Sotero Achieves Prestigious GxP Validation

Sotero makes the power of its Data Security Platform available to pharmaceutical and healthcare organizations to optimize their handling of high-risk data.

Sotero, a leading data security company, is proud to announce that Sotero’s cloud-native data security platform is validated to support GxP regulated computerized systems and environments.

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“Maintaining best practices such as GxP is essential for ensuring compliance and enabling safe development of pharmaceutical and healthcare products,” says Sotero’s Co-Founder and President Purandar Das. “Sotero’s Data Security Platform takes a unique, holistic approach to maintaining good practices. Instead of just delivering on one facet of the GxP process, it ensures the data is protected at all stages of use, including storage, and sharing with downstream systems for analysis while automating the tracking of data utilization and modification.”

GxP is a collection of organizational processes for Pharma and Medtech involving data collection, handling, and tracking throughout the organization set by The International Organization for Standardization (ISO). It helps organizations demonstrate that they adhere to high standards for producing and developing medications, vaccines, and medical devices. Certification validates they have achieved these exacting standards.

GAMP®5: A Risk-Based Approach to Compliant GxP Computerized Systems Guidance provides a risk-based framework for the validation of computer systems. With this, each customer receives the documentation required to easily approve Sotero’s technology in their restricted environment.

“Sotero has experience integrating with Pharmaceutical organizations working to achieve their own GxP certification. With the Sotero Data Security Platform, organizational IT worked directly with Sotero to deploy, test, and validate the platform and see operational results in a matter of weeks. Companies not only managed to achieve GxP certification, but they also realized faster drug development” said Shanthi Boppana, Co-Founder and CTO of Sotero.

With Sotero’s Data Security Platform, organizations can quickly and easily integrate it into their GxP regulated environments rather than going through cycles of testing and validation.

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