Our EDM quality application complies with 21 CFR Part 11 (FDA)
GxpManager’s EDM Quality (Electronic Document Management) application simplifies the management of documents flows in highly regulated environments. You benefit from a range of compliant features (traceability, electronic signature, versioning, user rights management…) to optimize the validation and distribution cycle of your documentation.
- You accelerate and you secure the creation of your quality documents, SOPs, Work Instructions…
- You centralize and considerably simplify the research and access of documents thanks to the filtering system & a personalized interface for every user.
- You simplify the distribution to the concerned addressees and you strengthen the tracking of your documentation reading and approval thanks to the automatic reminders and alerts.
- You save time and money, you reinforce processes tracking and you make sure you have a constant up to date information.
FDA 21 CFR part 11
Workflow
Monitoring levels of approval for data or test implementation made easier.
Audit Trail
Tracking changes to ensure integrity and coherence of data that is subject to standard rules and regulations.
Versioning
Automated versionning guarantees information stability in a sustainable manner by keeping a history of former versions.
Electronic Signature
Guarantees registration integrity, author identification and forbids any change to the signed element.
Email Notifications
Share information by using your electronic mail (Microsoft Outlook© or other) with email attachments.
GxpQMS
The Webinar presents the GxpQMS (Quality Management System for Small and Medium Enterprises) application which can be implemented in a few days as compliant and auditable quality system.
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