Greenlight Guru Software Validation Guidance
Updated Jun 1, 2023
While Greenlight Guru provides validation information to all customers, it is the customer’s responsibility to understand what is required in order to demonstrate compliance during an audit. As the Greenlight Guru software platform is critical software used within the quality management system, this guidance provides additional information to customers regarding internal Greenlight Guru validation, testing practices, and what is required for review.
Note: Greenlight Guru validation is related to its software system only. Greenlight Guru does not maintain or validate hardware as the platform is cloud-based and not hardware specific.
Responsibility Matrix - Provided by Greenlight Guru
Installation Qualification (IQ)
Customers are required to execute and document the Greenlight Guru provided IQ protocol to demonstrate verification of operating systems, browsers, network connections, and display resolution. To maintain IQ records, Customers shall upload their completed IQ report into their Greenlight Guru application as a record within Document Management.
If a company has multiple locations, they may choose to have a representative at each location complete the IQ protocol. If a company is remote and there are many different devices and networks being used, they may include a statement similar to the following:
All employees at [Company] using the Greenlight Guru Software have the same or equivalent Operating System, Browser, Network Connection and Display Resolution. Since each user was able to accept their invitation to Greenlight Guru and access the platform in order to create their account, this proves Greenlight Guru can be accessed by all users.
Greenlight Guru recommends that customers re-run the IQ every 2 years or upon major network change. Customers will determine and establish the validation cadence on their Master Validation Plan.
For each Product Update, customers are notified of the update and the Validation Package is updated. The Greenlight Guru Validation Package has been created to reflect Computer Software Assurance and ISO/TR 80002-2:2017 requirements and best practices.
Within the Validation Test Report document, the intended use statements based on the specific features, functions, and operations for the workspaces are included. The Test Cases column shows the traceability of the intended use statements to the Validation Test Summaries. The description of the automated testing within each Test Case can be found in Appendix B of the document.
Customers are required to have objective evidence documenting their review of the Greenlight Guru Validation Test Report. During this review, a customer shall review the intended use statements provided by Greenlight Guru to ensure the stated intended use is reflective of the customer’s use of the Greenlight Guru software. The customer shall document their review by uploading the latest Validation Test Report into their own Greenlight Guru environment. The report shall be routed for approval per the customer’s Document Control procedure. If the customer is using Greenlight Guru not as intended by Greenlight Guru, the customer is responsible for additional validation.
For each subsequent Product Update, customers shall review the Validation Test Report by repeating the upload and review process for the new document version. In the event that intended uses are updated as a result of a Maintenance Release, customers shall be notified of the need to upload and review the new Validation Test Report. See Greenlight Guru’s definitions of release types below.
The Development Process
Greenlight Guru deploys three types of releases: Product Updates, Maintenance Releases, and Patch Releases. Greenlight Guru administrators can find the current software version number in “My System” under Organization Settings.
Product Updates are releases that contain new and/or significantly changed functionality. Examples include adding a new workspace, significantly changing the way you interact with a workspace, features, or architectural elements.
- Product Updates are scheduled throughout the calendar year.
- They are versioned as [Year of Release].[Major Version].0, where [Major Version] increments with each product release during the year, resetting to 1 in the next year. An example is 2023.4.0.
- They require verification (Internal Quality Testing) as well as automated testing. Results of automated testing shall be made available to Customers with each Product Update.
Greenlight Guru Product and Engineering teams follow Product Development Lifecycle and Software Development Lifecycle processes to determine functionality additions and changes in each Product Update, and to document requirements for those changes and for related non-customer-facing architecture and infrastructure changes. These requirements are broken down into documented work tasks that describe development and testing activities necessary to bring the changes to fruition and ensure that they function properly and that they have not disrupted functionality elsewhere in the application.
Maintenance Releases are a mix of preventive and corrective software updates (e. g. defect fixes), incidental changes, and moderate feature updates. Examples include fixes to an error state, restoring functionality to an intended state, changes to UI, or adding data exports. Moderate feature updates may supplement existing functionality.
- Maintenance Releases are deployed as needed, typically weekly.
- They are versioned as [Year of Release].[Major Version].[Minor Version], where [Minor Version] increments with each Maintenance release, resetting to 1 at the next [Major Version]. An example Maintenance Release version is 2023.2.5.
- They require verification (Internal Quality Testing) and a risk assessment. Greenlight Guru provides Customers with a memo documenting the release’s contents and a risk statement for each item.
As maintenance releases do not require full automated testing to be performed, the Validation Package from the most recent product update shall apply to the maintenance release unless noted otherwise. For example, for maintenance release 2023.2.4, the Validation Package from 2023.2.0 shall apply.
Patch releases are considered to be routine maintenance and are limited to changes to Greenlight Guru infrastructure and platform environments, including third-party dependencies. These releases do not increment any customer-facing version numbers and neither validation nor customer notification is required.
Should you require any additional clarification regarding the process deployed at Greenlight Guru regarding Software Validation, please contact us with any additional questions.