ERP For Medical Device Manufacturers
Manufacturers in the medical device and instrument industry are challenged with a variety of regulatory compliance and government mandated requirements that add cost and risk to their business. They must maintain strict quality management and detailed product documentation to meet customer specifications and regulatory requirements.
Special production techniques, materials, and packaging for medical products force companies to keep stringent control over engineering and shop floor operations. The ability to create detailed work orders and access real-time data instantly is critical to production. Manufacturers need accurate, reliable information about operations, device histories, and costs.
Infor SyteLine ERP for Medical Device Manufacturers is a comprehensive software solution that includes the manufacturing, inventory control, and quality assurance capabilities needed by companies to succeed in this industry. Infor SyteLine ERP helps you bring products to market more quickly, as well as track and manage after-market maintenance and service, while allowing you to manage FDA validation scripting, use electronic signatures, and comply with Title 21 CFR (Code of Federal Regulations).
40+ Years of Exceptional Service for Manufactures
A Top Choice ERP Software For Top Medical Industry Enterprises.
Infor is a leading provider of business software and services, helping over 70,000 customers in 194 countries improve operations and drive growth.
Infor customers include:
- 10 of the top 10 pharmaceutical companies
- 19 of the top 20 U.S. Hospitals
- 12 of the top 13 High Tech Companies
- 43 of the top 50 Industrial Distributors
- 21 of the 25 largest US health delivery networks
With Infor SyteLine ERP, your company can track the movement of materials and parts from receipt to shipping and ensure that products meet or exceed the standards required by customers and by regulatory agencies. Using Infor SyteLine ERP, you can access files quickly for informed decision making, analyze in-depth reports, manage costs and data, and monitor business processes. Lean manufacturing features ensure you deliver on-time while Infor SyteLine ERP’s integrated quality management system helps you easily collect, control, and analyze product data.
Key Features of SyteLine ERP for Medical Devices Manufacturing
This ERP solution is designed and built to meet the requirements of the medical device industry out of the box, you will require fewer modifications, making implementation time quicker and a faster return on investment.
Significantly improve production and profitability:
- Shop Floor Control
- Cost Accounting (Standard, Actual, or Average)
- Multi-Currency Accounting
- Engineering and PLM
- Material Requirements Planning (MRP)
- Combined Bill of Materials and Routing
- Lot and Serial Number Traceability
- Device History Record
- Help Desk/Customer Complaint Tracking
- Return Material Authorizations (RMAs)
- Quality Management
Stay compliant with FDA quality regulatory programs:
1: Case for Quality (CFQ)
The FDA’s Case for Quality regulations focus on data transparency.
2: FDA CFR 21 Part 820
FDA CFR 21 Part 820 is a quality systems regulation the FDA uses to ensure that there are controls and documentation systems for a medical device’s entire product lifecycle—from design, engineering, and manufacturing, to shipment and after-sales service.
3: Quality System Regulation (QSR)
The FDA developed Quality System Regulation (QSR) standards to regulate good manufacturing processes (GMP) for medical device manufacturing.
4: ISO9001, ISO9002, ISO13485 and EN46001
Standard quality regulations that medical device manufacturers must meet.
5: 21 CFR Part 11
21 CFR Part 11 helps companies demonstrate that electronic records are verified, controlled, and generally certified as audit worthy by means of electronic signatures.
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