Product Development Lifecycle

This page is a summary of the Seal product development lifecycle. The product development and support phases are guided by the following requirements from GAMP Supplier Good Practices (but are not limited to):

• Documented set of procedures and standards

• Well-defined requirements from regulated companies before onboarding

• Quality planning

• Design review process

• Defined standards for software production

• Clear user documentation and training

A summary of the process is listed below.

1

Scope

The objective of this stage is to scope issues and requirements, based on following criteria (but not limited to):

1. Description of requirement, including user stories, user flows, and edge cases

2. Source of requirement

3. Level of priority

4. Additional comments regarding analysis, possible solutions, problems, and queries

This comprehensive approach ensures structured documentation to allow clear, concise scoping plans.

2

Specify

This converts the scoping conducted above into actionable items to address the issue or requirement. This includes (but not limited to):

• Review and clarification meetings to define specifications

• Developing designs based on requirements, with design iterations if necessary

• Creation of issues for approved designs

This involves collaborative wok between the development, design, and product delivery teams.

3

Develop

GitHub serves as Seal's designated task system for creating, tracking, and managing work tasks. This centralised platform proves advantageous for software teams in GxP environments due to features, including version control with auditing capabilities, change tracking and documentation, automated testing and continuous integration tools, and efficient issue tracking.

Per Appendix D4 of GAMP 5 on the Management of Software, the following requirements for each software task ensure clear traceability and are all available in GitHub:

1. Reference/traceability to associated design artefacts

2. Descriptions of the task

3. Timestamps

4. Summary of changes

5. User account making changes

The timeframe for issues are based on the priority assigned to the requirement.

4

Testing

A rigorous multi-phase testing process is conducted before any new feature or update is introduced to ensure the platform maintains the highest standards of quality, performance, and reliability for users.

Production changes undergo the following stringent approaches prior to release. These include both automated (comprising database and end-to-end tests) and manual testing methodologies:

1. Module testing (unit and database testing)

2. Acceptance testing (utilising playwright tests)

3. Peer reviews

A crucial aspect is the integration of Continuous Integration, where automated checks are performed with each commit. This ensures immediate notification to the developer in case of errors, maintaining a proactive approach to identifying and addressing issues during the development lifecycle. Additionally, if applicable, additional tests are written for changes introduced by the new features to test for any specific interactions and flows that are affected by the new changes.

For all changes, it is mandatory that:

• All pull requests must pass automated tests

• All pull requests require the completion of a peer review and approval

5

Release

Release would entail passing of all requests, complete QA checks, successful validation of the platform.

Feature descriptions are documented on in the Seal Changelog.

Executed platform tests documented in the 'Validation' tab in your Seal platform.

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