QM10 Core Software Releases and Related Documentation

For SOLABS QM10 Core Software, there are 2 types of Releases: 

• Minor/Major Release
• Corrective Release

❶ Minor Releases (such as 10.9.0 or 10.9.1) /Major Release (ex: 11.0.0 - Subject to discontinuation): This type of Release is delivered twice a year (minor) and includes a minimum of one item in each of the following categories:

New Features/Function

Feature - Logic Change

UI / UX

Security and Performance

Packaging & Delivery

Infrastructure

Cloud Offering

These types of Releases are aligned with the SOLABS Roadmap.

The Release Notes is the first document shared with clients for this type of Release. It is created as soon as the initial Change List (the items planned for the Release) is defined. Until the Release is final, the Release Notes should be treated as a guide only, since items may still be added to or removed from the Change List.

→ Release Notes will be available in the SOLABS’ Knowledge Base (refer to the following article for when and how the Release Notes are published: https://docs.solabs.com/hc/en-us/articles/6191548553879-SOLABS-Release-Notes-When-and-How-)

Each of the Minor/Major Releases is operationally qualified by SOLABS.  All the items included in the Release will be tested/qualified in accordance with an Operational Qualification Protocol. Every change included in a new minor/major release (all changes from the previous release) is qualified according to the impact assessment done for each of them. In addition, regression testing is performed to confirm that changes included in the release did not have an overall undesired impact on the system. 

→ The qualification documentation is provided in the SOLABS’ eRoom / Public folder (one folder per Release identified with the Release Number). This documentation will be provided once the qualification is completed.

The Qualification Documentation will always include the following (at a minimum):

• Validation Plan
• Operational Qualification Protocol
• Core Change List (FORM000011) – List of changes between the previous Minor/Major Release and the new Release
• Executed Test Scripts and related Documentation (such as Deviations)
• Operational Qualification Summary Report
• Core Software Functional Specifications
• Core Software Traceability Matrix

Minor/Major Releases may or may not include changes to the Document Control (P0007) and Audit (P0044) QM APPs.  If changes are required to these QM APPs, they will be included as part of a Minor/Major Release of the Core Software and the changes will be included within the Release Notes and within the Change List. However, each QM APP has its own qualification documentation.

→ The QM APP qualification documentation (equivalent to the Core qualification documentation) is also provided in the SOLABS’ eRoom / Public folder (one folder per QM APP / per release identified with the Release Number). This documentation will be provided once the qualification is completed.

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❷ Corrective Release (Ex: 10.11.0-1): This type of Release may be issued periodically, in between Minor/Major Releases, based on identified needs for punctual corrections.  These Corrective Releases may or may not be installed on clients’ instances, depending on their specific needs and availabilities. However, the corrections to a Release are ALWAYS included (will be part of the next minor or major change list) and qualified as part of the next Minor/Major release so will ultimately be installed with the next update.

The Corrective Releases do NOT have Release Notes.

→ Documentation will be provided in the SOLABS’ eRoom / Public folder (one folder per Corrective Release). This documentation will be provided once the qualification is completed.

The Documentation will always include the following:

• Executed Test Scripts
• Release Memo (that will include the list of changes)