In the Life Sciences, analyzing vast datasets like genomic sequences or clinical trial results is routine. Ensuring the security and integrity of this data is crucial, especially under tight regulatory oversight.

Amazon Web Services (AWS) provides a platform with certified experts that cater to these needs. AWS offers tools that help streamline data processes, meet compliance standards, and safeguard intellectual property. The key is to use these tools efficiently to maintain data integrity and confidentiality.

AWS’ framework for Life Sciences compliance

AWS solutions are designed to meet the specific demands of Life Sciences, such as upholding GxP compliance and guarding sensitive patient data. By aligning with these requirements, organizations can adhere to regulatory standards while tapping into the benefits of Cloud technology. Moreover, AWS’s voluntary participation in the CSA Security, Trust & Assurance Registry (STAR) Self-Assessment showcases its transparency in compliance with best practices, establishing even more trust for users.

AWS’s commitment to integrating compliance controls means it’s woven through the entire system, from data centers to intricate IT processes. For example, when handling genomic data, AWS ensures encrypted storage for raw sequences, controlled access for processing, and traceable logs for any data transformations, all while adhering to regulatory standards.

Data governance & traceability in AWS

This tailored AWS infrastructure offers Life Sciences organizations unparalleled control. Imagine researchers working on a groundbreaking vaccine. As they collect vast amounts of patient data, they need a system that can not only securely store this information but also track every modification or access to it.Drug Development in Life Sciences

With AWS, an automatic log is generated each time a researcher accesses or modifies a patient’s record. This means that six months later, if there’s a question about who made a specific change to a patient’s data, the researchers can quickly pull up this log, verifying the exact date, time, and individual responsible. Data management on AWS is about ensuring data is traceable, consistent, and always under the organization’s purview.

Ensuring security through AWS best practices

Life Sciences data, whether it’s genomic sequences or computational studies, needs robust security. This data’s sensitivity and proprietary nature mean any breach could harm research outcomes, patient confidentiality, and intellectual property rights.

To tackle these concerns, AWS provides:

  • Encryption at rest and in transit: AWS’s encryption mechanisms shield sensitive data in storage and during transfer, so that critical information like genomic data or computational chemistry results remain confidential and tamper-proof.
  • IAM (Identity and Access Management): Fine-grained access control is essential in Life Sciences to prevent unauthorized data breaches. With AWS’s IAM, organizations can meticulously determine who accesses specific datasets, down to actions they’re permitted to take—be it viewing, modifying, or sharing.
  • VPC (Virtual Private Cloud): Given the sensitive nature of research data, such as precision medicine studies or bioinformatics analyses, an extra layer of protection is often required. AWS’s VPC offers isolated computing resources, enabling organizations to craft custom network architectures that suit their security and compliance needs. This ensures that data remains protected in a dedicated environment.
  • Physical security measures: Beyond digital protections, AWS takes extensive precautions to safeguard the physical infrastructure housing this data. Data centers benefit from tight access control, with staff passing through multiple authentication stages. Routine audits and surveillance bolster the integrity of the physical environment where data resides.

Audit preparedness & continuous compliance monitoring with AWS

Navigating the maze of regulatory requirements in the Life Sciences sector can be daunting. AWS offers tools designed specifically to ease this journey.

AWS Artifact stands out as it provides on-demand access to AWS’s compliance reports. With information at their fingertips, companies can confidently maintain regulatory compliance without the traditional runaround of audit requests.

Further strengthening the compliance arsenal, AWS Config offers a dynamic solution. Rather than periodic checks, AWS Config continuously monitors and records the configurations of AWS resources. For instance, if a Life Sciences firm were to deploy a genomic database, AWS Config would ensure its settings align with internal policies and external regulatory standards. Utilizing machine learning, AWS Config can also predict and alert potential non-compliance issues before they become critical.

This continuous oversight eliminates gaps that might arise between audits, allowing for consistent adherence to the best practices and regulatory norms.

Integrating advanced governance with AWS and Turbot

AWS provides a solid foundation for data management and compliance, but sometimes, specific industries demand specialized solutions. This is where third-party tools like Turbot come into play. It’s tailored for sectors such as Life Sciences thanks to its real-time automation, governance, and compliance features.

Consider a pharmaceutical company conducting clinical trials across multiple countries, each with unique compliance criteria. Turbot ensures that every AWS resource aligns with these diverse regulations, minimizing non-compliance risks.

Beyond mere monitoring, if Turbot detects any discrepancies or non-compliant resources, it immediately rectifies the situation without waiting for human intervention. This proactive approach ensures robust security measures are consistently in place.

Security and compliance in AWS for Life Sciences

Life Science industries operate within complex regulatory landscapes, and handling vast datasets requires meticulous attention to security, traceability, and compliance. AWS’s platform is designed to cater to these needs with sophisticated tools for data governance, security, and audit preparedness, however, without a specialized Life Sciences scientific computing provider with deep AWS expertise, like RCH, you may be leaving AWS opportunities and capabilities in the balance. To maximize the potential of these tools and navigate the intricate junction where science and IT overlap in the AWS Cloud, and beyond, a subject matter expert is crucial.

Contact our certified AWS experts to empower your research with specialized Bio-IT expertise and help streamline your journey to groundbreaking discoveries.


Sources: 

https://aws.amazon.com/solutions/health/data-security-and-compliance/

https://aws.amazon.com/health/solutions/gxp/

https://www.rchsolutions.com/cloud-computing/ 

https://docs.aws.amazon.com/whitepapers/latest/gxp-systems-on-aws/aws-certifications-and-attestations.html

https://aws.amazon.com/health/genomics/

https://aws.amazon.com/solutions/case-studies/innovators/moderna/

https://aws.amazon.com/blogs/aws/introducing-amazon-omics-a-purpose-built-service-to-store-query-and-analyze-genomic-and-biological-data-at-scale/

https://aws.amazon.com/compliance/data-center/controls/

https://aws.amazon.com/blogs/aws/new-aws-config-rules-now-support-proactive-compliance/

https://turbot.com/guardrails/blog/2018/11/healthcare-and-life-sciences

https://turbot.com/guardrails/blog/2018/04/gartner-cspm

https://www.rchsolutions.com/resource/elevated-perspectives-security-in-the-cloud/

RCH Solutions