Blog Post Life Sciences Quality + Compliance Best Practices for Software Validation in Life Sciences Software validation, a standard practice in life sciences quality and compliance, has become even more critically important over the last ...
Blog Post Life Sciences Information Technology Preparing for the Shift from Computer Systems Validation to Computer Software Assurance Let’s explore the differences between Computer Systems Validation (CSV) and Computer Software Assurance (CSA): Tony is a truck driver, and ...
Blog Post Consumer Products Health and Beauty Considerations for Implementing LIMS in the Cosmetics Industry An integrated laboratory information management system (LIMS) can be leveraged to manage laboratory processes, quality control, quality assurance, training, equipment ...
Case Study Supply Chain Biotech Serialization and Traceability Registration for a Biopharmaceutical Organization Clarkston has deep and long-standing experience working with pre-commercial life sciences companies, and the challenges of transitioning – and in ...
Blog Post Life Sciences Data + Analytics Scientific Data Management System (SDMS) For Laboratory Operations As companies build toward having a “Laboratory of the Future,” one of the major areas of non-compliance involves instrument files. ...
Blog Post Quality + Compliance Consulting Services Key Considerations for a LIMS Vendor Selection Selecting the best Laboratory Information Management System (LIMS) for your business is a process that should be approached with careful ...
Blog Post Consumer Products Food and Beverage Using Innovative R&D Technologies in the Food and Beverage Industry Consumer preferences are ever changing and evolving, and it’s up to consumer products organizations to quickly adapt and respond: R&D ...
Blog Post Consumer Products Consumer Healthcare The Switch from Rx to OTC The pharmaceuticals industry continues to experience shifts from prescription medications to over-the-counter (OTC) drugs, with the FDA executing over a ...
Blog Post Quality + Compliance Data + Analytics An Introduction to Scientific Data Management Systems (SDMS) Laboratory Information Management Systems (LIMS) can become even more efficient with the introduction of one particular subs-system, Scientific Data Management ...
Multimedia Quality + Compliance Consulting Services Successfully Transitioning to an EQMS A quality philosophy that focuses on a business approach to compliance versus a compliance approach to business is key to ...
Blog Post Life Sciences Pharma The Challenge at the Final Mile of DQSA When the Drug Quality and Security Act (DQSA) was passed in 2013, it mandated that full compliance with electronic data ...
Case Study Quality + Compliance Biotech Organizational Change Management for Global Veeva Implementation This client develops and produces treatment for life-threatening diseases around the world. In addition to antiviral and antiretroviral therapy used ...