024 As the new year commences, I’ve highlighted some of our top LIMS insights from 2024. Produced by leading industry experts, ...
Blog Post Quality + Compliance Medical Device PCCP for AI: The FDA’s Latest Guidance on AI in Medical Devices On December 4, 2024, the Food and Drug Administration (FDA) announced a final guidance entitled “Marketing Submission Recommendations for a ...
Blog Post Life Sciences Quality + Compliance Top Veeva Insights from 2024 Over the last several years, Veeva has continued to develop and bring to market innovative, cloud-based solutions to address the ...
Blog Post Life Sciences Quality + Compliance 4 Laboratory Execution System (LES) Best Practices in LabVantage LIMS Laboratory Execution Systems (LES) can be a valuable addition to an existing LabVantage Laboratory Information Management System (LIMS). For it ...
Case Study Life Sciences Biotech Transitioning from CSV to CSA for a Biotechnology Company Clarkston Consulting recently partnered with a biotechnology client in their transition from CSV to CSA. Read a synopsis of the ...
