Overview
Ensuring GxP (Good Practice) compliance is essential for biopharma companies, covering regulations like Good Manufacturing Practices (GMP), Good Clinical Practices (GCP), and Good Laboratory Practices (GLP). DNAnexus, a platform-as-a-service tailored for the life sciences industry, offers scalable cloud-based solutions that streamline compliance with regulatory standards such as 21 CFR Part 11. This brief outlines how DNAnexus addresses key GxP-related challenges, ensuring the security, integrity, and compliance of biopharma data and pipelines.
- Handling Failed Validation Tests
During validation, DNAnexus identifies and addresses failed low-priority tests by leveraging comprehensive regression testing for each release. Manual testing is conducted when needed, and failed tests (deviations) are documented in the Specification Testing Report. The Change Control Board (CCB) assesses the deviation and determines the next steps, which may involve reverting the functionality to the last working state or delaying the production release if the failure is critical.
Key Benefit: DNAnexus ensures high standards by preventing unvalidated or malfunctioning functionality from reaching production, reducing compliance risks for users.
- Managing Third-Party Dependencies
DNAnexus handles dependencies on third-party tools such as Nextflow by supporting multiple versions of applications. This approach ensures that users do not have to revalidate pipelines with every update. When third-party components present security vulnerabilities, DNAnexus communicates directly with impacted users, providing workarounds or patches to minimize disruption.
Key Benefit: Flexibility in managing third-party dependencies reduces the burden on users while ensuring the integrity and security of pipelines.
- Security and Compliance
Security is a top priority for DNAnexus. Regular security patches are applied to Docker containers (weekly) and compute instances (monthly), with critical vulnerabilities addressed within 30 days. The platform complies with regulations like HIPAA, GDPR, and FedRAMP, ensuring data protection and regulatory compliance globally. DNAnexus also supports disaster recovery with annual recovery exercises ensuring recovery time objectives (RTO) of 8 hours and recovery point objectives (RPO) of 4 hours.
Key Benefit: DNAnexus ensures high availability, data protection, and compliance with international regulations, minimizing risk for users.
- Supporting Regulatory Audits
DNAnexus participates in more than 80 audits annually, including FedRAMP, FISMA, and ISO certifications. The platform supports users during their regulatory audits, offering comprehensive documentation and evidence of compliance. DNAnexus can also be directly involved in customer audits, streamlining the process and reducing the burden on users.
Key Benefit: Robust audit support helps biopharma companies efficiently navigate regulatory inspections and ensures compliance readiness.
- Computer System Validation (CSV)
CSV is essential for biopharma companies using cloud-based systems for drug development. DNAnexus supports 21 CFR Part 11 compliance by offering a validated environment for managing data and pipelines. The platform automates many aspects of the CSV process, reducing the time and complexity involved in maintaining validated systems.
Key Benefit: Automation of CSV processes allows users to focus on core scientific work rather than manual validation tasks.
- Best Practices for GMP Pipelines
DNAnexus is actively developing internal codebase templates used for GMP-compliant pipeline development. While the Professional Services team currently uses this codebase, DNAnexus is working towards finalizing and sharing these templates with external users. This documentation will assist biopharma customers in building and maintaining GMP-compliant workflows on the platform.
Key Benefit: Provides the foundation for users to confidently build GMP-compliant pipelines, reducing regulatory overhead.
- Pipeline Validation Optimization
Pipeline validation timelines depend on the complexity and structure of the pipelines. DNAnexus offers strategies to expedite the process by validating core pipelines and reusing validated components for subsequent workflows. With the availability of a validation template project, DNAnexus helps users reduce validation time, especially for recurring pipeline structures.
Key Benefit: Streamlined validation processes can save months of effort, accelerating time-to-market while maintaining compliance.
Approximately 50% of DNAnexus pharma customers opt for GxP-validation support with DNAnexus
Conclusion
DNAnexus offers a scalable and compliant cloud platform for biopharma companies, addressing the unique challenges of GxP compliance in drug development. By providing comprehensive tools for validation, security, and audit support, DNAnexus helps biopharma organizations maintain regulatory compliance while accelerating drug discovery and development.
