PI validation projects carried out in several pharmaceutical corporate sites allowed PQE to gain solid knowledge about the Validation Strategy to be applied to this typology of systems, reducing efforts and costs by ensuring solid and established quality standards.
A brief overview of the distinguished global and local approach is described below to highlight the benefits of a middle strategy known as “Glocal.”
A local validation provides site-specific PI installation and qualification phases through a customized model based on a predefined set of documents, involvement of stakeholders and application of procedures focused on local users and features. This solution is a good option when, for example, only one or few sites of a company choose the PI as the data’s historical system and no replication needs to be implemented in other sites. This approach could be useful for stand-alone systems that do not take advantage of the extended involvement in terms of data global access.
A global approach is certainly more useful for complex systems or when the major value of the system usage reflects a global impact on multiple sites. A pure global validation can include a global environment and a set of standard tests that are not replicated in the applicable sites or that can be applicable for a cloud platform configuration.