Challenge: GxP compliance in a cloud-based biometrics environment
A leading biotechnology company focused on innovative therapeutics faced challenges in achieving and maintaining compliance in its cloud-based biometrics computing environment. Ensuring alignment with GxP standards, FDA 21 CFR Part 11 requirements, and other regulatory obligations was essential for their operational and research functions.
The biotechnology company sought a partner to provide expert guidance in validating its AWS Biometrics Computing Environment, SAS applications, and RStudio/Shiny platforms to meet rigorous compliance standards while optimizing operational efficiency. Qualifying a cloud platform for regulated research demands a disciplined approach to data integrity, security, and traceability.
Approach: A comprehensive qualification and validation program
USDM Life Sciences provided a comprehensive solution to address the customer's validation and compliance needs, applying risk-based software assurance across three platforms and structured regression testing.
1. AWS Biometrics Computing Environment qualification
- Deliverables: Development of a Validation Plan (VP), System Requirements Specification (SRS), Configuration Operational Qualification (COQ), and a Validation Summary Report (VSR); creation of a User Administration SOP for the AWS platform; and traceability through a Requirements Traceability Matrix (RTM).
- Focus areas: Compliance with FDA 21 CFR Part 11, data privacy, and security regulations, with risk mitigation through detailed risk assessment and COQ test scripts. Validating cloud platforms also reinforces sound third-party risk management over the underlying infrastructure.
2. Validation of SAS
- Deliverables: Validation Plan (VP), SRS/Risk Assessment, Operational Performance Qualification (OPQ) test scripts, and a comprehensive Validation Summary Report.
- Focus areas: Ensuring SAS's validation for high compliance standards while leveraging existing configurations to optimize performance qualification.
3. Validation of RStudio/Shiny
- Deliverables: Development of SRS documents, OPQ scripts, and a Validation Summary Report.
- Focus areas: Streamlining validation to address the specific needs of the RStudio/Shiny platform while maintaining clear alignment with regulatory standards.
4. Regression testing
- Deployment of specialized cloud and software test engineers for test execution, ensuring the accuracy and reliability of all qualification processes.
Results: Validated platforms and a continuous compliance model
Regulatory compliance: Successfully qualified and validated the AWS Biometrics, SAS, and RStudio/Shiny environments, aligning with global GxP and FDA 21 CFR Part 11 requirements.
Operational efficiency:
- Delivered key documentation, such as validation plans and summary reports, enabling streamlined compliance efforts.
- Freed up internal resources to focus on other business priorities.
Cost-effective execution:
- Optimized resource use with a fixed-price model and clear deliverable milestones.
- Mitigated risks and reduced potential delays through efficient planning and collaboration.
Continuous compliance:
- Established a sustainable compliance model through SOPs, ensuring ongoing alignment with regulatory changes. Pairing this with USDM Cloud Assurance keeps validated cloud platforms compliant as they evolve.
By providing expert guidance, seamless collaboration, and scalable solutions, USDM Life Sciences enabled this biotechnology company to achieve its compliance objectives efficiently and effectively. They not only met their immediate validation goals but also established a robust foundation for sustainable compliance and operational excellence.