What about IQ, OQ, or PQ?
A new chapter of computerised system assurance — driven by agile, risk-based digital quality — is opening to replace old-school, burdensome, and paper-heavy system validation. Current FDA Computer Software Assurance (CSA) and GAMP guidance also recognises that the qualifications fail to align with the iterative and agile nature of contemporary software development.
Likewise, Seal is shifting away from this linear documentation approach, to focus on the foundations of GAMP:
Prove the system is fit for intended use
Ensure the system meets compliance baseline standards
Manage any risk relating to patients and product quality
Seal's validation process addresses aspects of IQ, OQ, and PQ.
Platform validation -> Seal demonstrates that the system is fit for purpose through our robust software development lifecycle process by mapping requirements to functions, and conducting appropriate testing.
Configuration Validation -> Seal works with customers to ensure that your configured Seal platform is fit for your intended purpose. While we may not know every specific workflow, our goal is to provide the foundation for success: to enable and empower customers to effectively execute their workflows by providing robust technical support and tools.
Compliance validation -> Seal partners alongside customers to ensures that the Seal Platform meets all applicable rules, guidelines, and standards.
The table below summarises tests that are performed - note that this is not a comprehensive list.
Platform Validation
Validating the installation and accessibility of platform components
Testing the platform’s operational readiness and basic platform operations
Demonstrating that the platform performs as expected under baseline-like conditions
Configuration validation
Validating organisation-specific settings are applied consistently
Verifying functionality of configured workflows and integrations, and testing functionality these
Verifying that the configured system supports organisational use cases, including configurations for edge-case scenarios
Compliance Validation
Verifying that the software installation meets predefined regulatory requirements
Validating critical compliance-related functionalities (such as audit trails, user authentication) perform as required
Verifying that organisational workflows and data are compliant to regulatory standards, and continue to maintain compliance during user and system interactions
How should I explain Seal's validation process to a potential auditor?
There are several actionable items which are required from your end. These are documentation, revolving around:
Last updated