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Solution's Architecture
“GMP Management System” represents the GxP Data Repository, to handle data produced by the different Company's Processes, typical of a regulated environment, but is even the engine for a correct Data management, which utilises configurable logics, which has been developed compliant to both, Regulatory Requirements and Production Site's Policies. |
| GMP Management System |
• GMP Data Repository
Data Archive |
• GMP Rules Engine
Processes's Rules |
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System's features
GMP Management System even provides the Main System's Features, as Security, Access Controls, common rules available for the different modules. |
Some Common
Functions:
• Authentication
• Electronic Signatures
• Workflow Management |
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Furthermore, other common Functions are available for the “Systems's Modules”, even if different depending by Users Profile: |
System's Administration Tools
Centralised Repository
Data Security Rules
User's Profile for:
Access Control
User's Profiling
User Group's Management
Electronics Records Management Rules |
Time Stamp & Electronic Signature
Audit Trail
Configuration Traceability (Audit Trail)
Workflow (managed in graphic mode)
Document's Master & Template Management
Data Governance Rules (Access - Separation - Maintenance)
Access to GMP Data, based on User Profiles. |
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