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Validation Module©
Novatek’s Validation Module is a software application used to track and manage any type of validation process including; cleaning validation, computer validation, process validation, equipment qualification and validation.

The Validation software Complies with 21 CFR Part 11, Annex 11 and other key regulatory requirements.

It allows defining various validation steps within a protocol. The Steps are managed and controlled through the Validation Software. Revisions and modifications made to the protocol are versioned, reviewed and approved by authorized personnel within the application.

The Validation software works in conjunction with text editors to allow for protocol setup as this is natural to most users. It synchronizes its database with the text editor and track any modifications made in an independent audit trail. This provides for a user-friendly process while incorporating the necessary 21 CFR Part 11 security.

Tracking and scheduling of the defined steps and its status, based of test specification details. Tracking of test results and notifications for out of specification values. Root-cause analysis can be performed through the use of investigations, trending, and charting.

Novatek VA. Benefits

• Increased efficiency and productivity
• Eliminates manual verification and reduces human errors
• Secure validation documents from unauthorized changes.
• Track and manage validation document version numbers.
• Statistical functionality to give early warning of manufacturing quality deviations
• Prevent costly shutdowns and manufacturing delays.
• Fast implementation, IQ/OQ validation, ease of upgrade and support.
• Manages all validation types
• Works in conjunction with a text editor .