LSOPS03-BP03 Establish clear definitions of responsibilities between you, vendors, and users
A shared responsibility model to clearly delineate responsibilities between involved parties makes it straightforward to work together.
Desired outcome: Have a structure and expectations in a tool to streamline audits.
Level of risk exposed if this best practice is not established: Medium
Implementation guidance
Select prepared frameworks when applicable to apply industry standards.
Implementation steps
-
Review the AWS Shared Responsibility Model
to identify your areas of responsibility. -
Access AWS Artifact
for audit reports and documentation. -
Deploy AWS Audit Manager framework to create assessment frameworks aligned with specific life sciences regulations like FDA, EMA, and ICH-GCP requirements.
Resources
Related tools:
