• Life Sciences Cloud

 
 
 

Cloud Compliance

For life science companies, moving to the Cloud is much more than a data storage decision. Life science organizations also need to be compliant with government regulations worldwide, including HIPAA and 21 CFR Part 11. The USDM Life Sciences Cloud team specializes in providing compliant cloud solutions designed specifically for the life science industry and validation services for cloud applications.

Cloud systems are based on a standard set of system configuration, pushed out to all customers. This standard baseline and the regularly scheduled system updates can be swiftly and painlessly validated utilizing the Cloud Assurance Validation Accelerator Pack (VAP). The USDM Cloud Assurance VAP and compliance methodology provides life science companies with an industry best practice tool to simplify compliance, increase productivity and minimize costs. The USDM VAPs have been used successfully in the industry for more than a decade.

Customers build upon the standard system baseline to enhance the system to fit their specific needs. Depending on their intended use and inherent risk, these enhancements may be subject to additional validation activities to ensure continued adherence to applicable regulations.

USDM’s Cloud Compliance team can help you determine the associated risks, create the required suite of documentation, verify that the system meets all requirements and deliver a validated solution including all associated system governance and processes (such as Change Control & System Maintenance).

To help with Cloud Compliance, USDM’s Cloud Development team can deliver the specific configuration and customization necessary to build and enhance your cloud system. Our Cloud Development team provides best practice business process services based upon extensive experience in cloud computing for Life Sciences companies.

 

Achieving Cloud Compliance

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Testimonials

  • Clintrak - Jeffrey D. Coffin
    I have had the great pleasure to work with Bob for 5 years in his position of VP of Quality at Fisher Packaging Services while I acted as Director of Quality services at a sister…
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