Ensured compliance with GxP, SOx, ISO, ICH, GAMP…
- The GxpManager ALM/PLM application allows you to manage all necessary required life cycle stages in the project, product or system while keeping the highest quality and compliance requirements.
- ALM/PLM allows you to manage all stages right from inception and design through completion and use of your application/product, considering changes, new requirements or finding solutions to any encountered problems during the design phase.
FDA 21 CFR part 11
Workflow
Monitoring levels of approval for data or test implementation made easier.
Traceability Matrices
You can define matrix for traceability (simple or star shaped) with a data overall vision (specifications, tests, regulations… coverage).
Statistics
You can create and view numerous types of graphic reprezentations for analysing your data in real time, including calculation formulas.
Automatic Publishing of Reports
Create, automatically publish and record personalized reports.
Client Case Merck®: Digitalization of Forms
Discover how Merck optimized productivity and compliance with GxpManager's no-code platform, saving over 6,000 hours annually by digitalizing critical processes like batch release and form management. Simplify workflows, ensure data integrity, and enhance efficiency.
Learn moreMaster Data Management (MDM)
Digitize data collection, verification, and approval to centralize it in the Master Data Management (MDM).
Learn moreUnused equipment valuation
The application allows for financial gain through resource optimization: internal reuse and external resale of unused equipment. A tailored 'e-commerce platform for refurbished equipment' has been created.
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