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GxP Letter

GxP compliance is a set of quality assurance regulations and guidelines applicable to industries that manufacture, test and distribute pharmaceuticals, medical devices and other regulated products that are consumed or used by humans or animals.

Informatica's software can be deployed/used across industries governed by GxP regulations, notably in sectors like pharmaceuticals and healthcare. However, Informatica's own operations fall outside the purview of GxP regulations. We specialize in crafting solutions to help our Customers adhere to the GxP standards. For example, Informatica's MDM SaaS solution includes functionalities dedicated to data validation, monitoring data quality and managing audit trails – all pivotal elements of GxP compliance requirements. 

Moreover, the Informatica GxP letter offers our customers comprehensive assurance that controls covering security, confidentiality and availability principles are in place. It specifically addresses the configuration and utilization of products to ensure alignment with GxP regulations, focusing on its MDM Hosted and MDM SaaS products.

 

 

Disclaimer: Use of these reports is restricted and requires an NDA to be in place with Informatica before the reports can be distributed.
If you are a customer, please use your Informatica credential to log in and download the report. If not, please contact Informatica support or your account rep for a copy of the report.

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Hosted MDM Letter

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MDM SAAS Letter

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