Good Automated Manufacturing Practice vs. Computer Software Assurance CSA modernizes and refines GAMP 5 practices to make validation more efficient without compromising system quality or compliance. Jim Macdonell - September 23, 2024 Blogs CMO, Medical Device, Pharma Manufacturing, Quality Assurance
Rethink Your Validation Approach to Drive Innovation Consider the benefits of outsourcing validation & qualification to address the system lifecycle from planning & implementation to retirement. Lisa Om - June 21, 2024 Blogs Biotech, Medical Device, Pharma Information Technology, Quality Assurance
GxP Primer: Where Do Good Practices Come From and Why Do We Need Them? Global health regulators home in on critical requirements for life sciences organizations. Michelle Gardner - June 3, 2024 Blogs Regulatory
Fast-Track Your Journey to Commercialization Fast-track commercialization in life sciences with USDM's GxP expertise, IT strategies, and QMS frameworks for compliance, efficiency, and success. Lisa Om - March 25, 2024 Blogs Biotech Clinical
Transforming Image Data Processing in Biotechnology with High-Performance Computing (HPC) AWS HPC optimized image processing for a biotech firm, cutting costs by 20% and saving over 1,000 hours annually in data management. Rathina Govindaswamy - March 18, 2024 Case Studies Biotech Information Technology, Quality Assurance
A Few Surprises in FDA’s Quality Management System Regulation For most manufacturers, the new QMSR will simplify their approach to quality system compliance. Learn about two important issues to be aware of. Jay Crowley - March 1, 2024 Blogs Medical Device Regulatory
