For any manufacturing that operates 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 the validation process and is one of the criteria used by regulators to measure the reliability of the validation process. To enforce consistent execution of the Validation Plan, ValGenesis has been designed with a Validation Framework function that allows users to define validation standards and deliverable requirements that can be applied to a single or a group of GxP systems.
The Validation Framework function available in ValGenesis allows users to define the required document deliverables that must be completed for any GxP asset to be considered as validated/qualified as per the master validation plan and validation procedure. Validation frameworks provide a mechanism to enforce consistency and compliance across all types of validation processes.
- Define required validation deliverables at the individual asset or group of assets level.
- Enforce deliverable requirements as per the Master Validation Plan (MVP) and/or approved validation procedures.
- Dynamic Regulatory assessment to define and enforce the validation/qualification requirements at the asset or group of assets level.
- Provides complete visibility on the validated status of GxP assets and processes.