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.

Aspect	IQ	OQ	PQ
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:

• Acknowledging and qualifying Seal as a supplier, including evaluation of risk assessments

• Defining Seal's intended use within your organisational workflow

• How Seal is configured to a customer's organisational workflow

• How Seal manages the validation process, and the customer's role within this

• Reviewing of Seal's platform updates and its respective changelog