Life Sciences 

With the layers of regulations, it is easy to become overwhelmed by life science compliance requirements. However, your organization’s efficiency and time to market depend upon the ability to prioritize essential validation and qualification requirements over less critical activities. GxP-CC delivers this critical insight, helping leading life sciences organizations around the globe to streamline compliance and strengthen operational efficiency.  

We partner with life science companies at every phase of product development, supporting the full lifecycle of computerized systems. With the support of our experts’ extensive experience in the industries they now serve, we are able to tailor solutions that achieve organizations’ unique challenges. We deliver solutions that strengthen organizational standards with industry best practices to streamline processes, provide more valuable insight, reduce risk, and simplify compliance.

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How ISO 27001 certification ensures data integrity
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Common Data Integrity Points of Failure: 3rd Party Management
Webinar
Data Integrity in Pharmaceutical Manufacturing, March 23, 2023 – Recording available
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Highlights of the Concept Paper on the revision of Annex 11
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Ensuring GAMP Compliance and Strategies to better manage your Computerized System Life’s Cycle according to ISPE GAMP5 2nd Edition
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Data Integrity in GCP
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Data Integrity in GCP
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3 Risks to Your Laboratory Equipment’s Qualification Status
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How Critical Thinking Can Improve Computerized Systems’ Compliance
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Better Balance Efficiency, Security for GAMP 5 Category 1 Infrastructure Software
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Best Practices for Implementing AI and ML Technology in a Regulated Environment
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How to Implement Blockchain in GxP Regulated Environments
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