Authenticate and Improve Your Quality Processes
Automating the quality management review process for greater process efficiency:
Quality management reviews (QMRs) are a necessary and valuable process. In fact, life science companies including pharmaceutical, biotech, medical device and diagnostics manufacturers must show proof that quality management reviews have been executed. Manufacturing and service-driven companies that adhere to ISO Standards must also conduct QMRs as well. The AssurX Quality Management Review software demo provides a high-level overview of the solution, including how automation captures and helps guide efficient, results-driven QMRs.
AssurX Quality Management Review software guides compliance with regulations and standards including:
- FDA 21 CFR Part 820 for medical device firms
- International Conference on Harmonisation (ICH Q10 guidance) for pharmaceutical companies
- ISO 13485 for medical device firms
- SO 9001 quality system standards
View the Quality Management review demo and see the benefits:
- Compliance: Provide proof that a quality management system is effective, fit for purpose, and capable of adjusting to changes within the company. In addition, launch and track CAPAs resulting from findings.
- Collaboration: A closed-loop system helps end silos by connecting people, tasks, and processes for greater collaboration across all functional areas contributing to the quality management review.
- Data Integrity: Align with FDA and ISO guidelines that focus on data, documentation and risk-based decisions. Gain immediate access to quality data that can integrate with QMR records.
- Proactive Approach: Automate planning and set expectations in advance. Create detailed agendas with input from all stakeholders to cover all topics (a requirement for FDA and ISO).
- Quality Improvement Effectiveness: AssurX Quality Management Review software allows you to define the most important key performance indicators (KPI). Furthermore, trend analysis can help pinpoint areas that may require changes and appropriate tracking.