Use the Tetra GxP Package to reduce your validation cost and time
Efforts to comply with GxP regulations and guidelines are often seen as significant but not value-adding activities. While you cannot buy GxP compliance, there are means to significantly reduce the burden.
First of all, we highly recommend leveraging the Computer Software Assurance (CSA) approach to improve efficiency and lower costs. With updated risk guidance, your system should be substantially derisked, and the assessment activities can be scaled down correspondingly.
The Tetra GxP Package is designed to hew closely to best practices and guidance on CSA, streamline your validation process, and provide substantial savings in time and effort. The GxP Package is an annual subscription executed as part of the annual subscription license agreement. Details about the package can be found in our GxP solution brief and V&V strategy document.
With the Tetra GxP Package, you receive (for every major/minor release):
- Platform requirements and traceability
- Platform validation scripts
- Platform V&V summary report
- File-Log Agent requirements and traceability
- File-Log Agent validation scripts
- File-Log Agent V&V summary report
- Empower Agent requirements and traceability
- Empower Agent validation scripts
- Empower Agent V&V summary report
…and more as we add our industrialized integrations to the Tetra GxP Package.
We estimate an 80% decrease in time and cost to perform GxP system initial validation, change control, and recurring annual upgrades/revalidations. This represents a 2-3x ROI for your investment.
The GxP package supports your validation efforts with:
- Platform updates: When a major or minor update to the platform is released, you will receive updated validation documentation and release notes that describe the changes. This includes updated requirements for new functionality, executed validation scripts for new and existing functionality, and a summary report of the verification testing performed pre-release, including the GxP assessment of the new release. To complete your change management activities, your validation team has to determine what new requirements are met by the update, revise the requirements specification and validation scripts, update traceability, and so on. These time-consuming tasks are already performed by TetraScience and are part of the GxP Package, allowing customers to avoid duplicating these non-value-adding activities.
- Agents and connectors: As we add more industrialized integrations to the Tetra GxP Package, its value rises correspondingly. With our completed documentation set, including the documentation of requirements, validation scripts, and traceability, customers don’t have to perform the related validation from scratch. We estimate a 2-3x ROI for new validations.
- Agent and connector updates: Just like platform updates, modifications to agents and connectors lead to a proportional increase in change control effort. To mitigate this, customers can use our GxP package.
- Time delay: Teams can avoid time-consuming assurance activities and documentation as well as delays in value realization from the updates.
- Support: As part of the Tetra GxP Package, you receive support for do-it-yourself (DIY) validation efforts, even if they don’t align with our actual validation strategy or evidence.
- Supplier assessment: The Tetra GxP Package includes the opportunity to perform a live supplier assessment audit for up to two days free of charge.
The adoption of the Tetra GxP Package will accelerate your transition to industry best practices of CSA. It will significantly reduce your total validation cost, speed up value realization, and ensure your continued success leveraging the Tetra Scientific Data and AI Cloud™ in your validated workflows.
To learn more, read the GxP solution brief.