What’s New in the GAMP 5 Second Edition? The GAMP 5 Second Edition was published in July 2022. In this blog post, Sparta’s Industry and Business Development Lead, Max Ma, dives into the key updates of the latest edition.
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?
Harnessing the Power of Data Integrity with ALCOA+ Ensure data integrity by following the ALCOA+ principles with the help of a digital quality management system (QMS).
Root Cause Essentials: Using the PDCA Approach to Support Continuous Improvement Studies show that continuous improvement increases productivity, profit, and customer satisfaction and creates less waste. In this blog post, Sparta's Zillery Fortner shows us how the PDCA cycle supports continuous improvement.
The Quality 4.0 Productivity Paradox The EU has published its long-anticipated revised GMP Annex 1 for the manufacturing of sterile drug products.
Finalized: EU Publishes GMP Annex 1 Revision The EU has published its long-anticipated revised GMP Annex 1 for the manufacturing of sterile drug products.
Root Cause Essentials: Unleash the Power of Your Mind with Mind Mapping Mind mapping is a great way to evolve your team's thoughts and bring them to life to spark the creative thought process of finding solutions to problems.
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.
