Improve your processes for developing product offerings Infor CloudSuite™ Industrial (SyteLine) for Medical Devices is built to specifically address the unique requirements of the medical device industry. Created with The Copley Consulting Group as part of Infor’s Micro-Vertical Specialization Program, the solution delivers advanced security, data auditability, electronic recording, and business intelligence capabilities mandated for FDA compliance. At the same time, Infor CloudSuite Industrial for Medical Devices gives you the tools you need to help you mitigate compliance risk, while turning your developmental concepts into commercialized product offerings with greater efficiency. Stay current with the shifting standards of FDA compliance For medical device manufacturers, advancing and maintaining information management solutions that are compliant with an evolving set of FDA regulatory standards is a constant challenge. As you strive to manufacture high-quality medical devices, you need an enterprise resource planning (ERP) solution that can help you minimize compliance risk, as you maintain profitability, drive efficiencies, and streamline all parts of your business. Infor CloudSuite Industrial (SyteLine) for Medical Devices Infor CloudSuite Industrial for Medical Devices gives you the tools you need to develop, evolve, and thrive in a regulated environment. Medical Devices
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Improve your processes for developingproduct offerings
Infor CloudSuite™ Industrial (SyteLine) for Medical Devicesis built to specifically address the unique requirements ofthe medical device industry. Created with The CopleyConsulting Group as part of Infor’s Micro-VerticalSpecialization Program, the solution delivers advancedsecurity, data auditability, electronic recording, andbusiness intelligence capabilities mandated for FDAcompliance. At the same time, Infor CloudSuite Industrialfor Medical Devices gives you the tools you need to helpyou mitigate compliance risk, while turning yourdevelopmental concepts into commercialized productofferings with greater efficiency.
Stay current with the shiftingstandards of FDA compliance
For medical device manufacturers,
advancing and maintaining information
management solutions that are
compliant with an evolving set of FDA
regulatory standards is a constant
challenge. As you strive to manufacture
high-quality medical devices, you need
an enterprise resource planning (ERP)
solution that can help you minimize
compliance risk, as you maintain
profitability, drive efficiencies, and
streamline all parts of your business.
Infor CloudSuite Industrial(SyteLine) for Medical Devices
Infor CloudSuite Industrial for Medical Devicesgives you the tools you need to develop,evolve, and thrive in a regulated environment.
Medical Devices
Previous state
■ Inability to identify improvements inmanufacturing processes
■ Time- and resource-consuming inspectionintrusive to manufacturing process
■ Compliance verification and validation for awide pool of stand-alone systems
■ Fragmented, hybrid compliance systems
■ Isolated functional units
Future state
■ Electronic records and visibility across allmanufacturing processes facilitate trueidentification of compliance standards
■ Real-time inspection
■ Verification and validation of integratedsystems
■ Integrated compliance systems
■ Regulatory compliance enforced with eachquality system and integrated system-basedapproach to compliance
Meet regulatory requirementsInfor CloudSuite Industrial for Medical Devices is delivered in an FDA compliant IT infrastructure. It is deliveredwith well-established protocols and validation scripts developed by The Copley Consulting Group that meetregulatory requirements for computer systems in compliance with the FDA’s 21 CFR Part 11. The latest set of FDArules necessitates compliance from a systems-oriented approach, rather than isolated functional units.
Take a systems-oriented inspectionapproach to FDA compliance
Infor CloudSuite Industrial (SyteLine) for Medical Devices Brochure 2
Maintain regulatory complianceFor medical device manufacturers, business process validation, inclusive of computer software, is a criticalcomponent of maintaining regulatory compliance. While validation ensures the software’s intended use issubstantiated and documented, this process can consume valuable resources, material costs, and expose acompany to the risk of FDA audit non-compliance if not properly executed. Here’s how Infor CloudSuite Industrialfor Medical Devices can help.
Kick-start the validation processThe operational validation scripts, developedspecifically for Infor CloudSuite Industrial for MedicalDevices, can help manufacturers reduce the effort,resources, and risk it takes to meet these stringentrequirements. The proprietary protocols available toyou in Infor CloudSuite Industrial for Medical Devicesinclude scripts and best practice templates to help youkick-start and facilitate the validation process.
Use integrated electronic recordsGlobal regulatory agencies, including the FDA, defineelectronic records as the information created, stored,generated, received, or communicated by electronicmeans. With electronic records management, thisinformation can be accurately perceived, reproduced,and distributed for further assessment. For medicaldevice manufacturers, this information may beassociated with various object types for engineeringchange management, audit trails, device historyrecords (DHR), device master records (DMR), revisioncontrol, quality plans, and a range of other key areas ofinformation management that are associated with FDA compliance.
Infor CloudSuite Industrial for Medical Devicesprovides electronic records throughout the medicaldevice manufacturing lifecycle from the creation ofdigital records through modification, storage, andrecords submission to FDA. This information includesthe printed name of the signor, date, and time stamp,as well as the meaning associated with the signature.Extending the use of electronic signatures beyondspecific requirements of the FDA to meet industrystandard good manufacturing practices (GMP) furtherestablishes a win-win proposition for medical devicemanufacturing organizations.
Uphold GMP quality standardsIneffective enforcement of corrective and preventiveaction (CAPA) processes in fragmented compliancesystems often leads to non-conformance to FDAregulations. To enable FDA compliance, you mustintegrate CAPA results into the information systemsyou use for quality planning. This is critical to improvingmanufacturing processes and leveraging electronicdata recording and information managementcapabilities. Medical device manufacturing companiesneed this business system functionality to contain costsand tighten product and process control.
Infor CloudSuite Industrial for Medical Devices givesyou the tools you need to integrate CAPA results intoquality planning, improvement, assurance, engineering,and control. That way you can create a centralizedapproach to master data management.
Infor CloudSuite Industrial (SyteLine) for Medical Devices Brochure 3
Copley Implementation Accelerator is a packagedset of well-defined deliverables that allow for thesuccessful deployment of Infor CloudSuiteIndustrial for Medical Devices on an aggressivetimeframe. Copley Implementation Acceleratorcan reduce the risk to your budget parametersand go-live expectations by increasing yourtechnology ROI and reducing the downtime foryour critical functions.
Sensitive to GMP practices, CopleyImplementation Accelerator enables us to deliversolutions tailored to your company’s uniquevalidation, quality, compliance, and regulatoryrequirements. The methodology optimizes yourresources and streamlines your implementationprocess, with the flexibility of deploying in thecloud or on-premise while ensuring the samehigh degree of success.
Go-live quickly with Copley Implementation AcceleratorCopley Implementation Accelerator makes it possible for medical device manufacturers to implement InforCloudSuite Industrial for Medical Devices quickly and without major modifications, while still benefiting from thesolution’s flexibility and scalability for long-term, continuous improvement.
Streamline the implementation process
Infor CloudSuite Industrial (SyteLine) for Medical Devices Brochure 4
Learn more about Infor’s solutions formedical device manufacturers.
Infor CloudSuite Industrial for Medical Devices isdesigned, developed, and deployed specificallyto address the nuances of a medical deviceenterprise with:
■ Deep medical device functionality
■ Packaged operational validation scripts
■ Industry knowledgeable consultants
■ Implementation Accelerator package
■ Regulatory compliance
The fluctuating business environment isdangerous enough to manage. Controlling yourbusiness and conforming to strict regulationsshould not add to your challenges. With InforCloudSuite Industrial for Medical Devices, you canreduce these risks and make your businessprocesses more efficient.
Deploy a complete solution for medical device manufacturersFrom managing complex value chains and fast-paced product launches to shortening cycle times and easilymanaging product configurations, Infor gives medical device manufacturers like you advanced functionality that'sbacked by decades of practical application and relied upon by thousands of manufacturing customers worldwide.
With Infor CloudSuite Industrial for Medical Devices, you get a complete solution for your industry with flexibledeployment options, either through a subscription in the cloud or a traditional on-premise license option.
