Case Study Life Sciences Data + Analytics Conducting a Data Quality and Integrity Audit for a Biopharmaceutical Company Clarkston Consulting recently partnered with a biopharma client on a data quality and integrity audit. Read a synopsis of the ...
Blog Post Quality + Compliance Life Sciences Top Quality + LIMS Insights From 2023 As 2023 reaches its conclusion, I’ve spent time revisiting the large volume of content pieces and critical insights that our ...
Multimedia Quality + Compliance Life Sciences Five Steps for Process Mapping in Quality It’s critical to have a good understanding of the processes used within your company, but how do we best document ...
Blog Post Life Sciences Quality + Compliance Three Capabilities of Batch Release Functionality in SAP From a quality and supply chain perspective, the SAP batch release process is key to ensuring the timely and accurate ...
Blog Post Life Sciences Supply Chain FDA Announces DSCSA 2023 Deadline Extension The FDA recently announced a one-year delay in enforcing the electronic tracking requirement under the Drug Supply Chain Security Act ...
Blog Post Quality + Compliance Life Sciences Leveraging a LIMS Solution for Cell and Gene Therapy Data Management Research in CGT (cell and gene therapy) involves patient care and instrumentation information, which makes data in this sector intensive. ...
Blog Post Life Sciences Quality + Compliance Lessons Learned from a Non-GxP Learning Management System Implementation A Learning Management System (LMS) focused on non-GxP (good practice) professional development learning has the potential to be a huge ...
Multimedia Quality + Compliance Medical Device Applications of Generative AI for Product Quality and GxP Compliance Generative AI is a type of artificial intelligence that can create new content based on existing content or data. The algorithm ...
Blog Post Quality + Compliance Life Sciences Ensuring Password Manager Compliance and Security in Life Sciences The use of password managers to create, store, and reuse passwords across different systems and applications has gained popularity in ...
Case Study Quality + Compliance Biotech Quality Systems and Quality Culture Assessment Clarkston recently partnered with a client on a quality culture assessment project. This client is a leading global pharmaceutical company ...
Blog Post Life Sciences Quality + Compliance Quality 4.0 and the Future of Quality Management Quality management has come a long way since the days of simply inspecting finished products for defects. With the advent ...
Blog Post SAP + Technology Quality + Compliance Key Considerations for an MES Vendor Selection In this series of blog posts, Lynette Nazabal, Client Solutions Executive, explores the strategic decisions you need to make when thinking ...