Question 1

What are the core capabilities of the ValGenesis VLMS?

Accepted Answer

ValGenesis offers a complete suite of features for validation lifecycle management, including risk assessment, test script creation and execution, deviation management, change control, and comprehensive audit trails. It supports both computerized and non-computerized systems validation.

Question 2

How does ValGenesis help with regulatory compliance?

Accepted Answer

ValGenesis is designed to meet the stringent requirements of regulatory bodies like the FDA, EMA, and others. It provides features like electronic signatures, audit trails, and version control to ensure data integrity and compliance with standards such as 21 CFR Part 11 and EU Annex 11.

Question 3

What types of integrations does ValGenesis offer?

Accepted Answer

ValGenesis integrates with various enterprise systems, including document management systems (DMS), quality management systems (QMS), and enterprise resource planning (ERP) systems, to streamline data flow and improve overall efficiency.

Question 4

Is ValGenesis suitable for companies of all sizes?

Accepted Answer

Yes, ValGenesis is scalable and can be adapted to meet the needs of both small and large organizations. Its modular design allows companies to implement only the features they need, reducing costs and complexity.

Question 5

What kind of training and support is available for ValGenesis users?

Accepted Answer

ValGenesis provides comprehensive training programs, including online tutorials, instructor-led courses, and on-site support. A dedicated customer support team is also available to assist users with any questions or issues.

Question 6

How does ValGenesis improve the efficiency of the validation process?

Accepted Answer

By automating many manual tasks, centralizing validation data, and providing real-time visibility into the validation lifecycle, ValGenesis significantly reduces the time and cost associated with validation activities.

Question 7

Can ValGenesis be used for both process and system validation?

Accepted Answer

Yes, ValGenesis is designed to support both process validation and system validation, providing a unified platform for managing all aspects of the validation lifecycle.

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