What Is Included in the Validation Package?
The package supplied by Inflectra normally includes the following documents for the requested Spira version:
1. Validation Certificate
A formal certificate identifying the applicable Spira product version and confirming that the release was developed and tested in accordance with Inflectra’s internal software development and quality assurance processes.
2. Requirements Traceability Matrix
The internal requirements traceability matrix for the release. This document maps the requirements included in the release to the test cases used to verify them, providing evidence that the documented functionality was covered by testing.
3. Test Plan
The internal test plan used by Inflectra for the release. The test plan documents the scope and organization of the testing performed as part of the release process.
4. Test Results
The recorded results of the tests executed against the release, including the outcome of the applicable test cases.
Together, these materials provide customers with supporting evidence that can be incorporated into their own validation records, supplier assessments, and regulated quality processes.
Confidentiality and NDA Requirements
The supporting documentation contains confidential information about Inflectra’s internal product requirements, test procedures, and quality assurance processes. Consequently, Inflectra can provide the validation package only after an appropriate Non-Disclosure Agreement (NDA) has been executed between Inflectra and the requesting organization.
If your organization already has a current NDA in place with Inflectra, please include that information when submitting the request. Inflectra will confirm that the agreement is applicable before releasing the documentation.
When no NDA is currently in place, Inflectra will provide the necessary agreement for review and signature before processing the request.
How to Request the Documentation
To request a Spira Validation Certificate and supporting validation package:
- Contact Inflectra Customer Support or your Inflectra account representative.
- Provide your organization’s name and the Spira product and version for which documentation is required.
- Identify the person who should receive the package.
- Confirm whether your organization already has an NDA in place with Inflectra.
- Complete the NDA process when required.
Once the NDA has been verified, Inflectra will review the request and securely provide the available documentation for the specified release.
Validation packages are version-specific. Customers should therefore confirm the exact version of Spira deployed in their environment before submitting a request.
Important Scope of the Validation Package
The documentation supplied by Inflectra relates to the development and internal testing of the standard Spira product release identified in the certificate. It is intended to support, but not replace, the customer’s own validation activities.
Each customer remains responsible for determining the validation requirements applicable to its organization, intended use, regulatory obligations, configuration, integrations, customizations, infrastructure, and operating procedures.
The Inflectra validation package does not certify or validate:
- The customer’s individual Spira instance or hosting environment (if on-premise)
- Customer-specific configurations, workflows, custom properties, reports, or templates
- Third-party integrations or SpiraApps
- Custom-developed extensions or modifications
- Customer data, procedures, or business processes
- The suitability of Spira for a particular regulated use without a customer-specific assessment
Customers should use a risk-based validation approach to confirm that their configured Spira environment is suitable for its intended use.
Additional Validation Capabilities in Spira
Spira provides integrated requirements management, test case management, test execution, defect tracking, reporting, and requirements-to-test traceability. These capabilities can help regulated organizations create and maintain their own validation records within a controlled, auditable system.
For example, customers can use Spira to document user and functional requirements, link requirements to verification tests, organize validation test sets, record execution results, track deviations and defects, and generate traceability reports. Spira’s integrated traceability capabilities make it possible to connect requirements with the tests used to verify them and analyze the impact of failed tests on important requirements.
Summary
Inflectra can provide eligible customers with a version-specific Spira Validation Certificate, requirements traceability matrix, test plan, and test results. Because these materials contain confidential internal information, a signed NDA must be in place before they can be released.
To begin the process, contact Inflectra Customer Support or your account representative with your organization’s details and the exact Spira version for which the documentation is required.