Ennov’s Quality suite is a quality management solution that not only improves operational efficiency but also ensures compliance with industry standards such as 21 CFR Part 11, GxP and ISO. Ennov Quality provides a predefined inventory of quality documentation, processes and workflows that are based on accepted industry standards and best demonstrated practices. This allows Ennov Quality customers to get their system into production quickly and start realizing their return on investment. Ennov Quality, like all Ennov solutions is very easy to configure and requires no IT skills.
Maintaining a paper-based, ISO-compliant document system is cumbersome, time-consuming and error-prone. Increase your productivity by automating the repetitive tasks associated with quality document management. Managers maintain clear visibility into the document lifecycle and can proactively monitor workflow status to improve the quality system efficiency.
Geographically dispersed teams can collaborate to co-author, proofread, comment and sign documents electronically within the system. Automatic email notifications and read receipts expedite document distribution throughout the organization. Controlled printing, periodic reviews, automated document retention and archival schedules and full compliance with US FDA’s 21 CFR part 11 take the worry out of audits and quality inspections.
Unreliable information, fragmented processes and inadequate monitoring can jeopardize your organization’s quality certification. Ennov Process offers a complete solution for managing all of your quality processes. Without automation, the systematic recording, routing, and tracking of quality forms and related information can be overwhelming. Ennov Process allows you can streamline the processes critical to managing quality cases (e.g. CAPAs, deviations, non-conformances and customer complaints). A complete suite of to-do lists, smart email notifications, and reminders help you stay ahead of deadlines, increase productivity and take control of your quality program.
Making sure your employees receive the appropriate training on internal policies and procedures is key to both individual and corporate performance. Ennov Training gives you confidence that all employees have obtained the requisite skills and knowledge required to effectively perform their work in compliance with corporate and industry quality standards.
Ennov Training is designed with both Training Administrators and Trainees in mind and streamlines the entire learning management process. Automated reports provide the visibility required to verify that each employee has been properly trained – greatly simplifying audits and quality inspections.
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