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Security. Compliance. Quality.

Choose the platform that meets the industry’s most stringent requirements.

 

Future-Proof Compliance

Your data is sensitive. That’s why DNAnexus helps you remain compliant with the latest regulations, standards, and industry frameworks. We understand the overlap of control points and the congruence of security, privacy, and quality design principles to keep your data safe and sealed. We stay up-to-date with changing policies and regulations so you can focus on unlocking the potential of precision health data to drive scientific breakthroughs.

 

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  • Platform Security Architecture
  • Access Control
  • Consistency of Results
  • Availability
  • Quality System Regulations & Assessment
  • Global Privacy

Platform Security Architecture

Platform Security Architecture

Secure multiomics analysis and reproducible science. Confidently manage multiple data types and user access levels

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    High-security facilities

    In compliance with regulations, DNAnexus restricts user data to high-security facilities to prevent physical data tampering or theft
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    Data Encryption

    Rest assured that your data are protected at all times. All data is encrypted when in transit and at rest
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Access Control

Access Control

Confidently control who has access to data. Fine tune data access controls to ensure compliance

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    Administrator Controls

    Administrator controls allow granular privilege levels to be specified on groups of data and application resources
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    Download Disablement

    Downloads can be disabled to comply with data localization requirements
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Consistency of Results

Consistency of Results

Ensure consistent analysis while tracking compliance. Create pre-set analysis methods and/or parameters to ensure the same results each time

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    Preconfigured Pipelines

    Preconfigured pipelines allow bioinformaticians to pre-set parameters to ensure consistent analysis of samples
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    Audit-ready Platform

    Comprehensive features enable audit trails necessary to document compliance
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Availability

Availability

Access the full scope of your data, when and where you need it. Ensure that your data are available to your users within a highly reliable platform

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    Durable & Available

    All user data is redundantly stored across multiple facilities to provide 99.999999999% durability and 99.99% availability
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    Reliant & Redundant

    Consistent with ISO 27002:2022 controls, DNAnexus has reliable disaster recovery and incident response plans and processes, which are tested regularly
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Quality System Regulations & Assessment

Quality System Regulations & Assessment

Quality controls and management keeps data safe in a validated and compliant system. Easily align with the regulations in the countries where you operate

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    Computer System Validation

    To streamline your compliance efforts, computer system validation is used by DNAnexus for product validation and is also available to GxP customers
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    Compliance & Assessment

    To ensure your system quality and compliance, DNAnexus has regular third-party audits evaluating security, privacy and regulated quality controls and management systems
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Global Privacy

Global Privacy

Manage privacy and maintain compliance anywhere in the world. DNAnexus complies with several international privacy and security regulations

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    General Data Protection Regulation (GDPR)

    Simplify your management of GDPR compliance by allowing DNAnexus to act as your data processor
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    International

    As your partner in privacy compliance, DNAnexus will ensure that privacy policies align with the regulations of the countries where you operate in addition to those in the European Union and United States
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DNAnexus GxP Support Services

As you develop a drug or medical device, you’re focused on making it effective and safe. But to bring it to market, you also need to show regulators that you’ve met all best practice standards, at every stage. Documenting this can be difficult and time consuming. Even small mistakes can cause regulators to flag your application.

DNAnexus GxP Support ensures that your bioinformatics work is compliant with all best practice standards. Demonstrate to regulators that you’re observing the full range of GxP guidelines — from documentation, to testing environments, to Quality Management Systems, and auditability. And with DNAnexus GxP Support, you also get help with training, system setup and configuration, and both internal and external audits. We ensure that your drug or device development work complies with best practice standards, at every stage.

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  • GAIN TRACEABILITY

  • Get validated tools, documentation, and training to demonstrate traceability of all work done on DNAnexus. Leverage audit features to meet 21 CFR § 820, 21 CFR § 11, and other requirements. Bring custom-developed applications into compliance with these requirements. 
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  • ESTABLISH ACCOUNTABILITY

  • Provide regulators with fully accountable documentation for all processes on DNAnexus. Ensure you can show exactly who contributed to each process, how, and when - as documented in a complete, human-readable audit trail, updated every 24 hours.

     
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  • ENSURE DATA INTEGRITY

  • Ensure compliance with data integrity and security regulations such as 21 CFR § 11. Get expert assistance to safeguard your data while keeping it accessible and ensuring data provenance. Leverage project-level access controls and the ability to lock pipelines. 

     
     

Meeting Global Standards of Data Privacy and Protection

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CyberPlus
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FDA Selects DNAnexus to Power precisionFDA Collaborative
Omics Environment in the Cloud

The partnership enables FDA to enhance precisionFDA capabilities for sponsor-reviewer interaction, add support for multi-omics, and provide a library of analytical, statistical, and machine learning applications, accessible to reviewers and powerful enough for bioinformaticians.

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Interested in learning more?