Why bother amending SOPs (Standard Operating Procedure) at all when things have been fine so far? We worked so hard two years ago during the last amendment, and we already have so much other work, so why stir things up now? On the one hand, it’s just three things that need changing, maybe five sentences …
The client sought to validate two modules within a new system, P4Labs, developed to meet specific company requirements (GAMP 5 category). The modules included:
The client’s objective was to re-validate their clinical testing management system, comprising multiple modules. Following an audit deviation and the outcome of the periodic review, the client aimed to attain a verified state of the system, aligning with legal requirements and best practices.
We provide comprehensive and goal-oriented quality services for companies in regulated industries and beyond. We handle everything from step one and deliver more than you expect. On time.
Contact
Main office:
Aleje Jerozolimskie 195B
02-222 Warszawa
Wrocław office:
ul. Piłsudskiego 13
50-048 Wrocław
ecvalidation is a team of experts specializing in validation and qualification services of software, equipment, installations, rooms and processes.