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Medical Expertise
IQMS offers a powerful ERP software solution tailored
to systematically meet the unique challenges of the medical-manufacturing
industry. Customized modules, such as Quality Medical and DHR, exemplify
IQMS’s commitment to addressing the ever-evolving and complex
needs of the industry with solutions that make medical device manufacturers’
jobs easier.
Medical device manufacturers operate in one of the
world’s most competitive and highly regulated industries where
success can hinge on time-to-market and traceability. That’s
why Class 1, 2 and 3 device manufacturers turn to IQMS for advanced
capabilities that help sustain their competitive advantage.
IQMS Quality Medical provides tools and capabilities
necessary to cost-effectively manage compliance with quality issues
while facilitating internal communication and collaboration. This
industry-specific module addresses:
- TS13485 and ISO 9001 standards
- CFR and FDA requirements
- Up-front risk assessment
- Secure electronic signature and document control to comply with
21 CFR Part 11
- Complete audit trail of manufacturing process
- Comprehensive Corrective Action/Preventive Action (CAPA) and
Process/Product PQ functionality
- Non-conforming product review and tracking
The Device History Record (DHR) module allows medical
device manufacturers to cost-effectively:
- Eliminate time-consuming, paper-based tracking systems
- Streamline product development
- Better ensure quality standards compliance
- Gain total visibility and control over the manufacturing process
IQMS’s comprehensive single-source ERP solution
provides a host of critical capabilities needed to succeed, such
as:
- Lot and serial tracking and traceability
- Installation Qualification (IQ) and Operations Qualification
(OQ)
- Warranty and service tracking
- Complaint tracking
- CAD library management
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Overview
