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 Quality Best Practices: Strengthening SOP Maturity Clear standard operating procedures (SOPs) are essential to the successful operation of an organization in order to create consistency in ...
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 ...
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 ...
Case Study Quality & Regulatory Life Sciences 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 Organizational Performance Quality & Regulatory Quality Operations Best Practices: Strengthening SOP Maturity Clear Standard Operating Procedures (SOPs) are essential to the successful quality operations of an organization in order to create consistency ...
Blog Post Quality & Regulatory 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 ...