Syteline Medical Device ManufacturingHave your cake and eat it too
Infor® SyteLine ERP for Medical Devices gives you the tools you need to develop, evolve, and thrive in this highly regulated environment.
Enjoy the state-of-the-art technology available at your fingertips without compromising your FDA compliance. SyteLine ERP for Medical Devices provides access to best-of-breed software applications such as Birst analytics, Configure Price Quote (CPQ), Infor Document Management (IDM) and the Ming.le social platform, to name a few, in the cloud while your core system resides on-premise allowing you and your team the luxury of these incredible tools while remaining compliant with the FDA.
With SyteLine ERP for Medical Devices, you get a complete solution for your industry with flexible, hybrid deployment options.
Meet & Maintain Regulatory Requirements
Kick-start the validation process
The operational validation scripts, developed specifically for SyteLine ERP for Medical Devices, can help manufacturers reduce the effort, resources, and risk it takes to meet these stringent requirements. The proprietary protocols available to you in SyteLine ERP for Medical Devices include scripts and best practice templates developed by Shepard Bentley, RAC, QuadKor FDA Regulatory Expert, to help you kick-start and facilitate the validation process.
Use integrated electronic records
Global regulatory agencies, including the FDA, define electronic records as the information created, stored, generated, received, or communicated by electronic means. With electronic records management, this information can be accurately perceived, reproduced, and distributed for further assessment. For medical device manufacturers, this information may be associated with various object types for engineering change management, audit trails, device history records (DHR), device master records (DMR), revision control, quality plans, and a range of other key areas of information management that are associated with FDA compliance.
SyteLine ERP for Medical Devices provides electronic records throughout the medical device manufacturing lifecycle from the creation of digital records through modification, storage, and records submission to FDA. This information includes the printed name of the signor, date, and time stamp, as well as the meaning associated with the signature. Extending the use of electronic signatures beyond specific requirements of the FDA to meet industry standard good manufacturing practices (GMP) further establishes a win-win proposition for medical device manufacturing organizations.
Include Unique Device Identifier (UDI)
As a component of SyteLine ERP for Medical Devices Full Lot & Serial Traceability module, QuadKor offers the means to assist manufacturers satisfy the current FDA requirements for maintaining UDI compliance.
Comply with Cybersecurity requirements
QuadKor maintains a current awareness of FDA compliance requirements and recommendations for the cybersecurity of SyteLine ERP for Medical Devices, ongoingly.
Uphold GMP quality standards
Ineffective enforcement of corrective and preventive action (CAPA) processes in fragmented compliance systems often leads to non-conformance to FDA regulations. To enable FDA compliance, you must integrate CAPA results into the information systems you use for quality planning. This is critical to improving manufacturing processes and leveraging electronic data recording and information management capabilities. Medical device manufacturing companies need this business system functionality to contain costs and tighten product and process control. SyteLine ERP for Medical Devices gives you the tools you need to integrate CAPA results into quality planning, improvement, assurance, engineering, and control. That way you can create a centralized approach to master data management.