Success in the medical technology with ERP industry software

YAVEON ProBatch shows you the future 

  • Your daily work: identify and meet customer needs
  • Your challenges: strict regulations, process safety and reliability
  • Your solution: the ERP industry software YAVEON ProBatch
Elements of the medical technology industry as comic
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Regulations, Safety, and E-Health

The Medical Device Regulation (MDR) is just one example of the rise of regulations in the medical technology industry. With an ever-increasing elderly population, the need for medical devices is also growing, and at the same time, the interest in e-health products is increasing. Combined with progressive globalization and a noticeable market concentration, one thing is certain: The medical technology industry is changing.

Securing your future with ERP Industry Software

This naturally raises the question: How do companies meet all these daily challenges while successfully running their actual core business? The right software can help. That’s why the ERP industry solution YAVEON Probatch stands for simplification, reliability, and future-proofing.

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ERP industry solution YAVEON ProBatch 

You can expect these (and many more) advantages with the right industry functions

ERP Compliance Guidelines

Comply with regulations

Unique Device Identification, or UDI for short: Meeting the regulatory requirements is critical in the medical technology sector. It's easier with our ERP industry solution:

  • You can manage UDI information directly in the system
  • Integration into the logistic scanner processes
  • Optimized for cooperation with third-party manufacturers
  • Choose the most suitable implementation model

Your benefits: Better traceability increases transparency while the usage of scanners reduces your workload.

Audit Trail

Reliably track adjustments with change controls. In real-time and directly in the ERP system. No problem, with YAVEON ProBatch:

  • Compliance with relevant regulations
  • Free parameterization of critical data
  • Protective mechanisms at field level
  • Documentation of changes and the cause

Your benefits: Fulfillment of accountability requirements, and an increase in safety and data quality. Do you need to know who made specific changes at a specific time? You can find that out immediately and conclusively.

ERP Validation

ERP Validation

It’s more than a challenge to meet the requirements of GAMP 5; it is a fundamental obligation. The ERP solution YAVEON ProBatch is developed according to exactly these specifications:

  • Developed according to GAMP 5: Meets the specifications for the introduction of a validated ERP system
  • Product documentation as well as validation process templates
  • Change process and update scenarios are supported
  • Supported by experienced YAVEON consultants
  • Adaptation of the system to your validation specifications
  • Compliance with GMP requirements

Your benefits: reduced workload and increased safety. So you can look forward to computer system validation audits with confidence.

 

Quality control

Quality controls are part of your daily routine. You must meet the highest, and constantly changing, requirements. Our ERP industry software enables you to meet quality criteria at all times:

  • Adherence to Audit Trail, regulations, and compliance
  • Reliable and constant quality controls as well as testing accuracy specification per product
  • Avoid errors from the start thanks to quality constraints
  • Incoming goods inspection of your raw materials
  • Manage test plans and test equipment and create certificates of analysis
  • Automatically create inspection orders based on the process, and inspect semi-finished or finished goods
  • Monitoring of cleanrooms or equipment and management of stability tests

Your benefits: maximum safety with reduced workload and more transparency. You will be happy and so will your customers.

Warehouse and logistics management

A critical issue for manufacturing companies is efficient warehouse and logistics management. Use the appropriate features to keep an overview:

  • A comprehensive logistics solution - without interfaces to warehouse management systems
  • Separation of storage areas such as BTM or cold storage
  • Control station for your shipping processing and mapping of putaway strategies
  • Quarantine, restricted, and other batch statuses are taken into account
  • Extensive availability calculation regarding batch status and rules set
  • Stocks and batch data can be viewed in real-time
  • MDE solution for mapping relevant logistics and manufacturing processes
  • Management of load carriers & inventory processing
  • Mobile-ready

Your benefits: accelerated operations, reduced administrative workload, and maximal transparency - all in one solution.

Supplier evaluation

Are your suppliers an essential part of your supply chain? Do regulations such as ISO, FDA, or GMP require you to monitor and audit your suppliers? With excellent system support, you can easily meet these requirements:

  • Configurable supplier qualification with hard and soft criteria
  • Automated evaluation of schedule and quantity adherence
  • Capture of soft criteria for evaluation
  • Integration of risk monitoring
  • Quality qualification via the testing system based on the delivered products

Your benefits: This provides you with powerful arguments for supplier negotiations and enables you to develop the business relationship professionally. Build your supply chain sustainably, efficiently, and in compliance with regulations.

Elements of the pharmaceutical industry as comic

Research & Development

Customer wishes change - just like your products: You need to meet expectations while continuing to manufacture at a profit. The ERP industry solution from YAVEON simplifies this process:

  • Develop and manage recipes/bill of materials for new products
  • Version management of your recipes and parts lists
  • Selectively release recipes for manufacturing
  • Calculate costs of new products directly in the system
  • Consideration of all relevant product features
  • Preparation and shipment of samples

Your benefits: Manage research articles in an efficient and integrated way. Due to the centralized and comprehensive documentation, you can invest more time in the research and development of new products. You will be one step ahead of your competitors, and your customers will be delighted with your new ideas.

Batch management, serial number management, and traceability

You need to keep track of serial and lot numbers. This is essential in the medical technology industry - but it's not easy. This can be done better with ERP industry software:

  • Complete, detailed, multi-level lot and serial number traceability
  • Control which serial number and lot number were used at which time, under which conditions, and for which process
  • Management of lot status and features
  • Authorization control depending on lot status
  • Batch information can only be changed by authorized persons and in the permitted process step
  • Division and mixing of lots
  • The entire flow of goods is taken into account

Your benefits: Error reduction with increased safety and easier operation, especially in handling lots. This provides traceability along your entire supply chain.

EDI Data Exchange

Electronic data exchange

Day after day, you exchange various data with customers, suppliers, and other partners. Save time and prevent errors with digital processing:

  • Automated data exchange through the complete supply chain Order import, shipping notification, invoices in procurement and purchasing, through to the connection of external warehouses
  • Entirely digital document delivery
  • A complete package with all important components & data transfer, e.g., AS2, X400, OFTP & web services
  • Data conversion entirely without external converter, e.g., EDIFACT, AnsiX12, OpenTrans, IDOC
  • Create individual mappings without programming knowledge
  • Status control, tracking, error messages, and more - directly in Business Central
  • An integral part of your Microsoft Dynamics 365 Business Central and scalable system

Your benefits: A standardized and fast connection of any EDI partner. Extensive configuration features eliminate the need for customized programming. Have more time for essential tasks by reducing errors and increasing automation.

Mobile scanner integration

Fast and as error-free as possible - this is how the delivery to your customers must proceed. This is exactly where the scanner solution helps:

  • Integrated solution for mobile scanners
  • Support of all relevant warehouse processes, including load carriers and packaging materials
  • Warehouse-friendly with greatly simplified dialog guidance, particularly geared to working with barcodes
  • Lowest hardware requirements: no additional app, no installation on the scanner - you just need a browser 
  • Processing operations are executed directly in the ERP system. Real-time information instead of time lags and additional interfaces

Your benefits: You increase your performance in the warehouse across the board and significantly reduce the error rate.

ERP Mobile Scanning Function

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Our ERP Customers in the medical technology industry

MICROSOFT ERP MEETS INDUSTRY SOLUTION

ARE YOU LOOKING FOR MORE IN-DEPTH INFORMATION ON OUR ERP SYSTEM? YOU HAVE COME TO THE RIGHT PLACE.

In the whitepaper of our industry solution YAVEON ProBatch, you will learn

  • everything about the foundation, Microsoft Dynamics 365 Business Central,
  • why an industry solution makes sense,
  • which features make YAVEON ProBatch unique,
  • how a ProBatch project proceeds,
  • how an ERP project can be realized without interfering with day-to-day operations,
  • what the four most important goals of an ERP project are,
  • and much more.
Vorschau Whitepaper ERP-System YAVEON ProBatch

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