Blog Post Quality + Compliance Life Sciences LIMS Implementation: Everything You Need to Know LIMS implementations are often viewed as a challenging journey due to the investment of cost, commitment of resources and competing ...
Case Study Quality + Compliance Life Sciences A Case Study in Operational Excellence in Quality Clarkston was engaged by a clinical-stage biotech company for an operational excellence in quality project. This client is a leading ...
Case Study Quality + Compliance Pharma LIMS “Go Paperless” Project: Digital Transformation The client develops and manufactures pharmaceutical products for a wide range of medical disciplines. Specifically, the Vaccine Research and Development ...
Blog Post Consumer Products Health and Beauty Regulatory Compliance and Data Integrity in Cosmetics As the cosmetic industry continues to develop more advanced technologies to support their products, organizations must fully demonstrate the integrity ...
Blog Post Quality + Compliance Organizational Performance How to Leverage Training to Replace Institutional Knowledge in the Quality Organization As companies face the challenges of a slowdown due to COVID-19, this may be the perfect time to review the ...
Blog Post Quality + Compliance Life Sciences Are You Ready to Upgrade Your Quality Management Systems? Are your aging Quality Management Systems (QMS) and the problems that come with them keeping you up at night? Upgrading your ...
Blog Post Quality + Compliance Life Sciences Moving From a LIMS Assessment to a LIMS Deployment Laboratory Information Management System (LIMS) implementations can be challenging due to the cost, commitment of resources, and other competing priorities ...
Multimedia Quality + Compliance Consumer Products Regulatory Compliance and Data Quality in Consumer Products: Taking Stock with David Patterson and Rob Wojtowicz For Life Sciences organizations, there has never been a debate around the criticality of data quality and regulatory compliance. However, ...
Case Study Quality + Compliance Life Sciences FDA Inspection Readiness for Business Systems Clarkston recently partnered with a biopharmaceutical company on their FDA inspection readiness for business systems project. This company develops, manufactures, ...
Multimedia Quality + Compliance Consumer Products Addressing an FDA Form 483 You are in the middle of an FDA inspection and a significant issue just surfaced. How you handle the situation ...
Blog Post Quality + Compliance Life Sciences Moving from Validation to Computer System Assurance In September of this year, the FDA plans to release guidance on the transition from the traditional concepts of Computer ...
Case Study Quality + Compliance Life Sciences Global QMS Process Redesign In this case study, we describe our partnership with a biopharmaceutical client to help them tackle their global Quality Management ...
