Computerized Systems Validation

A documentation process that ensures the integrity of data related to automated industrial production, enabling complete traceability of information and proof of compliance with standards and requirements of the main regulators of the world (Guidelines to GMP Volume 5 - European Commission; EMA Annex 11; 21 CFR Part 11, etc.), as well as production optimization, reducing costs and increasing the quality of the final product.

Major Advantages of Validation

    • Ensures the integrity of production process information;
    • Helps improve the quality of final products;
    • Enables the usage of all automatic features available in the system;
    • Allows the technical team to retain in-depth knowledge of the validated systems;
    • Increases knowledge retention in case os staff attrition;
    • Optimizes computerized systems, enabling greater process automation and reliability;
    • Provides plan of action based on risk, thereby reducing production downtime and decreasing losses;

Click here and learn about Lifecycle Documentation and understand the process

Other services

Equipment and Utilities Qualification I.T. Infrastructure Qualification Data Integrity VLMS - Validation Lifecycle Management System