Change Management

Ensuring compliance, traceability and risk control in laboratory operations

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:

Change Sets

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

Arcade

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

Step 1: Change Request Submission 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.