Case Study Life Sciences Quality & Regulatory Application Managed Services Provider Infrastructure Qualification Project Clarkston recently partnered with a client that is a biopharmaceutical company developing, manufacturing, and marketing regenerative biologics utilizing human placental ...
Blog Post Quality & Regulatory Consumer Products Preparing for an ISO Audit An ISO audit can feel like a daunting task but one that’s well-worth the challenge as gaining ISO9001 or ISO13485 ...
Blog Post Quality & Regulatory Consumer Products Extending the Life of Your Aging QMS Your aging quality management system (QMS) and the problems caused by it are keeping you up at night. You would ...
Blog Post Quality & Regulatory Life Sciences 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 & Regulatory 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 Life Sciences Quality & Regulatory 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 Life Sciences Quality & Regulatory 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 & Regulatory Life Sciences 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 Quality & Regulatory 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 ...
Blog Post Life Sciences Quality & Regulatory 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 & Regulatory 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 ...
