General
What if I don't need GxP compliance?
What if I don't need GxP compliance?
If your system doesn’t have a direct GxP impact (for example, it’s used for early-stage R&D), you don’t need to follow the formal Configuration & Compliance Validation process. Instead, you can rely on the much simpler process of User Acceptance Testing (UAT) to confirm the system is fit for your purpose.
How long does validation take?
How long does validation take?
Seal has automated a large portion of the validation process, making this quick and easy - no more waiting for weeks and months! There is also little work from the customer end.Speak to our Seal Team for a better gauge of timeframe.
When should I validate my system prior to use?
When should I validate my system prior to use?
This would largely depend on your implementation timelines, and when you want to start using various modules in Seal.In our experience, we recommend validating when implementation is fully completed, with everything built and set up.We, however, have customers that prefer validation in phases.
How do you ensure that validation is compliant with regulatory standards?
How do you ensure that validation is compliant with regulatory standards?
Let the Seal team know which regulatory standards you need to be compliant to.Our Seal experts will be able to ensure the correct compliance validation is carried out.
Will Seal provide support if I would like to conduct validation myself?
Will Seal provide support if I would like to conduct validation myself?
Yes, we do provide support if you prefer to conduct validation yourself. Seal’s documentation can be re-purposed to fit your QMS.
Revalidation
If Seal performs tests on the platform, does that mean I don’t need to validate the system myself?
If Seal performs tests on the platform, does that mean I don’t need to validate the system myself?
Seal provides baseline validation testing for all our customers. You could perform a repeat of these functionality tests, although we tend to not recommend this as this would be a repeat of validation work.The additional testing required would be due to specific system configurations that are built into Seal, to fit your organisational workflows. Speak to our team to find out how we can help with this process.
How often do I need to revalidate?
How often do I need to revalidate?
You will need to re-validate when any changes have been made within your platform.Not to worry, Seal makes this easy as we have productised automatic system re-validation into our platform. It is largely automated - re-validate your platform with just a click of a button!
Do I need to revalidate if I add new templates and make changes to workflows?
Do I need to revalidate if I add new templates and make changes to workflows?
Whilst one would need to validate the template (or changes made), we’ve made this process incredibly easy within our system, productising much of the work!You will also have access to our Seal’s Team for any technical or general support.
Do I need to revalidate my system if my organisation moves to a new site?
Do I need to revalidate my system if my organisation moves to a new site?
As there would be no change in the physical server locations, databases, or in the core system architecture upon moving, this should not be needed.Our Customer Success team can support you in the creation of any risk assessments required.
Documentation
Does Seal provide validation templates and reports?
Does Seal provide validation templates and reports?
Absolutely. We provide a comprehensive validation package, including templates for your URS and Risk Assessment, our own platform validation documentation, and a configurable Validation Summary Report that you can generate on-demand.
Does Seal provide User Acceptance Tests?
Does Seal provide User Acceptance Tests?
Yes, we do. We provide a set of baseline User Acceptance Tests (UATs) that you can use as a starting point for testing your specific configuration.
Can I download a Validation Report?
Can I download a Validation Report?
Yes, you can. Once you have completed your validation activities, you can generate and download a comprehensive Validation Summary Report directly from the Seal platform.
Misc
How do I view the current Seal version number?
How do I view the current Seal version number?
The current version number can be seen within the Settings page in the Seal Platform.
Do I have to validate features that are not enabled within my Seal platform?
Do I have to validate features that are not enabled within my Seal platform?
In short - no.If they are not enabled within your Seal platform, they have been turned “off”, and your platform will not have any interaction with this feature.
How does my API tie in with validation?
How does my API tie in with validation?
The API will enable data flow within Seal but does not change the behaviour of the Seal Platform. It is on the customer to document the set-up and configuration of the API, including the risk assessment aspects.The API itself, is tested within routine Seal testing.