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 help customers to meet the requirements of FDA 21 CFR Part 11 and EudraLex Annex11

Bottmingen, (PresseBox) - 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 eve® functions with respect to the requirements 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.

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INFORS HT

INFORS HT is your specialist for bioreactors, shaker incubators and bioprocess software. You benefit from sophisticated systems that contribute to your success by maximizing the productivity of your cell lines or microorganisms without sacrificing reproducibility.

We offer the right solutions for your applications:
- Fermentation of microorganisms (bacteria, fungi and yeasts)
- Cell culture (mammalian cells, insect cells, plant cells and algae)
- Biofuels (biodiesel and bioethanol)
- Bioprocess integration in one software platform
- Customer-specific bioreactors and incubation shakers
- Qualification of bioreactors and incubation shakers

An eye toward solutions and personal, sustainable customer relationships are our greatest strengths.

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