Seal is committed to ensuring compliance to the most current approach to software validation, broadly recognized in the Life Sciences industry. Seal generates and executes the test elements that demonstrate the system is meeting the requirements set for it to function as an electronic quality systems management tool as a standard, integrated part of the product development process.
The Validation Process in Seal is a comprehensive process that results in complete validation of the system, aligning with relevant regulations and protocols. The process aims to ensure successful assessment of the software's functionality. As Seal is a SaaS application, validation of the system is a partnership between Seal and the customer. In order for a complete validation of the system to occur, the customer must partner with Seal to manage the overall system.
The scope of work described below is not an exhaustive list of validation activities performed by the Seal team.
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.
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.
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.
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.
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.
