Ensured compliance with GxP, SOx, ISO, ICH, GAMP…
Description
Key features
Resources
Use Cases
Description
- 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.
Key features
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.
Resources
Use Cases
Use cases
Digitize Paper Forms
Digitize more than 1000 paper forms without altering the content and signature processes...
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Master Data Management (MDM)
Digitize data collection, verification, and approval to centralize it in the Master Data Management (MDM).
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Unused equipment valuation
Alongside an activity interruption program for which GxpManager provided a project management application
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