The Medical Device industry is one of the fastest-growing sectors in our economy
SAM ERP2 is a high-tech solution designed by Centro Software for complete, integrated management of the complex needs of businesses operating in the Medical Device industry.
All processes are managed in full compliance with the relevant regulations, including EU GMP, Annex 11, US FDA- Code of Federal Regulations, Title 21, part 11 (21 CFR Part 11), etc..
The SAM ERP2 system includes management of advanced logistics with the support of INDICOD "UCC/EAN-128" "SSCC" standards, and is an essential tool for validating production process quality for all products involved in the integrated supply chain.
Generation of work flows, management control, calculation of profit margins and advanced statistical processing enable companies to monitor processes, optimize flows and achieve the highest levels of competitiveness.
Features of the Centro Software Solution
SAM ERP2 is a latest-generation ERP system that manages all business processes: PURCHASING, PRODUCTION, CRM, GOODS HANDLING and STORAGE, interaction with the SUPPLY AND SALES CHAIN, ADMINISTRATION, TREASURY, FINANCIAL management and management CONTROL.
Additional specific functions are included for the Medical Device industry, for optimal management of the processes of production, transformation, packaging and distribution, which allow validation of the processes concerned in compliance with EU GMP, Annex 11, US FDA - Code of Federal Regulations, Title 21, part 11 (21 CFR Part 11). From demand management (forecasts, goods orders, work orders) to product delivery, SAM ERP2 continuously generates production and purchasing plans (MRPII) and handles order management, quality control and materials flows.
The configuration of users and "roles" establishes permissions and responsibilities in accordance with the specific rules in use in the Medical Device industry.
The definition of product "status", validity period and complete traceability throughout the process of transformation and distribution ensure full operational and regulatory "consistency", while Audit Trail and electronic signature systems make it possible to unequivocally document every sensitive transaction for GMP validation, thus facilitating export and registration procedures, e.g. with the FDA.
WEB PORTALS and Sales Force Automation (SFA)
The full involvement of the sales force, scientific representatives and customers in business processes yields unexpected levels of efficiency and customer satisfaction.
The e-commerce web portal, which can be used for both B2C (Business to Consumer) and B2B (Business to Business) purposes, facilitates the process of opening up new markets and new business channels. Sales Force Automation (SFA) enables all mobile company operators equipped with a smartphone (sales and scientific representatives) to communicate in real time with the company's headquarters. Wherever you are, you can view the identifying data and accounting position of customers, enter new sales orders, and manage visiting rounds with your personal calendar.
DEMAND INPUT
SAM ERP2 ensures optimal synchronization between demand for and availability of products. Thanks to EDI tools and operational web portals, it is possible to collect orders and forecasts in a streamlined manner. Management of the "sales forecast plan" makes it possible to program procurement (purchasing or production of finished or semi-finished products) either separately from or jointly with the real order book, even in the absence of actual orders, and with a system that is also designed to manage "delivery programs" and "open orders".
"Closed cycle" MRP PROCESSING (MRPII)
This optimizes the allocation of work to the various company resources, with forecasting of product availability and delivery dates not only on the basis of order planning (MRP-I), but also on the basis of the actual production capacity of the company. The system therefore takes account of machines, plants, calendars, priorities and relationships between processing phases, production cells and departments or cost centers. For instant, comprehensive control, the system provides "dispatch lists" (work sequences for each production resource), analysis of "queues" and Gantt charts for each Production Order, which can also be modified graphically to change the scheduling, and to generate and save the different scheduling plans.
PRODUCTION ORDERS and MES
Full management of all phases of operational production, both in-house and on the sites of external vendors, including: production orders, picking slips and works sheets, advance checking of pickability (on the basis of batch characteristics, purity, tolerance, quality specifications, customer specifications or technical classifiers for manufacturers of devices and systems), work phase progress, management of testing and approval areas, time reading, management of processing by and for third parties, and instant checking and valuation of work completed, Work In Progress, commitments and the availability of materials. The MES system enables you to conduct real-time checks on the status and use of resources (machines, plants and personnel) by means of a synoptic panel, and read production times by means of bar codes, read personnel time and attendance in order to balance hours, use graphs to conduct instant checks on the output of each resource, and monitor the maintenance of plant and machinery.
QUALITY
The operating flows are natively integrated with the company quality system. ISO acceptable quality levels (AQLs), ISO and custom Sampling Methods, Sampling Plans by Vendor (with a choice of control severity levels depending on recorded performance), Approval and Non-Conformity Reports, etc. are handled in an integrated manner within the ERP system, involving all company departments, without any need for time-consuming, conventional procedures involving "Word" forms or departmental software.
WAREHOUSE MANAGEMENT and LOGISTICS (product "under analysis", "approved", "rejected")
On the basis of control plans, the system enables you to allocate the specific technical/administrative data for the production type concerned to each batch/serial number or loading unit (batch status, dates, certificates, etc.), which are essential for controlled, consistent goods handling. Thanks to integration with "advanced wireless logistics", goods can be identified and handled by reading the bar codes, which are validated in real time by the central system: entries, shipments, withdrawals, transfers, but also inventories, checks and sampling plans, management of storage locations (Aisles/Levels/Columns) and "loading units", as well as optimization of space, dynamic mapping of warehouses, etc.
ANALYTICAL and INDUSTRIAL ACCOUNTING, MANAGEMENT CONTROL
Detailed allocation of costs and revenues by destination, with 2 main objectives: work order accounting (which generates itemized statements by area, agent, article, etc., calculating profit margins) and cost center accounting, which collects the costs allocated to each department and calculates the costs per unit of work (gross hourly cost of personnel or plants). Accounting by business area (or division) also generates sector-specific statements by branch, production line, business division, break-even point, etc.
The Business Intelligence and DATAMINING systems automatically processes the necessary summary information for monitoring and directing the entire enterprise, with immediate generation of diagrams and graphs to facilitate their analysis and interpretation. The results of these processing operations play a vital role in ensuring that management takes the best operational and strategic decisions in the various areas.
