Who is CSV relevant for?
CSV is important for companies operating in sectors such as:
- Manufacturing and supply of pharmaceutical products;
- Manufacturing and supply of medical devices used in or on patients;
- Manufacture and supply of food products that may have a medical application, such as, but not limited to, baby food.
If your organization operates in one of these sectors, CSV helps ensure systems are compliant, manage risks, and organize processes in a structured and efficient manner.
Implementation of automated systems
When implementing or modifying automated systems, Yxion consultants ensure that everything is set up correctly from the start. We assess the impact on processes and regulations within your industry to ensure that systems meet the relevant quality requirements. Thanks to our extensive experience in the life sciences, we know exactly where the risks lie and how to keep them under control.
Examples of systems we support
To ensure reliable and accurate data, systems must be properly validated. Our experts know exactly when validation is needed and how to perform it efficiently. We advise, guide, and perform validations in accordance with the guidelines of Good Automated Manufacturing Practices (GAMP). In addition, we verify that systems comply with FDA Regulation 21 CFR Part 11.
Examples of systems we support include:
- Laboratory Information Management Systems (LIMS) in QC environments;
- Manufacturing Execution Systems (MES) used in the production of pharmaceutical products or medical devices;
- Enterprise Resource Planning (ERP) systems used in pharmaceutical environments for managing materials and batch records;
- Document management systems used in QA environments. With such systems, data integrity is often a key focus during validation;
- Production and process automation systems, such as PLC and SCADA systems.
Your partner in quality, safety, and compliance
The life sciences sector requires specialized knowledge and reliable guidance. Thanks to our extensive expertise, we help organizations comply with laws and regulations, ensure quality, and continue to innovate with confidence.
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