Software validation, also referred to as software qualification or software verification, is the process of checking that a software system meets specifications and that it fulfills its intended purpose.
Some industries, primarily regulated industries like pharma and life science, require systems (both hardware and software) to be qualified before they are commissioned into production. The idea behind those regulations is simple: ensure the validity of your tools before you give it your trust, and reputation.
Deployment model for validation
At AlisQI, we strive to keep surprising our customers with the functionality and performance of our quality management system. This requires continuous development. We extend, improve, and optimize our software all the time. We release updates to the application (almost) daily.
While this continuous improvement is highly appreciated by our customers, it can present challenges for some of them in terms of software qualification or validation.
For the customers conforming to a formal software upgrade policy, we offer an alternative deployment model: AlisQI Validate.
In this article
AlisQI Validate
The AlisQI Validate deployment model enables user organizations to validate and accept new releases before they are deployed to production. This allows for formal Computer System Validation or internal software qualification routines.
In this Validate deployment model we offer three parallel AlisQI environments:
- Production
The actual production environment. This environment will not receive continuous updates and is updated only every 3 months. Every AlisQI Validate version is identified with a unique identifier that is static for its entire lifespan. - Validation
Environment for user acceptance testing. This will be updated to the next AlisQI Validate release one month before updating production. - Current
A test environment that will receive all updates. This can be considered the continuously updated preview of the next AlisQI Validate release.
Critical (security) patches will be deployed, but only if they pass all our internal qualifications.
Critical (security) patches will be deployed to Production, but only if they pass all our internal qualifications.
All three environments have their API connectivity, in order to validate system integrations.
While API connectivity is fully enabled, outgoing webhook calls are disabled in the Validate and Current environments.
In this Validate model, the Production environment will only be updated every three months. A month before the update, the Validation environment will be updated with the upcoming release. This enables the user organization to go through their validation scripts and complete the validation. As the Current environment is always updated, this is very useful to preview upcoming functionality.
Schematically
Release scheme
- Validation will be updated on the first Monday of every new quarter.
- Production will be updated on the first Monday of the second month of the quarter.
- Current will be updated daily. This version is in sync with the version deployed to the non-Validate tenants.
Responsibilities
The table below documents the responsibilities in the operation of the Validate process.
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Activity |
AlisQI |
Customer |
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Execution of the automated test suite |
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Deployment of validation environment |
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Development of validation script |
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Execution of validation |
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Bug fixes after validation |
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Documentation of changes to software |
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Documentation of (changes to) configuration |
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Deployment of new release to production |
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Data migration after deployment of new release to production |
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IQ / OQ / PQ activities
In FDA and GMP context system validation is often defined with three acronyms: IQ, OQ and PQ. We will briefly discuss them and how we have implemented these principles in our operations.
Installation Qualification
The Installation Qualification protocol verifies the proper installation and configuration of the system. The routine of instantiating a new AlisQI tenant on our hosting platform is fully automated.
Operational Qualification
The Operational Qualification activity includes the assertions to be run in order to verify that the software is operationally fit to be deployed to the customers and meets all its requirements. As discussed in the section on software delivery in this document, we only deploy software after it has passed all tests in our automated test suite. You can find the documentation on the AlisQI Validate releases here.
Performance Qualification
After IQ and OQ, the final step in the qualification trinity is the performance qualification (PQ). This is to verify that the system consistently performs to the specifications for its day to day (routine) use under real world conditions. This activity is led by a user organization.
In our software design process, we incorporate performance in the design evaluations and technical assessment to ensure that the software is fit for use in production context.