Platform-as-a-service for data analytics based on Microsoft Azure
Validation, Compliance and Qualification Management
Data Platform (DP) is a PaaS solution for Data analysis based on Microsoft Azure services. The system handles business critical data and allows collection and processing of various business units, as well as exporting of Analytical models and Power BI reports. Data Platform serves as a basis for development of Business applications for data processing. The intended use of the Platform covers both GxP and non-GxP cases, therefore it was developed and assessed with careful consideration towards Validation and Compliance practices in the pharmaceutical industry. Areas such as privacy, backup and restore, availability and regulations were extensively inspected and carefully implemented to ensure business continuity, high availability, and security.
Our role in this project is to create, assess, manage, and approve documentation and testing processes related to validation and qualification activities. By ensuring traceability between design specifications and user requirements, and by extensively testing the system and documenting the results, we ensure the Data platforms’ performance and compliance meet the industry and our client’s standards.
Our contribution to the project falls into 3 main categories:
- Validation and compliance documentation
- Quality and Qualification plans and reports, Design specifications, User requirements and extended processes for Business applications on top of the Data platform
- Functional and Installation qualification of the implemented Microsoft Azure resources
- Azure Data Factory and Lake, Synapse workspace, SQL server and Database, Analysis service
- Test management in Azure DevOps
- Test creation, traceability, and test runs execution
Benefits of the project
Data platform enables our client to efficiently collect, transform and analyze data from various departments such as Finance and HR. Each business case is covered by a standalone application on top of DP, which support improved segregation and understanding of internal processes, projects and clinical trials. By utilizing role-based access controls, both internal and external employees are ensured to have appropriate access only to data and features related to their role, which enables for a secure, transparent efficient and workflow. Due to the manner in which implementation and validation is handled, our client is able to expand the use case of Data platform at any time to fit new GxP business cases, and also outsource it for external use.