White Papers & Analyst Reports
- Issues Facing Device Manufacturers as FDA Moves Closer to Mandating Electronic Reporting (eMDR)
- Transitioning from a paper-based system to an electronic reporting platform will require thought, planning, design, testing, and implementation. The purpose of this paper is to help identify many issues which will emerge during the transition process. In this discussion, emphasis is placed on careful upfront thought and planning. Thorough work on these fronts will ensure a smooth design phase, productive testing, and a successful implementation.
- Food and Beverage Manufacturers: Avoid TREAD Act Déjà Vu and get a Grip on Quality Now
- The recent food recalls have intensified the focus on product quality from the supplier, to the shop floor, to the boardroom. In a recent study of 90 food and beverage companies on quality management strategies and architecture, AMR Research found significant business process performance hurdles, with data analysis and corrective and preventive actions (CAPAs) being the most glaring gaps.
Technology Approaches to Quality Management
The presence of software solutions in the quality arena has progressed gradually from a deployment of tactical point solutions to complete, enterprise-level solution offerings.
- Aberdeen Report: The Cost of Quality Benchmarking Enterprise Quality Management 2008
- The process of quality management has evolved significantly over the past several years.
- Creating a Culture of Quality
- For years, the manufacturing industry has been in the midst of a struggle between two opposing forces – supply chain management and supply quality management.
- Enterprise-Level Change Control: A Life Science Business Imperative
- Change control in life science organizations is a critical business issue in terms of risk, safety and business performance - and it cannot be short-changed.
- Why CAPA Still Matters
- Many organizations have yet to adopt an effective closed-loop CAPA management process, and even fewer have implemented a consolidated system for addressing the quality of the processes in place to track and report CAPA issues.