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Enhancing Regulatory Compliance for a Pharmaceutical Manufacturing Company

Using PTC’s ThingWorx Solution in a GxP Regulated Environment

Learn how USDM seamlessly validated DocuSign

A pharmaceutical company specializing in developing products for the acute treatment of medical conditions faced challenges managing its extensive collection of documents, including training records and internal forms.

The company needed an electronic document signing and management system to streamline its documentation processes and maintain compliance with the FDA’s 21 CFR Part 11 regulations. The company recognized the benefits of using DocuSign but faced the challenge of ensuring that DocuSign could be fully validated to meet regulatory requirements.

The pharmaceutical company engaged USDM as the trusted validation partner to address its challenges. USDM’s team of experts fully validated the DocuSign system, including a comprehensive Validation Plan, Installation Qualification, Performance Qualification, and a Validation Final Report.

Following the implementation and validation efforts led by USDM, the pharmaceutical company successfully addressed its electronic document signing and management needs while maintaining compliance with the FDA’s regulations.


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