Validation
Esko Can Support You to Work within the Regulations of a CGMP Compliant Environment
For many years, Esko has provided validated services to regulated customers. A validated WebCenter implementation adheres to standard implementation operating procedures that pre-define the step-by-step processes for planning, designing, building, testing, training, and deployment. Esko also offers a validation package of templates, modeled after the GAMP 5 (Good Automated Manufacturing Practice) Guide for Validation of Automated Systems to yield properly documented evidence and traceability to demonstrate that WebCenter has been validated and is fit for its intended use.
Esko implementation procedures and validation package meet the utmost standards within highly regulated and validated environments and are fully supported by our Quality Management System – helping you efficiently maintain compliance with both internal policies and government regulations.
Esko Delivers Validation Services
Validation services from Esko provide a high degree of assurance that WebCenter will function according to the requirements you set forth. These services begin with a Validation Plan, which outlines the approach for how validation will be achieved and maintained through properly documented and controlled specifications and qualification activities.
Esko Achieves Traceability
Esko WebCenter maintains traceability through:
- User requirements specification
- Design specification
- Testing
During the planning phase of an implementation, we work with you to clearly define roles and responsibilities for all aspects of the project. These responsibilities include required activities for system qualification, such as:
- Installation Qualification (IQ)
- Operational Qualification (OQ)
- Performance Qualification (PQ)
As part of deployment, we also work with you to ensure WebCenter end users are fully trained and appropriate procedures are in place for operational maintenance and change control.
Esko Helps You to Achieve Compliance
The end result is a workflow management system that enables you to adhere and adapt to US FDA, EU EMA, and other government regulations regarding audits, system validations, audit trails, electronic signatures, and documentation.
