At ComplianceQuest, we’ve worked with 100+ customers in the medical device ecosystem, helping them adopt a next-generation EQMS for their quality management workflow.
Thanks to this experience, we believe the following 7-step approach will be really helpful for quality leaders at medical device companies, who’re just embarking on the digital transformation journey of their quality processes:
- Step 1: Understand the regulatory landscape
- Step 2: Design your Quality & Compliance Process
- Step 3: Benchmark against industry best practices
- Step 4: Design standard operating procedures
- Step 5: Create a Master Quality & Regulatory checklist
- Step 6: Quality Analytics to derive insights from Quality Data
- Step 7: Continuous Improvement
In this blog, we focus on how medical device quality leaders must leverage and take advantage of quality analytics to derive insights and enable better decision-making
Quality Analytics for Deriving Insights from Data stored in a Medical Device QMS
Having an enterprise-wide automated quality management system provides medical device manufacturers access to data from across functions. This is a goldmine that can be used to understand trends, problem areas and forecast the future for improvement and devising business strategies.
Gold Source of Quality Data
A good EQMS is a data mine that can validate and authenticate data collected, organized and stored in a database with a dashboard for reports. Data modelling tools can help identify bottlenecks to quality and even give a direction for appropriate solutions.
- A customized dashboard for every function,
- An early warning system for potential problems,
- Up-to-the-minute information,
- A consolidated view across the systems,
- An easy to use, drag and drop report builder,
- Integrated security to control access to data based on requirement and authorization,
- A robust reporting schedule,
- Generation of customized reports, and
- Collaborative feedback
At ComplianceQuest, we leverage Salesforce’s Einstein Analytics with out-of-the-box reports and dashboards that lets you tailor your reports and dashboards to suit your needs.
It plays a critical role in using next-generation AI and data analytics to make informed, data-backed decisions in real-time.
In this Whitepaper, we share “A 7-Step Guide to Quality & Compliance for Medical Devices Companies” based on ComplianceQuest’s experience of serving 100+ customer customers in the medical device space.
Read it here: http://www.compliancequest.com/whitepaper/a-7-step-guide-to-quality-compliance-for-medical-devices-companies/