Setting up your System

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.

1

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:

1. Document Metadata: Metadata fields, such as document title, author, and effective date are filled out accurately for each document

2. 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

3. Published Versions Ensure that documents are published and assigned a version.

Refer to Seal documentation on:

• How to upload files and documents

• Extracting metadata from files using AI

Missing a document? View our list of templates here.

2

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:

• Batch procedures

• How to setup review cycles

3

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:

How to add users, setup roles and permissions

4

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.

5

Checklist

Documentation:

• All required documents are uploaded, organised as appropriately

• (Optional) Version control and metadata are enabled for each document.

Procedures:

• Required workflows are set up and tested for proper functionality.

• Connections between workflows are set and verified.

• Reviewers and approvers are assigned to each workflow step.

User Roles and Permissions

• All users are added to the system with correct roles and permissions.

• Access levels are verified, and permissions align with user responsibilities.

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