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,
Companies are eager to implement cloud solutions, so they can cut costs and streamline their business efficiency.
Computer system validation is a procedure performed in every pharmaceutical or medical device company that uses IT systems at the stage of production, logistics or distribution of its products.
One of the increasingly popular forms of cloud computing are so-called SaaS services, or Software as a Service.
Validation is going through a paradigm shift. The new way of doing things is called Computer Software Assurance (CSA).