WebCenter Validation
Esko delivers a fully validated system with templates for all deliverables.
Validation Process
Heavily regulated sectors such as Pharmaceuticals and Medical Devices require an Artwork Management System to be validated. Validation assures a computerized system does exactly what it is designed to do in a consistent and reproducible manner.
Validation Process
Validation Plan
Create a high-level plan, including the roles and responsibilities for all activities.
Requirements Specification
Identify all necessary system features and functions.
Design Specification
Outline the detailed design of the system needed to meet requirements.
Testing
Verify every aspect of implementation, including IQ, OQ and PQ (Installation, Operational and Performance Qualification).
Validation Report
Summarize the validation process as part of the implementation audit trail.
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