Support for Computerized System Validation (CSV)

 Growing Approach at BASSETTI

BASSETTI has progressively developed its offering for Computerized System Validation (CSV) support. Today, we provide our clients with tailor-made services aimed at ensuring optimal installation, flawless operation, and strict regulatory compliance, particularly in the pharmaceutical and medical device sectors.

What is CSV?

Computerized System Validation (CSV) is an essential regulatory requirement (cf. GMP Annexes 11 and 15). However, many clients face significant challenges: an often underdeveloped CSV culture (lack of training, absence of clear procedures), a lack of knowledge of applicable regulations (such as 21 CFR Part 11, ISO 17025, ISO 13485, etc.), and the complex management of version upgrades, a challenge that requires strict control of the risks associated with changes.

Who benefits from CSV?

In 2024, Bassetti supported several major clients, such as SAIPH, MESSER, PATHOQUEST, and many others, in their validation efforts. The recent testimony from SAIPH, which we will share soon, attests to the rigor and quality of our services, with a client fully satisfied with the support and coordination of activities provided by our teams.

CSV Approach in BASSETTI 

Today, Bassetti offers deep expertise and personalized support at every step of the project development process. Our experts guide clients to ensure solid and tailored compliance, while structuring and optimizing CSV with clear methodologies and practical tools. We thus ensure the validated state of the System (IS) is maintained, strengthening our clients' autonomy throughout the project.

Our CSV services go beyond simple compliance with standards; they transform the compliance of systems into a strategic asset that supports the client's business growth and resilience.

Our Methodology

Bassetti's methodology, coupled with the involvement of health sector experts, the use of robust tools (including the CHAPITEAU software), and our continuous support throughout the project, ensures comprehensive training that guarantees our clients' autonomy in managing and sustaining their IS compliance.

Current CSV Projects in 2025

For 2025, several new CSV projects are in preparation, with clients such as VIVACY, THEA, PILEJE, FAGRON, SOCOPLAN, and others. We will continue to deliver rigorous, compliant services focused on client satisfaction.

Thank you all for your commitment to this process and for the quality of service we offer to our clients.