The Validation Process

How is my system validated?

During implementation, your system will have already been validated covering the following 3 areas:

Baseline Validation

In Seal, automated, baseline validation tests are essential checks are performed daily to ensure the functionality, stability, and reliability of the Seal Platform. These automated tests ensure that it consistently operates as intended and maintains validated status across its life cycle, and must be passed anytime there are any changes made.

A full list of all tests can be found in the Validation tab in the bottom left of your Seal platform screen.

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.

Compliance Validation

Compliance validation is a critical process where regulatory oversight, industry standards, and legal requirements dictate how software must operate. This type of validation ensures that the software platform meets all applicable rules, guidelines, and standards.

Seal is built for regulated industries - compliance requirements are integrated into the software’s design and architecture.

From your end, you just need to specify which regulatory standards you need to be compliant.

Our Seal experts will then be able to ensure the correct compliance validation is carried out.

Automatic Revalidation

In Seal, the system undergoes Automated System Validation, after changes are made. This ensures that any change made to the system is re-validated.

Automated System Validation leverages on Change Control. It is integrated into the Seal platform software using Change Sets - no changes can be made until a Change Set has been performed and approved, ensuring that any change in Seal has no impact on other functionality of the overall system.

Learn more about Change Control and Change Sets here.

How do Change Controls tie in with re-validation?

In GxP companies, Change Control is a structured process used to manage, document, and implement changes in a controlled and systematic manner - this ensures that any modifications have been evaluated for their potential impact on quality and compliance.

Changes to the Seal Platform can disrupt critical functionalities and alter system behaviour. Change control ensures that:

• What is changed in Seal has no impact on other functionality of the system
• To document evidence of tests to show that system functionality is still the same

Having change control built into the Seal Platform ensures that any modifications to the system are documented, reviewed, and have been re-validated - ensuring your platform is consistently at a validated state.

How do I know if my system is compliant to a standard?

Seal’s compliant co-pilot is a streamlined and efficient way to verify that your configured Seal Platform meets compliance standards. This process allows users to self-validate system functionalities through predefined automated tests to ensure workflows are functional and compliant.

This automated approach helps ensure ongoing quality and regulatory readiness as your QMS evolves. Below is a guide for conducting compliance validation. Note that this guide does not serve as legal counsel for achieving absolute compliance for auditory purposes.

1. Create a Saved View

In the search page, create a saved view of all relevant entities.

2. Run Neil, the compliance AI Copilot

To open our Copilot, click on the ‘AI Co-Pilot’ tab on the right hand side.

• Enter the following prompt into the chat:

Can you read all my files in this Saved View and check if I am <regulatory standard> compliant? Generate a report on any missing or recommended processes.

It might be helpful to give the Co-pilot some extra context or information about your organisation, processes, and necessary workflows. If you already have pre-existing Procedures or Documentation, Neil will be able to use this information when validating.

3. Executing Validation

Neil will scan through your organisation and check if your system is missing any necessary documentation or procedures for your regulatory compliance.

4. Make Changes, and Perform re-Validation if needed

Based on the results, Neil may give advice on missing documentation or configured workflows. After making the necessary changes, you will be able to perform re-Validation to check and ensure you have correct documentation and properly configured workflows.

Need help? Email our team at [e-mail].

What is needed my end for validation?

We do the bulk of the work - from your end, we require:

1. Define any specific configurations needed

What specific configurations are needed within your organisation?

2. Define necessary regulatory compliance

Which international standards do you need your system to be compliant to?

3. Define other requirements needed, from your internal QMS

Are there SOPs within your QMS that defines your organisation’s validation processes?

4. Leave it with us

Our experts will ensure that Seal is implemented, functional, and meets the performance needs while adhering to regulatory requirements - fully validated.

Using Change Sets to achieve compliance

Effective change management is essential for maintaining compliance, ensuring process integrity, and mitigating risks in laboratory operations. This document outlines the structured approach used to assess, approve, and implement changes within our organization. By adhering to a formalized process, we ensure that all modifications to workflows, systems, and documentation are properly evaluated for regulatory impact, risk, and operational efficiency. This framework supports ISO compliance by providing traceability, accountability, and a clear approval pathway for all changes affecting our lab processes.

Integrated within the Seal platform is a change management system using Change Sets, Review Requirements and Checks.

Seal provides an integrated blueprint process that can be adapted to a customers needs, including the relevant documentation to be completed and the associated review flows:

Go To Interactive Video

The blueprint can be found at:

https://seal.run/blueprints/change-management

Built within the change set blueprint provided by Seal are the following:

Step 1: A Change Request form

Initiated by the relevant stakeholders who identify a need for change. The request is documented in the Seal eQMS using a dedicated change request form, which captures key information such as the change description, justification, impact, and affected (linked) documents or processes.

View template here: https://seal.run/blueprints/change-request-form

Step 2: Change Evaluation & Risk Assessment

Once submitted, the change request is assessed for potential impact on product quality, safety, compliance, and operational efficiency. The Seal eQMS supports this evaluation by allowing stakeholders to link relevant risk assessments and documentation, ensuring that all potential risks are identified and addressed before proceeding.

View template here: https://seal.run/blueprints/change-evaluation

Step 3: Approval Process

The request moves through a structured approval workflow, where relevant stakeholders (e.g., Quality, Regulatory, System Owner, Management) review and approve or reject the change.

This process is managed within Seal, allowing for automated notifications, tracking, and approval routing. Approval can be completed using electronic signatures, ensuring compliance with ISO 13485 and other regulatory standards.

Step 4: Implementation & Verification

Once the change is approved, the implementation phase begins. The Seal eQMS tracks the execution of the change, ensuring that the correct procedures and timelines are followed. If necessary, testing and validation activities are documented and tracked within Seal, ensuring that the change does not adversely impact system performance or compliance.

Step 5: Post-Implementation Review & Documentation

After the change is implemented, a verification process confirms the successful execution of the change. All related documents, including updated SOPs or work instructions, are linked and stored within Seal, ensuring that the documentation is up to date and accessible.

Step 6: Audit Trail & Continuous Improvement

All stages of the change process are recorded in Seal’s audit logs, providing traceability and accountability. The system also allows for periodic reviews of the change management process, enabling the organisation to identify trends and areas for improvement.

Learn more about the audit trail here.

Can I download a Validation Report?

This validation report is applied to an unconfigured Seal Platform. This does not serve as legal counsel as a validation report for a customised platform.

In order for a complete validation of a customer system to occur, the customer must partner with the Seal Team to manage and testing any configuration they deem necessary, based on their intended use and associated risk.

For more information or to export this for your documentation, please reach out to our team at [e-mail].

This Validation Plan aims to outline validation of the a basic, unconfigured Seal platform. This page outlines the validation scope, a risk-focused approach, necessary resources, and quality assurance tasks. Following this will achieve the outcome that Seal consistently operates as intended and maintains validated status across its life cycle, for an unconfigured platform.

1. Introduction and Context

Seal is an electronic platform. The tool is web based and multi-tenant, accessible on any device capable of supporting a web browser. Seal uses SaaS industry standard SDLC methodology and Agile software development.

While Seal is configurable to meet customer needs for quality system management, Seal does not do custom code or customise of features at the software code level for customers. All configuration is set in the individual customer instances.

Seal has an open API and is capable of pushing/pulling data to/from other software tools through integrations. In the case that a customer desires an integration to another tool, it is the customer’s responsibility to define and document that interface, as well as test that the interface produces the desired behavior in Seal. Seal supports these activities as necessary, but ultimately Seal’s functionality is designed for these activities and the behavior of the system is the same whether the data is input through integration or the standard user interface.

Seal is not directly responsible for the Patient Safety, Product Quality, or Data Integrity (specifically meaning systems that generate/control product quality or release data). In the case of data integrity specifically, the standard elements of access control, security, user management, privilege management, data backup and retention are already covered through the Risk Assessment.

2. Regulatory References

The use of Seal is subject to regulations prescribed by American and European regulatory agencies.

Seal is designed to support the common elements of all quality management processes generally considered by the Life Sciences industry and ISO 9001 (the basis for all quality management systems and ICH), and has the flexibility to support specifics as necessary at the customer level.

The customer is responsible for their individual regulatory compliance activities and their business process definitions/risk management.

3. Software Functionality Verification

Please refer to the Software Functionality Verification section below.

Software Functionality Verification

The testing process encompasses a comprehensive range of functionalities, ensuring thorough assessment across all critical areas of the software.

Verification of Critical Functions and Features

• Aligning with user needs - A clear understanding of the software requirements is gathered through various means, such as analysis of functional specifications, user stories gathered through onsite visits and calls, and documentation from the customer.

  The software’s configuration and functionality is closely aligned with the needs and requirements of its intended user base.

• Test Environment Set up - The Seal platform will be configured to mimic the customer’s environment. Test cases have been conducted to cover inputs, outputs, and paths through templates and tables.

• **Unit Testing - **Unit testing involves testing individual units or components of the software in isolation.

• Integration Testing - Integration testing focuses on verifying that the individual units or components work together as expected. This involves testing the interactions between different functions to ensure they integrate seamlessly and produce the desired outcomes.

• System Testing - System testing involves testing the software functions in the context of the entire application, including user interfaces, databases, and other system components.

• Compliance with Specification - The software’s functionality aligns with the predetermined specifications and user expectations, demonstrating its capability to perform its intended functions accurately and reliably.

4. Recommended Operating System for Optimal Use

Opvia can be used across various operating systems such as Windows and MacOS.

Google Chrome is the recommended browser as it is the platform used to design and test Opvia. It is recommended that users upgrade to the latest version of Google Chrome for optimal performance.

5. Continuous Improvement Opportunities

Ongoing monitoring and evaluation are recommended to address any emerging issues and ensure sustained performance. Identified weaknesses or areas for improvement should be addressed through an internal feedback system, such as the incorporation of periodic user feedback or monthly calls with Skye Biologics’ Upper management.

6. Conclusion

Based on the conducted tests and analysis, it has been confirmed that the software successfully meets the specified functional requirements. The validation outcomes underscore the successful assessment of the software’s functionality, reaffirming its suitability for its intended purpose in Skye Biologics. Users can have confidence in the software’s ability to perform as expected, contributing to Skye Biologics’ objectives and user satisfaction.