LSOPS01-BP01 Regularly identify and classify applicable regulatory frameworks
Conduct a systematic assessment to identify applicable regulatory frameworks based on product type assessment, geographic analysis, data classification, development phase mapping, and risk-based classification for comprehensive regulatory coverage for your life sciences workloads. Repeat this process as the project and its requirements evolve over time.
Desired outcome: A comprehensive regulatory framework map that clearly identifies applicable regulations, their specific requirements, and how they impact different aspects of your life sciences project. This enables informed decision-making and verifies that you don't overlook regulatory requirements.
Common anti-patterns:
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You assume a one-size-fits-all approach to auditing without accounting for specific regional or other requirements.
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You identify applicable regulatory frameworks as a one-time activity and assume adherence even as the project evolves.
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You assume the applicable regulatory frameworks have been identified without regular review to verify.
Benefits of establishing this best practice:
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Provides clear guidance for project stakeholders on regulatory expectations.
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Identifies required regulatory submissions and approvals.
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Reduces risk of becoming non-compliant over time.
Level of risk exposed if this best practice is not established: High
Implementation guidance
GxP refers to the regulations and guidelines applicable to life
sciences organizations that make food and medical products such as
drugs, medical devices, and medical software applications.
Depending on the location of research and development, governing
bodies may include U.S. Food & Drug Administration
(FDA
Review regulations related to your project location and industry. Consider what type of data you will be handling in your application, where it is collected, and where it is stored. Consider if there are data sovereignty or residency requirements that would determine the Region in which data can be stored or processed.
Implementation steps
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Identify relevant regulatory frameworks based on the type of project and how data is managed, collected, and stored.
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Document the frameworks that apply to your project and region. Review the resources available from AWS Compliance Programs
to find AWS resources for common regulatory frameworks. -
Identify requirements that are common across frameworks to identify necessary checks to satisfy applicable controls.
Resources
Related documents:
Related tools:
