Computerised systems validation

Control and secure your industrial data

In a production unit, computerised systems play an essential role in ensuring automation, management and data traceability. Their validation is a key step in ensuring their proper functioning, regulatory compliance and data integrity.

At Projipharm, we support our clients in implementing a robust validation process, ensuring that each system performs its functions in a reproducible, reliable and compliant manner.

A STRUCTURED AND COMPREHENSIVE VALIDATION PROCESS

Our experts are involved at every stage of the computerised systems lifecycle, integrating data integrity requirements from the design stage onwards:

✔ Definition of the Validation Plan,
✔ Collection and analysis of user requirements,
✔ Risk assessment and compliance,
✔ Qualification (QI, QO, QP),
✔ Document management and monitoring of regulatory requirements.

We ensure that your systems comply with best practices (GAMP 5, 21 CFR Part 11, GMP
Annexes, BPF, etc.), thereby guaranteeing the integrity and security of your data.

OUR COMPUTERISED SYSTEM VALIDATION SERVICES

✔ System deployment and development

Deployment of new software
Management of IT system upgrades
Modification and updating of IT infrastructure
Development of monitoring systems

✔ Compliance and audits

Implementation of regulatory changes,|
Periodic review of IT systems,
Preparation for customer audits and regulatory inspections.

✔ VSI project management

Thanks to our expertise in Service Management, we take care of the overall management of your VSI projects and train your teams to ensure that the required level of data integrity is maintained.

📢 Need help with computerised system validation? Projipharm supports you in ensuring the compliance, reliability and integrity of your systems!

Our Activities

Whether on a contract or fixed-price basis, Projipharm provides services to industrial companies. Our offering enables us to support our clients throughout the design and implementation phases.

Our expertise covers all areas of industrial production, processes, equipment and infrastructure.