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Validation Plan and Framework

To enforce consistent execution of the Validation Plan, ValGenesis VLMS is designed with a Validation Framework function that allows users to define validation standards and deliverable requirements that can be applied to one or more GxP systems.

Validation Plan and Framework

For any manufacturing enterprise operating in the regulated life sciences environment, one of the biggest challenges is maintaining a consistent approach across different validation processes and sites. Consistency is a key factor in any validation process and a crucial part of the criteria by which regulators measure the reliability of any validation process. To enforce consistent execution of the Validation Plan, ValGenesis VLMS is designed with a Validation Framework function that allows users to define validation standards and deliverable requirements that can be applied to one or more GxP systems.

Our Validation Framework function provides a mechanism for enforcing consistency and compliance across all types of validation processes:

Complete visibility with real-time validation status for GxP assets and processes

Define required validation deliverables at the individual asset level or grouped assets level

Define and enforce validation / qualification requirements at the asset level or grouped assets level with dynamic, decision tree regulatory assessments

Enforce deliverable requirements as per the approved Master Validation Plan (MVP) and validation procedures, which are typically buried in documents

ValGenesis Validation Lifecycle Management System Modules

Validation Plan and Framework is a fully integrated module for ValGenesis VLMS, the most complete digital validation system.

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