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. 0 Jay Crowley - March 1, 2024 Blogs Medical Device Regulatory
Best Practices for Complaint and Adverse Event System Implementation Guidance for data management and system implementation for complaints handling 0 Jim Macdonell - January 3, 2024 Blogs Biotech, CMO, CRO, Medical Device, Pharma Quality Assurance, Safety
Rethink Your Validation Approach to Drive Innovation Consider the benefits of outsourcing validation & qualification to address the system lifecycle from planning & implementation to retirement. 0 Michelle Gardner - September 21, 2023 Blogs Biotech, Medical Device, Pharma Information Technology, Quality Assurance
Why Integrated GxP Compliance is More Progressive than Traditional Managed Services Learn why defining and measuring value helps to provide a trusted solution that responds to changes and scales to meet your needs. 0 Michelle Gardner - September 21, 2023 Blogs Biotech, Medical Device, Pharma Information Technology, Quality Assurance
QC Compliance Managed Services for a Global Biotech Company Global biotechnology company required assistance with a comprehensive enhancement of its laboratory systems across multiple sites worldwide. 0 Lisa Om - September 19, 2023 Case Studies Biotech Information Technology, Quality Assurance
Discover a next-generation business model that drives tangible business outcomes Outcome-based next-generation business models empower Quality teams to be proactive in minimizing risk and ensuring regulatory compliance. 0 Michelle Gardner - September 6, 2023 Blogs Biotech, Medical Device, Pharma Quality Assurance
