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 a 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 a single or a group of GxP systems.
Our Validation Framework function provides a mechanism for enforcing consistency and compliance across all types of validation processes:
Define required validation deliverables at the individual asset level or grouped assets level.
Enforce deliverable requirements, as per the Master Validation Plan and/or approved validation procedures.
Dynamic, decision tree driven regulatory assessment to define and enforce validation/qualification requirements at the asset level or grouped assets level.
Enforce deliverable requirements as per the approved Master Validation Plan (MVP) and validation procedures, which are typically buried in documents.
Complete visibility of validated status for GxP assets and processes.