SciNote’s Quality Assurance Services
Trusted by the FDA, NIH and European Commission, SciNote offers Installation qualification (IQ), operational qualification (OQ), process validation and more!
Understanding SciNote’s QA services
SciNote’s IQ – Installation Qualification
Installation qualification’s purpose is to verify the SciNote installation was done correctly.
Execution if your organization is using the cloud version:
- Verification is executed by SciNote, and a signed report is sent to your organization.
Execution if your organization is using the locally installed version:
- If your organization installs SciNote locally, the verification is executed by your organization, IQ will be provided to your organization (the IQ protocol should not be altered, only executed)
SciNote’s OQ – Operational Qualification
Operational qualification’s purpose is to verify that the SciNote application is performing as expected.
Execution if your organization is using the cloud version, or the the locally installed version:
- Verification is executed by your organization, SciNote provides the template which can be expanded with your custom scenarios.
Dedicated separate validation instance
This additional validation instance allows the SciNote team to perform the IQ and your organization to execute the OQ, before deploying a new update of SciNote on the actual production instance.
Controlled software updates and releases
Upon request, the regular SciNote updates can be performed in a non-automatic manner, to meet the QA needs of the organization.
Timeline of QA Services execution
- IQ – Installation Qualification:
Performed right after the installation, before the handover to your organization.
- OQ – Operational Qualification
Performed after the SciNote instance is set up, before your organization starts using the instance.
There is no such thing as an out of the box compliant software, it is always used in the context of the processes within your organization.
Electronic lab notebooks need to be validated in the context of your processes. However, a tool can go a very long way to help you and your QA team to save a lot of effort when you do need to go through the validation process.
Choose your Scinote plan
SciNote Platinum Plan includes QA services for your lab