INFORS HT is adding new features to its eve® bioprocess platform software. The User Management & Reporting package is oriented toward users needing to perform sophisticated validation processes that meet FDA Part 11 specifications. The package also includes a comprehensive reporting system for a complete documentation.
User Management & Reporting is the second software package that can be combined with the core version of eve®, a platform software launched in September 2016. Thanks to this new package, eve® now meets all of the specifications for FDA CFR 21 Part 11—the global standard for secure electronic processes in the industry.
“The package offers 5 predefined user roles, each with different rights. Computer-based access control, an audit trail, highly secure passwords and read-only guest access for audits are a few examples of how we ensure process security with this web-based platform software,” explains Franco Berz, head of Quality Management at Infors AG. “User Management and Reporting is the perfect tool for users requiring FDA validation.”
The package also offers extensive options for tracking and documenting planned, current and completed experiments. Detailed reports can be exported as a PDF for documentation purposes or imported directly into PowerPoint, Word or Excel as a working document, allowing users to generate finished presentations at the press of a button.
Thanks to its modular structure, eve® gives users the flexibility to expand the core software and meet their customer requirements by adding the “User Management & Reporting” and “Plan & Control” packages. Users can create their own bioprocess platform from which they can plan, control, watch, evaluate and document their bioprocesses. eve® will be continuously expanded with additional features and packages.
User Management & Reporting is the second software package that can be combined with the core version of eve®, a platform software launched in September 2016. Thanks to this new package, eve® now meets all of the specifications for FDA CFR 21 Part 11—the global standard for secure electronic processes in the industry.
“The package offers 5 predefined user roles, each with different rights. Computer-based access control, an audit trail, highly secure passwords and read-only guest access for audits are a few examples of how we ensure process security with this web-based platform software,” explains Franco Berz, head of Quality Management at Infors AG. “User Management and Reporting is the perfect tool for users requiring FDA validation.”
The package also offers extensive options for tracking and documenting planned, current and completed experiments. Detailed reports can be exported as a PDF for documentation purposes or imported directly into PowerPoint, Word or Excel as a working document, allowing users to generate finished presentations at the press of a button.
Thanks to its modular structure, eve® gives users the flexibility to expand the core software and meet their customer requirements by adding the “User Management & Reporting” and “Plan & Control” packages. Users can create their own bioprocess platform from which they can plan, control, watch, evaluate and document their bioprocesses. eve® will be continuously expanded with additional features and packages.
