Today’s Medical Device Mandate: Quality, Compliance and Continuous Improvement
You need unprecedented agility to succeed in today’s medical device industry. You need to address a myriad of business challenges including stringent regulatory oversight, significant recall exposure, increasingly complex devices, shorter market windows and relentless global expansion and competition.
However, current systems fall short of meeting today’s most important challenges:
- Defining and institutionalizing appropriate production and process controls, corrective and preventive actions, and device history record mechanisms
- Reducing the high cost of compliance while improving quality
- Reducing time-to-market while preventing significant product recalls that can wipe out profit margins
- Supporting multi-site, multi-company 24x7 operations
- Providing visibility into operations across sites and supply chain partners, while consolidating multiple IT systems
The Solution for Today’s Medical Device Industry
FlexNet® empowers you to track, trace and control all elements of supply network operations both within your company and across your global supply chain. FlexNet is 21 CFR Part 11-compliant and extends the value of your ERP and other business planning systems through tightly integrated execution solutions for manufacturing, supply chain visibility, quality assurance, time & labor, logistics and regulatory compliance. And, it’s all built on a unified data model. You can implement solutions individually or as an entire suite reducing your IT costs even more by consolidating disparate execution systems.
Combined, these capabilities deliver a broad range of compelling benefits:
- Reduces the cost of compliance and quality
- Improves production and process control
- Reduces recall costs and exposure
- Increases operational and manufacturing efficiency
- Increases customer satisfaction and responsiveness
- Simplifies and rationalizes IT infrastructure
- Speeds time-to-volume production
- Reduces validation cost
Leading Medical Device Manufacturers Choose FlexNet
Winning in medical device manufacturing means being able to simultaneously manage quality, compliance, efficiency and responsiveness. Only FlexNet delivers a comprehensive operations execution solution that offers visibility and control over every link in your supply chain in order to:
- Enable effective compliance with cGMP requirements of 21 CFR Parts 210, 600, 620, and 820
- Provide Electronic Device History Records (eDHR), Electronic Batch Records (EBR), and improved recall management
- Integrate quality management with manufacturing
- Provide full supplier quality management
- Manage labor and operator certifications
- Optimize warehouse and logistics management
- Support enterprise performance management through real-time manufacturing business intelligence
- Provide maximum adaptability with a process-based platform
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