ERP for Medical Device Manufacturers
Reduce Compliance Risk and Scale Operations with Infor ERP
Copley Consulting Group has successfully implemented Infor ERP on behalf of dozens of small- to mid-size medical device manufacturers across the United States. Infor CloudSuite Industrial (Syteline) is a proven single system that helps medical device manufacturers maintain strict quality management and detailed product information, while fulfilling stringent regulatory requirements.
Outcomes Manufacturers Can Expect
One Enterprise Wide System
Eliminating or connecting disparate systems means better control, process automation and scalability
Double-Digit % Cost Reduction
Better control and automation equals time savings and safeguards that significantly reduce costs
Elimination of Compliance Risk
Meet FDA requirements and ISO 13485 certification, and obtain compliance across the U.S. and Europe
100% Paperless Operations
Enjoy efficiencies and save trees thanks to an electronic device record, bar-coded inventory, and much more
Enhanced FDA Compliance Capabilities – Only with Copley
Copley Consulting Group is the only Infor Gold Channel Partner to offer these additional regulatory compliance solutions for medical device manufacturers.
Every record on building and testing a medical device is kept in a device master record. Any material proving your device is compliant is included in the device history file. Keeping your files well organized in an industry-specific medical device ERP system is essential.
Full Lot & Serial TraceabilityLearn More
Full Lot & Serial Traceability
Every component of a medical device is lot traced. The trace functionality starts from the very beginning upon receipt of the material and is tracked to the specific work order that utilizes the traced material and the finished good.
Quality ControlLearn More
Medical device manufacturers need an integrated quality system that is designed to fulfill ISO-certified operations. To stay within FDA guidelines, Infor SyteLine follows a specific focus in processing inspections, non-conformance, and corrective actions.
Approved Vendor ManagementLearn More
Approved Vendor Management
Infor SyteLine keeps records of your entire lifecycle from the idea stage to when it is available for users. When it comes time for an audit you will be expected to show how you manage your suppliers and ensure that the parts you are supplied with are compliant with regulations and meet your specifications.
eSignature ControlsLearn More
The faster you can deliver your products, the better. eSignature Controls help you launch products sooner by increasing the efficiency of your approval and agreement processes, all while supporting your global compliance needs.
CoA & CoC Report for Manufactured LotsLearn More
CoA & CoC Report for Manufactured Lots
CoA & CoC reports document the quality assurance and confirms a regulated product meets the product specification. These contain the actual results obtained from testing performed as part of quality control of an individual batch of a product.
To view entire table scroll right to left using arrows or touch.
Copley offers four implementation service approaches━each with advantages and disadvantages. The right approach is dependent on your organization’s goals and needs.
Our FDA Regulated Clients
Our FDA Regulated Clients
CONTACT US TO
Request A Demo
Triangle Accelerates Growth With Copley’s FDA Extended ERP Solution
Triangle Manufacturing Company Inc. was founded in 1955 and continues to bring to life a wide range of medical instrumentation and implantable devices at a time when reliable sourcing is more important than ever. Triangle’s work impacts almost every part of the human body, demanding a level of precision and quality unlike any industry.
Copley’s FDA Regulated Resources
BionX Medical Technologies
HART (Harvard Apparatus)