Description
The eDOCSmanager Quality Module is a complete solution to comply with the requirements of quality management
in the life sciences industry.
Functionality of the eDOCSmanager Quality Module includes (but is not limited to):
l Maintenance of quality documents (e.g., SOPs) regarding the following:
l Classification of documents
l Life cycle management
l Periodic review
l Creation of documents from templates
l Controlled printing functionality
l Capture different types of quality events
l Processing complaints and deviations
l Plan and manage audits
l Documentation and processing of corrective and preventive actions (CAPAs)
l Managing change control processes
l Supplier Management
l Workflows with support for review, approval, and notification
l Learning management for:
l Digital training courses
l In person training courses
EXTEDOpulse automation features:
l Link to concerned products/applications within change control processes
(only available in combination with MPDmanager)
The eDOCSmanager Quality Module provides a complete, closed-loop process which is captured in an
expanding form: From tracking the initial issue to documentation of the preventative action to audit management.
Automated distributions/workflows are available for review, approval, and notification.
Additionally, you can create any type of Quality Documents. For example standard operating procedures
(SOP), policies, or manufacturing-related documents. eDOCSmanager provides built-in templates for such
documents to conveniently create a unified documentation. You can also add individual templates to the system.
You can manage your quality documentation through multiple life cycle states, from 'Draft' to 'Effective', and
'Obsolete'. The system drives all required review, confirmation, approval, and signature processes. This also
includes reminders for the periodic reviews of your documents and related training requirements.
(last updated Q1 2024, to version 24.02)
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