As more and more research and production processes incorporate the use of electronic devices, computer-assisted systems and software, the European Medical Agency (EMA) and the US Food and Drug Administration (FDA) have formulated corresponding specifications for computer systems and integrated these into their GMP (Good Manufacturing Process) requirements.
These requirements cover technological, administrative and process-related issues, among others, and are spelled out in FDA 21 CFR Part 11 and EudraLex Annex.
Due to its User Management and Reporting feature, eve bioprocess platform software offers a customised package intended especially for computer-assisted processes subject to validation requirements.
With features such as predefined user roles, audit trails for all planned, ongoing and completed batches, and a comprehensive reporting system with export functionality, eve meets all of the technical requirements for successful validation, making it the ideal solution for legally compliant use within GMP processes.
In addition, INFORS HT also offers two versions of the documentation required for validation.
The Basic validation package includes standard documents such as declarations of conformity for the FDA and EMA. The validation package Plus is suitable for projects requiring more detailed documents such as a risk assessment and test protocols.
