A platform with ready-to-use eQMS applications
A Quality Management System (QMS) that combines the necessary applications for quality procedure management: handling Non-Conformance (NC) and complaints with Corrective and Preventive Action plans (CAPA), Change Control (CC), Quality Document Management, and training follow-up.
Have a complete, adaptable and 100% customizable regulatory quality management system
Affordable solution that complies with international regulations, such as FDA 21 CFR Part 11 and GMP in Europe.
- Design and Manufacturing
- Technical documentation : Ensure that you choose the right compliant document
- Risk management : Implement a risk-based strategy in line with your business requirements
- Quality Management : Have a powerful and an easily adaptable QMS for your organization : Workflows, reviews, distribution, electronic signatures, traceability
- Manage your Quality Actions
- Quality event management
- Document your Regulatory Vigilance
- Internal and external Audits Management (Add On cost)
The benefits of a Quality Management System
- Maintain high-quality standards and compliance in your industry.
- Bring your organization together with collaborative quality culture.
- Get your audits done easily & successfully.
With GxpManager’s QMS-4-SME, pass your audits and obtain your quality certifications. This Quality Management System allows you to manage the quality of your organization, but also to define your objectives, as well as to implement a quality policy that complies with the regulations in place.
The solution natively integrates several functionalities, such as the audit trail, the workflows with electronic signature, and versioning.
FDA 21 CFR part 11
Audit Trail
Tracking changes to ensure integrity and consistency of data that is subject to standard rules and regulations.
Electronic Signature
Guarantees registration integrity, author identification and forbid any change to the signed element.S
Workflow
Monitoring levels of approval for data or test implementation made easier.
Versioning
Automated versionning guarantees information stability in a sustainable manner by keeping a history of former versions.
Access Management
You can create a profile for each user or group of users according to their access rights for features, databases, reading, writing, deleting or implementation.
Attachments
It is possible to create links to outside files or incorporate attachments (image, document…) directly as recordings.
Calculation Fields
You can build or insert complex calculation formulas (duration, standard deviation, averages, progress, any value from other fields…).
360° View
Allow to obtain an immediate visualization of the chain of links associated with a record (links in all directions).
Email Notifications
Share information by using your electronic mail (Microsoft Outlook© or other) with email attachments.
Statistics
You can create and view numerous types of graphic reprezentations for analysing your data in real time, including calculation formulas
Traceability Matrices
You can define matrix for traceability (simple or star shaped) with a data overall vision (specifications, tests, regulations… coverage).
Automatic Publishing of Reports
Create, automatically publish and record personalized reports.
Import and Export In One Click
Import data (and the links between data). Export your data in MS Excel®, MS Word® or MS Project®.
Quality management system, a performance driver
The quality management system represents a challenge for companies. When it is digitalized, it becomes an undeniable performance driver.
Learn moreQMS-4-SME
The Webinar presents the QMS-4-SME (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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