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Enterprise Validation Management Solution (EVMS) is designed to automate, manage, and track the entire validation process from generating validation document numbers to online execution of validation documents.
ValGenesis is the ideal solution to improve the efficiency of the entire validation process, enhance the quality and consistency of validation documents, provide a valuable line of defense against internal or regulatory audits and inspections, and reduce the overall costs of validating entities.
Die Enterprise Validation Management Solution (EVMS) managed, automatisiert und dokumentiert lückenlos den gesamten Validierungsprozess. Download data sheet PDF (2100 Kb)
 VALIDATION MANAGER
Manages all master data objects and provides configuration of validation processes and system definitions.
- User groups, roles and privileges
- Validation types, nomenclature, classification hierarchy, and workflows
- Document numbering schema, e-signature requirements and audit trail definitions
- Template development and traceability assignments
- Cost and time definitionsrgaben
 REQUIREMENTS MANAGER
Manages all requirement details as well as many-to-many assignments between all document objects.
- Requirements management
- Definition of various traceability matrices
- Many-to-many assignments
- Visibility of test status and progress
 VALIDATION PLANNER
Defines all validation and project plans as well as the structure of all validation activities.
- Validation plan
- Maintenance plan
- Regression plan
- Project plan
- Management of validation activities and deliverables
- Label print for all validation objects for online status checks
 EXECUTER
Portal for electronic test execution as well as review and approval activities.
- Electronic test execution
- Alternatively – import of manual test protocols and external data sources
- Test review and approval Electronic archive and electronic signature
 DEVELOPER
Development of all documents and test scripts.
- Development of documents based on templates
- Definition of all serial and parallel review and approval workflows
- Peer review options
 ASSESSMENT
Management and assessment of all test errors.
- Define deviations
- Categorize errors
- Create error lists
- Initiate regression tests
 SCHEDULER
Scheduling of one-time and periodic test activities.
- Planning of all test execution tasks
- Assignment of test resources
- Definition of repeat cycles and test activities
ValGenesis is the ideal solution to improve the efficiency of the entire validation process, and to enhance the quality and consistency of all validation documents. |
