ADVANCING BIOTECHNOLOGY WITH THE RIGHT ERP INDUSTRY SOLUTION

YAVEON PROBATCH CAN MAKE YOUR JOB EASIER

  • Your daily work: unpredictable development processes, intense pressure to innovate
  • Your challenges: project financing and licensing
  • Your solution: the ERP industry software YAVEON ProBatch
elements of the biotechnology industry as comic
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MANUFACTURING, REGULATIONS, AND DIGITALIZATION

Your journey takes you from research to reliable, compliant, and future-proof production processes, and onward to satisfied customers. You must meet the stringent requirements in the regulated environment, push your business forward, secure funding, and obtain licensing for your preclinical leads. All while you cope with the pressures of digitalization. A potent mixture of challenges.

MASTER YOUR CHALLENGES WITH ERP SOFTWARE

The right solution facilitates all necessary operations and even enables automation. Take a look at the unbeatable combination of the ERP system Microsoft Dynamics 365 Business Central and the ERP industry solution YAVEON ProBatch.

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ERP Industry Solution YAVEON ProBatch 

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

Elements of the pharmaceutical industry as comic

Research & Development

Do you need help to cope with the pressure to innovate while continuing to manufacture at a profit? The R&D functions of our ERP industry solution accomplish just that:

  • Development and management of your recipes/bill of materials for innovative 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
  • Selectively release recipes for manufacturing
  • Preparation and shipment of samples

Your benefits: efficient and integrated handling of research articles. Due to the centralized and comprehensive documentation, you can invest more time in the research and development of new products. This will please your customers and keep you one step ahead of the competition.

Quality control

Whether business or consumer: In biotechnology, quality comes first. To ensure this, you are bound by an increasing number of regulations and must comply with strict quality controls. Your ERP industry solution can facilitate the process:

  • Adherence to Audit Trail, regulations and compliance
  • Quality controls as well as error prevention thanks to quality constraints
  • Incoming goods inspection of your raw materials
  • Manage test plans and test equipment and create process-related inspection orders
  • Inspect semi-finished or finished goods and monitor clean rooms or equipment
  • Manage stability tests and create certificates of analysis
  • Specification of the test severity per product

Your benefit: maximum safety with reduced workload and more transparency. Peace of mind for you and your customers.

EDI Data Exchange

Data exchange, for example, with retail chains

Data exchange is fundamental for functioning business processes and lasting success. Facilitate this by connecting automated electronic data exchange directly to your ERP system.

  • Automated data exchange of the supply chain - from purchasing via warehouses and contract manufacturers through to sales
  • 100% digital document delivery
  • Configurable data conversion without external converter
  • With all components relevant for EDI, including data transfer, such as AS2, X400, OFTP and web services
  • Status control, tracking, error messages, and other capabilities in your Microsoft Dynamics 365 Business Central
  • An integral part of your ERP system and easily scalable

Your benefits: A standardized and fast connection of any EDI partner. Configurable features eliminate the need for customization programming, leading to decreased error rates and increased automation. Saving you time that you can use for essential tasks.

Supplier Management

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 - enabling you to build your entire supply chain sustainably, efficiently and in compliance with regulations.

Batch analyses and batch management

Batch traceability is one of the most important, and at the same time, most challenging requirements for the biotechnology industry. Our ERP industry software helps:

  • Complete, detailed, and multi-level lot traceability
  • Control which serial number and lot number was used at which time, under which conditions, and for which process
  • Lot and serial number tracking and management of batch status and features
  • Authorization control depending on lot status
  • Changes to batch information only possible for authorized persons and in the approved 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.

Comply with regulations

Directives, regulations, specifications, GMP, ISO, EU Cosmetics Regulation, FD&C Act, or CFR Title 4 & 11 - compliance always keeps you busy. Our ERP industry solution facilitates the processes:

  • Integrated batch tracing
  • Data fields define who is authorized to make which change
  • Electronic signatures (dual control principle)
  • Audit Trail
  • Data integrity

Your benefits:  Regulations concerning the handling of your lots can be mapped more efficiently, which reduces errors. You are prepared for any eventuality, compliant, and able to provide complete information. To summarize: You don’t have to worry about upcoming audits.

ERP Compliance Guidelines
ERP Validation

ERP Validation

The regulatory requirements for successful computer system validation are stringent. YAVEON already takes these specifications into account during product development and uses a tailored, proven project methodology:

  • Developed according to the specifications of GAMP 5 and meets the requirements for the implementation of a validated ERP system
  • Product documentation and templates for validation processes
  • Change process and update scenarios are supported
  • Supported by experienced YAVEON consultants
  • System adaptable to your validation specifications requirements.
  • Compliance with GMP requirements

Your benefit: reduced workload and increased safety. You aren’t fazed by computer system validation.

Audit Trail for documentation of changes in the system

Change controls - important in many industries, essential for biotechnology. Track changes directly in the system with our ERP industry solution - in real-time:

  • Compliance with relevant regulations
  • Critical data can be freely parameterized
  • 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.

Logistics

Do you need to keep an overview of current article availability? And do you need a control system to keep an eye on your logistics at all times? Is this possible?

  • A comprehensive logistics solution - without interfaces to warehouse management systems
  • Separation of storage areas such as cold storage and a control station for dispatch processing
  • Mapping of complex storage strategies, and availability of stocks and batch data in real-time
  • Quarantine, restricted, and other batch statuses are taken into account
  • Extensive availability calculation regarding batch status and rules set
  • MDE solution for mapping relevant logistics and production processes
  • Management of load carriers and inventory processing
  • Mobile-ready

Your benefits: Accelerated processing, reduced administrative workload, and full transparency - all in one holistic system.

The best argument: satisfied customers.

"Of course we looked at other solutions. However, YAVEON ProBatch for the biotechnology industry was clearly more specific than the other systems. Moreover, the YAVEON board of directors was genuinely interested in us and we felt that we were taken very seriously."

Klemens Wressnig, TriOptoTec GmbH

Reference logo Trioptotec

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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