Configuration Validation

Custom Validation in Seal is a comprehensive process that aims to ensure successful assessment of the software's functionality according to your customised configurations. The scope of work described below is not an exhaustive list of validation activities performed - the Seal Team will also scope and take into account any additional testing.

We do the bulk of the work - from your end, you just need to specify your requirements.

1

Assessing Customer Requirements and Specifications

Customer needs and requirements are identified via the sales cycle and implementation. Customers are required to specify any specific regulatory requirements they are under, any validation requirements from their internal quality processes.

Where necessary, Seal may ask for additional documentation to better understand the technical requirements that are needed.

2

Risk Assessment

Seal uses a systematic process to identify, evaluate, and mitigate risks associated with a system, process, or product to ensure it meets predefined standards of quality and safety. This process is critical to validate that systems and processes perform as intended without posing risks to users or consumers.

The customer is responsible for their regulatory compliance activities and their business processes. Seal is designed to support the common elements of all quality management processes generally and has the flexibility to support specifics as necessary at the customer level. As the customer partners with Seal, they are responsible for the other risks involved, such as managing Seal as a supplier.

3

Validation Master Plan

The Validation Master Plan aims to outline the timelines and to guarantee complete validation of the Seal Platform, aligning with relevant regulations and protocols.

This Validation Master Plan outlines the validation scope, a risk-focused approach, necessary resources, quality assurance tasks, and deliverables involved. Customers typically own the creation and drafting of the validation master plan based on their own templates and requirements, but Seal has the flexibility to support the review of the Validation Master Plan as necessary.

4

Qualification and Testing

The qualification process involves verification of several elements, such as (but not limited to):

• Test environment Set Up

• Unit Testing

• Integration Testing

• System Testing

• User Permission Levels

• Or any other test that the customer provides to test specific parameters.

Additionally, customers may conduct User Acceptance Tests (UAT) to confirm the ability of users to execute basic functions. In some instances, the platform will be tested by a core set of users, and feedback from these “beta” users enables specific changes to be made to optimise the customer’s workflows. This stage ensures that the functional design and configurations in Seal aligns with the customer’s specifications and is compliant to their current workflows.

5

Validation Report

The Validation Report aims to assess the Seal Platform with specified requirements outlined in the Validation Plan, and accuracy and reliability of the software in performing its intended functions within the customer, and its performance under various operating conditions and environments.

Seal typically uses Validation Report templates provided by the customers. If necessary, the team can provide support in drafting a report, as necessary.