Integrated Document Management: Leveraging Technology to Improve Compliance and Efficiency Quality is essential for manufacturers in regulated industries, such as Life Sciences, to ensure the safety and efficacy...
Document Management: Communication with Regulators Document management technology can be used by manufacturers in regulated industries, such as Life Sciences, to aid their...
Document Management: A Tale of Two Manufacturers Experiences from two TrackWise Digital customers, Arbor Pharmaceuticals and Mikart, Inc., highlight the challenges that companies can face...
Document Management Systems: Risks and Solutions Document management is the process of creating, storing and controlling documents that are related to the quality of...
Reflecting on World Quality Week The theme of this year’s World Quality celebration is Quality Conscience: Doing the Right Thing. In today's newsletter, Sparta reflects on World Quality Week with valuable resources and key insights on quality from customers. We also want to know—what does quality conscience mean to you?
5 Steps to Performing an Effective Root Cause Analysis Conducting a root cause analysis (RCA) is an essential problem-solving method used to isolate and identify concerns. RCA goes beyond simple cause and effect to identify failure points in a process or system.
Post-Market Surveillance: UDI Compliance for Class I Devices Moves Forward with New Deadline The FDA established the UDI system to identify medical devices sold in the United States from manufacturing through patient use, which would ultimately modernize post-market surveillance.
Uncovering the Root Cause and Overcoming Challenges Along the Way Root cause analysis (RCA) is the process of drilling down to find the causes of the problem so corrective and preventive action can be taken.
Shaping the Future of Quality at the RQA Virtual European QA Congress "Transformation is a dramatic change. It is an alteration. It is not doing the same thing we did thirty years ago but now using a computer."