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eve: The Solution for Validatable Computer-Aided Systems in GMP Processes
For validating its eve® bioprocess platform software, INFORS HT now offers validation packages that meet the requirements of FDA 21 CFR Part 11 and EudraLex Annex11
Good Manufacturing Practice, or GMP, is a system for ensuring production workflows – one that is mandatory in many areas of the life sciences, pharmacology and biotechnology. 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 & Drug Administration (FDA) have formulated corresponding specifications for computer systems and integrated these into their GMP 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.
Thanks to its User Management & Reporting feature, eve ® bioprocess platform software, offers a customized 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 validation package Basic 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.
The requirements of eve® functions with respect to those of FDA 21 CFR Part 11 and EudraLex Annex 11 are assessed in two white papers, which can be downloaded from www.infors-ht.com/eve.