GxP S3 Compatible Object Storage Service

FDA Qualified Validated Cloud’s GxP Object Storage

(AWS S3 and Azure Blob Compatible)

Validated Cloud’s GxP Object Storage (S3 and Blob Compatible) is available to hold validated data for the life science industry. Our solution is fully qualified in accordance with the United States Food and Drug Administration (FDA), European Medicines Agency (EMA) and Medicines and Healthcare Products Regulatory Agency (MHRA) standards for compliance. Validated Cloud’s GxP Object Storage service for GxP and validated data can be used in a variety of ways:

- GxP/validated data archive
- GxP/validated data lake
- Validated clinical data sharing between sponsors and CROs
- Off-site storage for GxP lab data, manufacturing data
- GxP storage for validated next-generation sequencing (NGS) data
…and many more uses.

Validated Cloud’s GxP Object service is limitlessly scalable and highly secure with military-grade security, and its integration is seamless and simple. Validated Cloud’s GxP Object service comes fully GxP-compliant out of the box without any additional work needed by our customers to achieve compliance and a fully secure solution.

GxP/Validated S3 Data archive:

Move your company’s validated archive data to a read-only GxP S3 bucket for a secure, inexpensive long-term storage medium. Control access at a granular level simply and effectively. We’ve simplified the GxP S3 platform to make it easy to use, and we provide complimentary guidance designed to make anyone capable of leveraging our excellent GxP S3 service platform.

GxP/Validated Data Lake:

The Validated Cloud GxP S3 storage in conjunction with the fully FDA-compliant out-of-the-box provisioned servers provides a perfect environment for a truly GxP-compliant data lake. Store validated structured or unstructured data simply and easily. Access the GxP S3 bucket from anywhere or from a fully compliant clinical data workspace.

Validated Clinical Data sharing between Sponsors and CROs:

The easy-to-use granular security settings for GxP S3 buckets allow sponsors and CROs to share data quickly and easily without any chain of custody issues. It is easy to pull clinical data into clinical software platforms (e.g., SAS®, RStudio®, Python, Spotfire and more).

Offsite storage for GxP lab data, manufacturing data:

GxP S3 compatibility is quickly becoming a standard component of pharmaceutical and biotech software. The Validated Cloud GxP S3 service is fully compatible with these standards. This integration gets the data or a copy of your critical data off-site for archiving, data protection and as a data integrity repository.

GxP storage for validated NGS data

Validated Cloud’s GxP S3 storage is the solution for the complex needs of storing validated NGS data. Whether your company is storing reference data or the entire genome, Validated Cloud’s infinitely scalable storage is designed to meet the complex NGS needs of storage, security and scalability.

Validated Cloud’s GxP Object service platform (S3 and Blob compatible) was put in place to be compliant with the FDA, EMA and MHRA, with options for geographic redundancy. Our solution simplifies the environment for our users, and we’ve put up the guardrails to help keep our customers out of trouble to stay in compliance.