The ERP for biotechnology

Yaveon 365 is the ERP for biotechnology, built on Microsoft Dynamics 365 Business Central. It supports regulated processes from research to finished product and ensures compliance and end-to-end traceability through to shipment.

Efficient development: turn ideas into products reliably

Top quality: maintain standards with quality control

Full security: ensure traceability and compliance

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ERP System of the Year Jury‑selected

ISO 9001 DEKRA‑certified

Top ERP Provider Process manufacturing specialist

More than 1,000 customers worldwide rely on Yaveon

What benefits does Yaveon 365 offer biotechnology companies?

Yaveon 365 brings demanding biotech processes together and simplifies them. The ERP provides transparency, reliable audits, and compliance along the supply chain, all in one central solution without system breaks.

Meet legal requirements reliably

Map regulatory requirements in an audit-ready way. Capabilities such as audit trails, electronic signatures, and role-based permissions support data integrity and processes in line with GMP, GAMP 5, EU GMP Annex 11, and 21 CFR Part 11.

Faster product development

Accelerate your development cycles with structured R&D processes, clear formula versions, and a fully documented transition from lab to production. This reduces coordination effort and frees up time for new innovations.

Complete traceability

Create certainty and trust internally, with partners, and with authorities through complete batch transparency. Trace every step precisely from raw material to finished product and noticeably speed up your audits and recall processes.

Quality and safe products

Automate your quality assurance: with clear inspection processes, documented methods, and certificates of analysis, you create reliable, traceable, and always audit-ready processes for maximum product safety.

How does Yaveon support validation and data integrity in biotechnology?

Yaveon supports validation and data integrity in biotechnology with an end-to-end approach. From validation concepts, testing, and documentation to the assessment of changes and updates, we enable (cloud) validation in regulated environments for robust audit evidence and reliable data.

Which biotechnology companies is Yaveon 365 suitable for?

Yaveon 365 is designed for mid-sized biotechnology companies with their own production. This also applies to companies moving from research and development through lab and pilot phases into production.

Research and development

Biopharmaceutical production

Blood plasma products

Vaccines

Agricultural biotechnology

Typical processes

Formula- and batch-oriented production processes, such as fermentation, extraction, mixing, and filling, as well as GMP-regulated processes that require validation

Typical requirements

Strict requirements for quality, compliance, documentation, and auditability, for example from GMP or GLP

What Yaveon 365 covers

Complete lot tracking, data integrity, and documented inspection and approval processes, plus management of formulas, specifications, and quality-relevant data

How does Yaveon support international rollouts in the biotechnology industry?

Yaveon supports international ERP rollouts in the biotechnology industry with a structured implementation that reliably combines global standards and local regulatory requirements. Thanks to our global partner network, central standards merge with local market knowledge into consistent, secure processes worldwide.

Which ERP features does Yaveon 365 cover in biotechnology?

Yaveon 365 brings together the key ERP features for biotechnology, including batch management, production, research, quality control, and compliance.

How does Yaveon 365 help you stay compliant?

Meet regulatory requirements reliably and traceably, including audit trails and electronic signatures.

Support for GMP, GAMP 5, and EU GMP Annex 11 requirements
Electronic signatures and records compliant with FDA 21 CFR Part 11
Configurable tracking of relevant database changes with audit trail
User-dependent field security for critical data fields
Documentation of data changes with reason for change
Integrated label reconciliation
Status management with configurable approval workflows for batches and relevant production and quality plans

How does Yaveon 365 ensure transparent lot tracking?

Full transparency into ingredients and manufacturing processes builds trust, minimizes risk, and meets legal requirements. If something goes wrong, you identify affected batches quickly and precisely, manage recalls in a controlled way, and reduce the effort for tracing and communication.

Lot tracking across all process stages
Rule management for optimized, regulated inventory management
Full integration with QA, production, and logistics
Recording and tracking incidents along the supply chain

How does Yaveon 365 support production?

Process manufacturing from end to end: formula variants and formula-based production with integrated support for filling and refilling processes. This creates consistent transparency and stable operations across the entire production cycle.

Formula-based manufacturing and management of manufacturing instructions
Integrated active ingredient management
Production planning based on FIFO and FEFO
Integrated quality control, including in-process control
Real-time production data collection, also by scanner
Setup time optimization through planning based on batch features
Four-eyes principle for production approvals
Batch inheritance in production

How does Yaveon 365 ensure consistently high quality?

Ensure consistent quality: integrated inspection processes document everything transparently and audit-ready.

Integrated inspection plan and inspection order management
Fully automated creation of quality inspections
Flexible blocking and approval workflows for your products
Certificate of analysis (CoA) and specification management
Sample management
Integrated dashboard for quality analysis of purchased and manufactured products
Capture of measured values on mobile devices
Stability tests and retention sample management
Product quality review (PQR) based on batch and inspection data

How does Yaveon 365 enable GMP-compliant warehouse management?

Manage warehouse processes reliably and in a GMP-compliant way, from warehouse receiving to shipment.

Complex put-away strategies, such as separate storage areas for hazardous substances and cold storage
Quarantine, blocked, and other batch statuses
Manage inventory lists
Optimize outbound processes and order picking logic
Availability calculation based on batch status and rule set

How does Yaveon 365 support warehouse and production processes in real time?

Precision is what counts in process manufacturing. Barcode-based scanning processes, postings guided by batch and status, and guided dialogs prevent errors, safeguard quality, and still increase speed.

Data capture with GS1 and DataMatrix barcodes
Controlled scanning processes for logistics, production, quality, and shipping
Real-time data capture for your ERP
Complete mobile data capture from warehouse receiving to shipping, also offline

How does Yaveon 365 help you achieve consistently high supplier performance?

To secure your supply of raw materials and the stable quality of your products, you evaluate and classify your suppliers transparently with Yaveon 365.

Supplier evaluation with freely definable KPIs
Classification by quality
Analysis of deadline reliability and quantity reliability
Freely definable soft evaluation criteria

How does Yaveon 365 create more transparency into quality, costs, and processes?

With standardized dashboards and reports, you analyze batch, quality, and process data in a structured way and detect deviations early.

Standardized Power BI cockpits for relevant KPIs
Real-time analysis of batch, quality, and lead time data
Management reports on margins, costs, scrap, and inventory
Early detection of deviations and bottlenecks

How does Yaveon 365 help you bring innovations to market safely and purposefully?

With clear versions, transparent approvals, and reliable cost calculations, you structure the path from development to operations. Changes stay traceable, specifications remain consistent, and handovers to operational processes are easy to control.

Formula versions and change tracking
Approval workflows for formulas and specifications
Cost calculation for new products and variants
Transparency into substances and specifications used
Clean handovers between development, approval, and production

How does Yaveon 365 help you handle complaints?

Process complaints efficiently, analyze root causes precisely, and strengthen your customers' trust over the long term.

Structured recording of incidents
Management of tasks to improve affected processes
Easy links to relevant ERP transactions such as credit memos and complaints
Consistent quality and continuous improvement process instead of one-off actions

How does Yaveon 365 enable electronic data interchange?

Complex data flows made manageable: purchase orders, delivery notes, and invoices are exchanged, validated, and processed automatically. This creates transparent, fast processes without system breaks along the entire supply chain.

Connect trading partners directly to your ERP
Conversion directly in the system without external tools
Import and export of ORDERS, INVOICE, DESADV, and more
Send via common communication channels such as AS2, X.400, OFTP, HTTP, and more

Mockup whitepaper Yaveon 365 for the biotechnology industry

Yaveon 365: the whitepaper for biotechnology

What else can our industry-specific ERP solution do for you? How does it make your work easier while keeping processes secure? Our whitepaper gives you all the key information for success in biotechnology.

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We multiplied our revenue several times over in two years, and the ERP system has grown with us.

– Kevin Urbaum, Director Tech & Data at Sanity Group

To the success story

From the very first moment, it was clear that the consultants at Yaveon know validation inside and out. Communication was excellent right from the start.

– Petra Duchrau, Head of IT at Sirio Pharma Germany

To the success story

When it comes to ERP implementation, consulting, and support, only praise. There was nothing at all to complain about.

– Andreas Schonert, Chief Sales Officer at CTL Europe GmbH

To the success story

Just as with the NAV project a few years ago, collaboration with Yaveon during the implementation of the EDI interface was also based on trust.

– Dr. Stefan Bartsch, Director Sales Western Europe at hameln pharma GmbH

To the success story

Frequently asked questions about the biotech ERP solution

Why do biotechnology companies need a specialized ERP system?

Biotechnology companies need a specialized ERP system because research, development, production, quality management, and regulatory requirements often do not come together consistently in a standard ERP. When data, approvals, and evidence are separated between lab, pilot phase, production, and supply chain, coordination effort, system breaks, and audit risks increase. Yaveon 365 provides a central, industry-specific foundation for controlled processes, reliable data, and sound decisions in the regulated biotech environment.

Does Yaveon 365 support requirements from EU GMP Annex 11 and 21 CFR Part 11?

Yaveon 365 helps biotechnology companies implement requirements from regulated environments in a structured way. These include audit trails, electronic signatures, role-based permissions, protected data fields, and traceable change documentation. This lays the foundation for audit-ready processes and secure documentation.

How does Yaveon 365 support data integrity according to ALCOA+?

Yaveon 365 ensures data integrity through clear permission structures, complete change logs, and documented approvals, so all data changes remain transparent and traceable at all times. Biotechnology companies also benefit from information that can be clearly attributed in every process step, remains legible at all times, is documented promptly, and is complete and consistent.

How does validation work in cloud environments and with updates?

Validation remains a central topic in cloud environments and dynamic IT landscapes as well. Yaveon 365 supports you with a structured documentation basis, clear change control processes, and proven templates for risk-based validation activities. You assess changes in a controlled way, document them, and integrate them into existing quality processes.

Can Yaveon 365 be connected to LIMS, QMS, MES, or ELN?

Yes. Yaveon 365 integrates into existing system landscapes and supports structured data exchange with systems such as LIMS, QMS, MES, ELN, DMS, or EDI solutions. This reduces isolated solutions, avoids duplicate data maintenance, and creates reliable, end-to-end processes.

How does the implementation of Yaveon 365 work in regulated biotechnology environments?

Yaveon 365 is implemented in biotechnology companies in a structured way that is aligned with regulated, batch-based, and documentation-intensive processes. Our proven project methodology, Yaveon ProCedures, carries out the implementation systematically and lays the foundation for traceable processes and a secure system rollout.

What costs should you expect for implementing and operating an ERP system for biotechnology?

The exact costs of implementing an ERP system in the biotechnology industry depend on your company size, the project scope, and the features and integrations you need. They usually consist of one-time costs for setup and migration plus ongoing fees for licenses, training, and support. We create a reliable cost estimate tailored to your individual processes and priorities.