The fact that our company is regularly commissioned to build warehousing logistics systems from all major pharmaceutical companies in the country also contributes to the delivery of our systems in a fully validated state that fully meets industry requirements. Our pharmaceutical projects, and thus the validation of pharmaceutical computer systems, are implemented in accordance with the guiding requirements of cGAMP, 21 CFR Parts 210, 211 and Eudralex Vol 4 A.11. The development and validation of the systems is based on the full life cycle model and the so-called. Model V.
Our goal is to create documented evidence that can be used to establish with certainty that the Systems are operating consistently and reliably to predefined specifications. During the test procedures, Systems are examined at both horizontal (deployment-execution-execution) and vertical (user permissions, system events display, capture and retrieval) in order to objectively prove the validated state and its sustainability.
Testing of Systems can even be performed using simulations that are completely identical to the operating environment, so production processes are not affected.