VALIDATION SERVICES

A validation assessment program is a necessity in the pharma industry to ensure adherence to pharmaceutical cGMP guidelines, and to help companies maintain consistent quality. The same principles are applied in computer system validation to a computer system or an information technology system.

Deliverables

• Regulatory Applicability Assessment Report (As required)

• Requirement Traceability Matrix

• Test Plan and Test Evaluation Report

• Error Validation and Resolution Report

• Final Test Report: IQ and OQ Report

• Regulatory Compliance Assessment Report (As required)

• Standard Operating procedures (as required)

• Training the resources as applicable

• Validation Summary Report