How eConsulting delivered efficient Computerized System Validation (CSV) results
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 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.
Our primary task was to assist the client in meeting deadlines for qualifying approximately 40 devices. The objective was SIP* Cycle Development (CD). The plan was to provide documented evidence that the SIP process could fulfill the defined acceptance criteria,
The client aimed to achieve the best GMP standard for spirits production in Europe. Their goal was to differentiate themselves from competitors based on quality assurance, ensuring that customers would choose their products even in the face of slight price differences.
Operating within the European market, our client must adhere to EU regulations while also preparing for inspections from international bodies such as the United States Food and Drug Administration (FDA). Their validation processes lacked comprehensive documentation.
The implementation and maintenance of the GMP system is a highly challenging, time-consuming, often tedious, and demanding task. It is so burdensome that most individuals working within this system would respond negatively to the question of whether to implement even elements of GMP if it is not directly required by law. The topic is very …
Implementation of GMP requirements in industries outside the pharmaceutical sector Read More »
The primary objective of this article is to provide an overview of the comprehensive topic of Factory Acceptance Tests (FAT) and Site Acceptance Tests (SAT). It begins by defining the core differences between the tests, moves on to the stages of test planning, defines the participants in FAT tests, etc.