Improve the cost and reduce delivery time for your projects thanks to a performing quality and risks management.
GxpManager allows to create tailor-made solutions for Quality, Validation and Engineering projects. Implement best practice with powerful, fast and easy to use solutions without programming.
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Audit Management
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Training Management
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Backup and Continuity plan
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Batch records filing
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CAPA Management
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Quality Assurance
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Regulatory Monitoring
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Management of deviations
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Health Safety and Environment (HSE) Requirements
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Management of repositories, regulations and standards
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Site Master Plan
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Management of Excel© spread sheets
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Change Management
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Validation LifeCycle Management
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Validation Master plan
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Validation of computerized systems
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Validation of equipment and processes
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Validation of processes for manufacturing of medical devices
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Infrastructure Qualification
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Risk Analysis and Management
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Requirements and specifications management
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Anomalies Management
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Protocols Management (DQ, IQ, OQ, PQ)
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Execution of tests
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Impact catalog
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Change Control
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Revalidation
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Software Engineering
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Facilities Engineering
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Medical Devices Engineering, DHF, DMR
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Process and equipment Engineering
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Transfer of activities (Production and Laboratories)
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Definition of needs,Preliminary design studies, Final design studies
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Management of technical and functional specifications
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Management of completed and delivered versions
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Configuration Management
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Risk Analysis and Management
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Non-compliance and anomalies Management
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CAPA
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Management of reception testing
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Commissioning
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Management of metric
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Project monitoring
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Change Management
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Planning of ressources and activities
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Budget management and implementation monitoring
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General planning of activities and Roadmap
Events
GxpManager is actively supported by OSEO and the ERDF (European Regional Development Fund) of the Rhone-Alpes region.