Blog Post Quality + Compliance Life Sciences Developing QMS Metrics to Share With Your Leadership Team When organizations implement metrics, there is often the urge to track and trend any and every data point. The presence ...
Blog Post Life Sciences Quality + Compliance When to Invest in a QMS Deciding when to invest in a QMS (Quality Management System) can be a time-consuming endeavor. It’s important to choose the ...
Blog Post Quality + Compliance Life Sciences Considerations for Selecting a Quality Management System (QMS) Software Choosing the right Quality Management System (QMS) software can change the way organizations do business. At times, organizations are quick ...
Blog Post Life Sciences Data + Analytics Who Do You Need on Your Quality Systems Team? A quality system (QS) consists of processes that are implemented and documented to ensure that product quality is reproduceable, consistent, ...
Blog Post People + Change Life Sciences A Disciplined Approach: Change Management for Regulatory Compliance Change management is defined in ICH Q10 as a systematic approach to proposing, evaluating, approving, implementing, and reviewing changes. A disciplined ...
Blog Post Quality + Compliance 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 + 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 Life Sciences Cell and Gene Therapy Simplify The Supply Chain for Your Cell Therapy Products Many new cell therapy products are currently in development that are classified as personalized medicine. One subset of that group ...
