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"Plex Online provides a turnkey manufacturing ERP software solution for medical device manufacturers with a specific focus on comprehensive CAPA functions, supplier quality management, traceability and more.Plex Online's integrated Quality Management System, Compliance Module, and Document Management System are especially useful in meeting the complex regulatory requirements of medical device manufacturing, including 21 CFR Part 11."
Source: Plex Systems
Five Must-have ERP Features for Medical Device Manufacturers
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At a Glance
- This paper summarizes the five features a medical device manufacturer must have in its ERP software.
- Benefits of an integrated ERP solution include comprehensive supply chain management, precise production tracking and visibility, electronic document management, and more.
- By obtaining all of the features it must have in one Software as a Service (SaaS) solution like Plex Online, a medical device manufacturer will optimize the performance of its entire enterprise.
In the medical device manufacturing industry, errors can cost more than money — they can cost lives.
In order to meet the many complex government regulations spawned by this safety imperative, medical device manufacturers are turning more and more frequently to innovative software solutions. Today's leading ERP solutions go beyond the historical ERP strengths of finance and accounting to help organizations achieve complete process visibility — enabling them to comply with the documentation, safety controls, quality management, and traceability requirements of regulations such as FDA regulations 21 CFR 820 Quality System Regulation (QSR) and 21 CFR Part 11, along with ISO regulations ISO 9001 and ISO 13485:2003. Not only do today's solutions help manufacturers meet these mandates, they enable the highest levels of quality, productivity and profitability.
Bringing the Best ERP Solution to the Medical Device Industry
Today's ERP software can capture data, validate manufacturing processes, ensure product specifications are met, and provide rapid access to that information. Let's face it — a mistake that leads to a Form 483 letter from the FDA can cause enormous harm to a company, in some cases leading to complete shut-down. The fact that these advanced software products are available and improving all the time is good news for medical device manufacturers.
Plex Online is recognized as the No. 1 ERP solution for manufacturers*. Alone among the leading ERP solutions for medical device manufacturers, Plex Online provides all five of the features manufacturers must have in their ERP systems.
Five Must-Have Features
1) Accessible, Real-Time Information
In order to meet government mandates, medical device manufacturers must have quick and easy access to all data related to all of their products, at all times.
Plex Online provides a complete trail of critical data about a medical device manufacturer's products, including details regarding specific materials used, processes performed, suppliers used, operator training, quality test results, and more. Real-time, accurate, and accessible data is available to all users at any time through simple Internet access. Every department accesses the same information. Plex Online provides a single version of the truth - and provides the necessary audit trails to prove it.
"Plex Online provides all five of the features manufacturers must have in their ERP systems."
2) Integrated Solution
Medical device manufacturers cannot afford the inconsistency and confusion that can result if different software systems manage different parts of their operations. They simply must have an integrated manufacturing solution where data is linked across all functions, enabling 100 percent accuracy and consistency. For example, a standalone quality management system is no longer an acceptable deployment model; quality data must be an integral part of the ERP system.
Plex Online provides fully integrated functions for every area of the manufacturing enterprise: Manufacturing Operations Management (MOM) and Quality Management Systems (QMS) for the shop floor, Supply Chain Management (SCM) for procurement, and Enterprise Resource Planning (ERP) for finance and management. Plex Online's fully integrated model delivers a ''shop floor to top floor" view of a manufacturer's operations, enabling medical manufacturers to run their businesses at maximum efficiency.
3) Integrated Quality Management and Supplier Management
The ERP system used by medical device manufacturers must enable the company to meet specific requirements for verification of the effectiveness of corrective and preventive actions (CAPA). For implantable and sterile medical devices, the system must enable compliance with additional ISO 9001 requirements for inspection, traceability, documentation, and validation of processes.
In order to fully manage quality and track all data related to all of their products across the entire supply chain, today's medical device manufacturers must have an ERP system that provides detailed historical information related to production, inspection, genealogy, and usage - and all data must be available at a moment's notice. The system must collect and manage a variety of data from a broad range of internal sources including parts lists, process routings, bills of material, part specifications, process flow charts, failure mode and effects analyses (FMEAs), control plans, check sheets, operator training, and process instructions - including change controls, and full audit trails.
Plex Online has the industry's most comprehensive quality management and supply chain management functionalities. It has the capabilities needed by medical device manufacturers to manage problem controls, cost recoveries, traceability, statistical process controls, issues management, and more. Its compliance monitoring functionality has additional features that enable comprehensive internal and supplier auditing.
4) Production Tracking and Visibility
The days when product recalls took weeks to implement are long gone. Today, the ERP system used by medical device manufacturers must have core track and trace capabilities built right into the inventory management system. The system must include integrated traceability features that accurately track individual containers or pieces as they flow through the manufacturing process so manufacturers can quickly pinpoint and isolate problems with precision, and quarantine any problem products immediately.
Plex Online is the ERP system solution that best meets these needs. It includes serialized container and individual part tracking, built-in barcode printing and scanning, RFID, direct part marking, and detailed container-to-container traceability both upstream and downstream through production to shipment. Users are able to click a button and see what lot of source material was used for a specific part or assembly, who the machine operator was, etc., at any moment on any day since the system was implemented. The click of another button shows all other products potentially affected by the same root cause.
5) Electronic Document Management
Government regulation 21 CFR Part 11 requires that medical device manufacturers maintain electronic records that catalog all key manufacturing data and processes. In order to easily comply with this requirement, medical device manufacturers need ERP software systems with complete electronic document management capabilities.
Not only do these capabilities help medical device manufacturers meet the letter of the law, they create a paperless environment which saves employees time, speeds up overall operations, and reduces room for human error.
Plex Online enables medical device manufacturers to produce and attach electronic files in any format — jpg, Word, Excel, pdf, or any other format requested by the customer — to sales orders, item masters, purchase orders, or accounting transaction files. Additionally, all revisions of these documents are controlled in a Document Management System, for a complete product history record.
"Quality data must be an integral part of the ERP system."
Getting What You Must Have
A flexible, Internet-based solution such as the industry's No. 1 ERP manufacturing solution, Plex Online, brings medical device manufacturers all five of the features they must have to meet compliance requirements, produce the highest-quality products, operate efficiently, and maximize their profitability.
In addition, because it utilizes the SaaS delivery model, Plex Online enables the entire enterprise to avoid costly licenses, complex hardware and software infrastructures. Its customers use the Internet to access systems that are deployed and maintained off-premise. They enjoy ease of use as well as industry-leading security and connectivity. And perhaps best of all, they never need to suffer from using an outdated system, or fear losing customized functionality in the next upgrade. With Plex Online, all users are always on the most up-to-date version of the software, and new features and functions are made available on a daily basis.
About Plex Online
Plex Online, built on a "Software as a Service" (SaaS) model, offers more than 35 0 functional modules, providing manufacturers instant access to vital information and management functions using a simple Web browser. The on-demand solution features product lifecycle management (PLM) functions such as program and change management, enterprise resource planning (ERP) functions such as accounting and finance modules, customer relationship management (CRM) features such as order entry and tracking, manufacturing execution systems (MES) functions such as production scheduling and machine integration and supply chain management (SCM) functions such as supplier quality and traceability.