ERP & CRM for Biotechnology Companies
Sycor – Your Strategic Partner for Regulated ERP Transformation
Sycor supports biotechnology companies in the implementation and further development of ERP and CRM systems in highly regulated environments. With a deep understanding of regulatory requirements, validatable system architectures, and comprehensive end-to-end services, we ensure your organization is technologically and regulatory future-proof.
Your Challenge: Innovation Under Regulatory Pressure
Biotechnology companies operate in a highly regulated yet innovation-driven environment. Research, development, production, and marketing must work together efficiently—without compromising on compliance, data integrity, or audit readiness.
Stringent regulatory requirements (GxP, FDA 21 CFR Part 11, EU GMP, ISO, and, where applicable, MDR/IVDR)
Data scattered across ERP, LIMS, PLM, CRM, Excel, and legacy systems
Increasing audit and documentation requirements
International approvals with clear deadlines and documentation requirements
Scaling from the research laboratory to commercial production
Digital Transformation in Biotechnology: Implemented the Right Way
A successful ERP and CRM implementation in biotechnology does not start with the software, but with processes, data, and an understanding of regulatory requirements. The goal is a seamless, traceable, and audit-ready system landscape.
We support biotechnology companies in:
- Mapping research, production, and quality processes end-to-end
- Systematically embedding regulatory requirements
- Ensuring long-term audit readiness
- Providing data in a centralized, versioned, and analyzable format
Our Approach: End-to-End. Regulatory. Future-Proof.
Sycor combines ERP, CRM, and BI solutions with in-depth industry and compliance expertise. We support our clients from strategy through implementation to stable operations.
- Design and implementation of validatable ERP and CRM landscapes
- Systematic mapping of regulatory requirements (GxP, FDA, ISO, MDR/IVDR where applicable)
- Support for validation, audit readiness, and compliance processes
- Optimization of production, finance, sales, supply chain, and logistics processes
A Partnership That Takes Responsibility
We do not see ourselves merely as an implementation partner, but as a strategic advisor. Our commitment is to take responsibility for regulatory compliance, process quality, and sustainable business success.
Everything related to your project
Through numerous IT projects, we have built up an invaluable wealth of experience. We know exactly what it takes to ensure an IT project is successful. You, too, can benefit from our expertise!
Suitable systems include those that are validatable, auditable, and internationally scalable, such as Microsoft Dynamics 365 or SAP S/4HANA. A key requirement is a regulatory-compliant implementation and a robust validation strategy.
ERP validation is the documented evidence that an ERP system is suitable for its intended use and consistently meets regulatory requirements. The goal is audit readiness, data integrity, and compliance.
Yes. A properly designed and validated ERP system supports FDA and MDR audits through centralized data management, complete traceability, and audit-ready processes. Auditors can review relevant documentation more quickly, risks are reduced, and the effort required for audit preparation is significantly reduced.
Both cloud-based and on-premises ERP solutions are suitable for biotech companies, provided they have been properly validated in accordance with regulatory requirements. The decision depends on compliance requirements, security needs, and IT strategy. Regardless of the operating model, it is essential to have a well-defined validation plan, clear lines of responsibility, and documented governance structures.
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