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Client

Leading Pharmaceuticals Company

Sector

Pharmaceutical

Technology

Azure

About the Client

Our Client is a leading pharmaceuticals company in India, with the core business interest on developing and delivering a wide range of branded & generic formulations and biotechnology products globally. This global leader in Anti-TB segment; truly emphasizes on innovation and technology, which includes embracing cloud particularly Azure as an engine of their digital transformation.

Business Scenario

As part of its organic growth and multiple acquisitions, our customer ended up owning multiple legacy-messaging solutions in different location. Under invariable pressure to streamline this process with increased efficiency Customer realized that it is time for cloud adoption as it can help them in achieving their digital transformation goals.

Business Requirement

Knowing Microsoft cloud services are built around key tenets of security, privacy, transparency, and compliance our costumer selected Azure (Microsoft hyperscale cloud) as trusted platform for their business- critical applications. However, while considering the use of cloud technology to host GxP computerized systems, our customer wanted to take a third-party assessment approach to ensure that Microsoft Azure can meet their requirements to remain compliant.

8K Miles Approach

To assess the adequacy of the cloud service provider’s (Azure) processes and controls, this leading Pharma corporate found 8K Miles as an expert with deep understanding of standardized policies and procedures. Being a knowledge-based innovation driven company, 8K Miles has been trusted by healthcare, medical devices and pharma companies globally for very long time.

As part of this engagement, 8K Miles has been trusted to perform Due diligence/assessment of the cloud service provider (Microsoft Azure) for qualification and validation of GxP applications.

8K Miles with its comprehensive knowledge in GxP compliance standards (Change Management, Risk Management, Configuration Management, Security Management, Document Management, Data Backup/Recovery procedures) came up with an exclusive assessment report. This includes the production of comprehensive Computerized System Validation Process for complete lifecycle (Concept, Project, Operation, Retirement) while maintaining compliance with GxP.

Results

  • Our Azure GxP Compliance Assessment document was perceived by customer as a gateway to implement a holistic GxP compliant Cloud Infrastructure on Microsoft Azure
  • Our step-by-step approach to define a cloud strategy based on proven practices of existing life sciences Customers comprised of following steps:
  • Assess the implementation of Microsoft’s procedural and technical controls for Azure Cloud platform that is required for cloud compliance and GxP computerized systems validation
  • Identify and list the GxP standards and get relevant Information/Proof in Azure to validate the same
  • Review the Independent Audit Certifications and reports issued for Azure Cloud platform
    As a result of this guidelines document, 8K Miles suggested a detailed strategic model for driving innovation besides maintaining regulatory compliance. This suggested approach helped the customer in their Azure adoption for GxP computerized systems without compromising on strategy security, privacy, transparency, and of course compliance.

About 8K Miles

GxP Compliance Assessment