Setting up your System
Last updated
Last updated
This page provides guidance for ensuring the setup of Seal Platform is configured appropriately before conducting compliance validation. Note that this guide does not serve as legal counsel for achieving absolute compliance for auditory purposes.
Documentation Upload and Organisation
Ensure that all required documentation is uploaded into the Seal Platform. This includes all quality-related documents, such as SOPs, policies, work instructions, risk assessments, and relevant records.
Optional - ensure that uploaded documents have the following:
Document Metadata: Metadata fields, such as document title, author, and effective date are filled out accurately for each document
Relevant tags and/or in Saved views
Documents should be organised in a logical structure according to categories that match your organisation’s QMS framework. Common categories may include:
Document Control
CAPA (Corrective and Preventive Actions)
Audit Management
Risk Management
Nonconformance Reporting
Published Versions Ensure that documents are published and assigned a version.
Refer to Seal documentation on:
Missing a document? View our list of templates here.
Workflow Setup and Configuration
Procedures must be properly set up to ensure that workflows can be executed smoothly through necessary reviews and actions.
Configure workflows in the system and ensure that relevant connections are set-up, such as (but not limited to):
Document Review and Approval
Corrective and Preventive Actions (CAPA)
Change Control
Nonconformance Handling
For workflows requiring user approval and sign-off, assign relevant reviewers to each procedure, based on your QMS framework.
Refer to Seal documentation on:
User Setup and Role-Based Permissions
Ensure that all team members who will interact with the QMS are added to the Seal Platform, including administrators, reviewers, and view-only access users. Set up appropriate roles and permissions. Each user’s access level should align with their responsibilities within the QMS.
Setting up correct permission levels will ensure that users with the relevant roles can access the documents they need, and unauthorised access to sensitive documents will be restricted, to ensure compliance with privacy standards.
Refer to Seal documentation on:
Documentation of Setup and Pre-Validation Activities
Note that the Seal Platform has a built-in an audit trail that documents all actions and changes made in the system. In addition, Seal recommends customers to create a summary document to document all pre-validation activities to to confirm all elements are set up appropriately.
Checklist
Documentation:
Procedures:
User Roles and Permissions