Medical ERP & MES Systems
Reduce Risk & Improve Compliance, Quality & Traceability
IQMS has decades of industry experience behind its powerful medical ERP & MES Systems software solution, which is tailored, from its very foundations, to meet the unique challenges of Class 1, 2 and 3 medical device manufacturers.
Medical manufacturers operate in one of the world’s most competitive and highly regulated industries where success often hinges on time-to-market and traceability. As such, IQMS recognises that ISO and FDA compliance, quality and enterprise-wide traceability are critical success factors, EnterpriseIQ’s comprehensive functionality supports the dynamic and complex needs of the industry.
IQMS' fully integrated medical device quality management module promotes enterprise-wide visibility and accountability. Industry specific functionality includes:
- Eliminate paper-based Device history record (DHR) tracking
- Address compliance with both ISO13485 and ISO9001
- Manage CFR and FDA compliance requirements
- Comply with 21 CFR Part 11 by capturing electronic signatures and secure document control
- Risk assessment upfront and complete manufacturing process audit trails
- Comprehensive corrective and preventive actions (CAPA) and process / product PQ functionality
- Manage complex product lifecycle management effectively and efficiently
With IQMS you get a single environment for all your ERP, manufacturing, MES and supply chain requirements delivered through one set of tables in an embedded Oracle database. All transactions and events are updated instantly throughout the entire system in real-time. As one, comprehensive and unified ERP system, EnterpriseIQ eliminates the need for multiple, disparate systems and the associated costs of integration, support and maintenance.
Benefits to your medical device manufacturing business
- Designed and developed specifically for Class 1, 2 and 3 medical device manufacturers
- Manage medical device compliance and quality with confidence
- Fully integrated and seamless track and trace
- Product identification and serialisation
- Installation qualification (IQ) and operations qualification (OQ)
- Eliminate unplanned and unnecessary downtime
- Deliver accurate and real-time scheduling and planning
- Minimise inventory costs and maximise plant floor throughput
- End-to-end supply chain tracking and traceability
- World class infrastructure for managing growth and changes to your business.
Proximity is a certified IQMS reseller and provides IQMS implementation services across the UK, Ireland and Europe.