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11/9/15 Pharmaceutical Company contracts CSols for Empower 3 Validation

November 9, 2015

A specialty pharmaceutical company is in process of upgrading their Waters Empower 1 CDS to Empower 3. For this project, the client required a Software Validation Consultant to review the current validation lifecycle documentation for Empower 1 and provide guidance for the upgrade. CSols was chosen for their Domain and Regulatory expertise, as well as their deep experience working with Waters Empower. CSols will be supporting the validation activities by creating a Validation Assessment Report to identify the existing gaps in the Empower 1 validation and identify corrective actions required to validate Empower 3, based on industry best practices and GAMP 5 guidelines for a configurable system.


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