Blog Post Quality + Compliance Medical Device Replacement of Title 21 CFR Part 820 with ISO 13485-2016 The wait and suspense for the United States Food and Drug Administration’s (FDA) plans to harmonize and modernize the way ...
Blog Post Quality + Compliance Organizational Performance A Culture of Quality: The Strongest Foundation for QMS Investments The benefits of a quality management system (QMS) to an organization are generally well understood among quality professionals today. Using ...
Case Study Retail Consumer Products CCPA Compliance: Data Protection and Privacy Clarkston Consulting recently partnered with a global retailer to achieve CCPA compliance. The client owns and operates a chain of ...
Multimedia Quality + Compliance Life Sciences Managing LIMS Data Integrity LIMS data integrity not only impacts the efficacy and efficiency of the LIMS platform, it has cascading effects on regulatory ...
Multimedia Quality + Compliance Life Sciences Achieving LIMS Design Optimization A strategic approach to LIMS design is critical to realize the full benefits of any LIMS platform. Not only will ...
Blog Post Quality + Compliance Pharma 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 Quality + Compliance LIMS: The Center Piece of the Laboratory Digital Transformation Many life sciences companies are embarking on a laboratory digital transformation journey and are using a LIMS solution to help them reach their destination. In order to ...
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 ...