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.
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.
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.
To assess the adequacy of the cloud service provider’s (Azure) processes and controls, this leading Pharma corporate found SecureKloud as an expert with deep understanding of standardized policies and procedures. Being a knowledge-based innovation driven company, SecureKloud has been trusted by healthcare, medical devices and pharma companies globally for very long time.
As part of this engagement, SecureKloud has been trusted to perform Due diligence/assessment of the cloud service provider (Microsoft Azure) for qualification and validation of GxP applications.
SecureKloud 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.
Leading Pharmaceuticals Company