Manage the steps of a project and a validation

GxpManager LCM application enables you to manage all steps of a project and a validation work in a dynamic way. You can manage requirements and specifications, risks, create test protocols (IQ, OQ, PQ), execute tests and manage results and validation reports.

Benefits

• Requirement management
• Specifications management
• Import of requirements and specifications from external sources, similar projects, catalogues
• Ensure compliance to GxP, SOx, ISO, ICH, GAMP, …
• Capitalize test activities
• Reduce documents maintenance
• Reduce review cycles
• Reduce execution time
• Coordinate and associate all project team members
  
• Produce dashboards, indicators and metrics

Who should benefit from Gxpm VALIDATION & PROJECT LIFECYCLE?

Project managers, technicians and engineers concerned by project or validation management in the following fields:

• Information Systems
• Validation
• Quality Assurance
• Engineering

Requirements and specifications management

You can enter your requirements and specifications directly into GxpManager LCM. You can also import them from an external file, a requirement catalogue or another Gxpm project.

Test Protocols

The powerful management and validation functions of GxpManager LCM enable to create test documents (IQ, OQ, PQ, FAT/SAT, protocols and reports).

Risk Management

GxpManager LCM eases project and validation management. GxpManager LCM enables you to complete your risk analysis for processes, functions, components, ...

GxpManager LCM takes into account all standard methods (FMEA, HAZZOP, HACCP...) and enables you to customize them very easily according to your needs. GxpManager LCM fulfils all the applicable Healthcare Industry regulatory requirements (FDA, EudraLex, ICH Q9, ...) for Risk Based Approach.

The risk management integrates directly with the validation testing strategy: test cases generation, test results analysis in relation to the concerned risk levels.

Test Execution and Management

GxpManager LCM enables you to manage your entire test documentation: test plans, test sheets, execution reports. You can edit your documents but you can also use the interactive execution feature for your test sheets with the entry of result in the database.

Deviations, test results and reports management

During execution, you can give testers the option to generate a deviation document through a predefined and automatic form related to the test scripts.

Documents, dashboards and indicators editing

With GxpManager LCM you can edit the documents you need for your projects:

• User requirements specification
• Functional Specifications
• Technical Specifications
• Risk Analysis
  
• Validation Plan
  

• DQ Protocol
• IQ Protocol
• OQ Protocol
• PQ Protocol

• DQ Report
  
• IQ Report
• OQ Report
• PQ Report

• Final Validation Report
  

• DQ Execution
  
• IQ Execution
• OQ Execution
• PQ Execution