FAQ

Valkit.ai is a paperless Digital Validation Tool (DVT) with automation and AI-driven functionality designed to streamline GxP validation processes in the life sciences industry. It uses contextual AI to enhance compliance, efficiency, and accuracy.

Yes, we allow integrations at the organizational level with various systems including Jira, DevOps, and custom LLM APIs. These integrations help streamline your validation workflows and enhance productivity.

The Lion represents a modern take on the Scottish heraldic symbol 'the Lion Rampant', as a nod to our founders collective heritage, and as a reflection of our 'fearless first' corporate attitude. The rainbow color represents the spectrum of CQV activities that our platform facilitates and celebrates the diversity of thought, experience and background that our team members and customers bring to the platform everyday.

Yes, Valkit.ai supports all traditional validation disciplines, including CSA (Computer Software Assurance).

Valkit.ai is specifically built for the life sciences industry, focusing on GxP validation processes for pharmaceuticals, biotechnology, clinical studies, and medical devices.

Valkit.ai ensures that all customer data is securely isolated in dedicated instances. • Customer data is never used to train our LLM. • We do not share customer data with external parties. • More details about our responsible AI policies and data privacy can be found on our website.

Our contextual AI is designed to understand and apply GxP guidelines, ensuring all processes meet industry regulations. Our electronic signatures are compliant with 21 CFR Part 11 and EU Annex 11.

Valkit.ai offers full, partial, or no AI augmentation for your paperless validation processes. When activated, several contextual RAG AI models analyze documents, enhance compliance checks, and provide intelligent support—all while keeping human oversight intact.

Yes, we offer personalized demos to showcase how Valkit.ai can revolutionize your GxP processes. Contact us to schedule a demo tailored to your needs.

Signed-in customers can access detailed guides in the in-app Help documentation. For general product questions, see the FAQ and product pages on valkit.ai, or contact support.

We offer flexible pricing plans tailored to the needs of your organization. Please contact our sales team at [email protected] for more details.

Due to our frictionless, cloud‑based approach, most customers are up and validating in less than a week with no implementation fees.

Absolutely. Our AI models are customized to align with your documentation and processes, ensuring accuracy for your unique GxP environment.

According to ISPE GAMP® 5, Valkit.ai is classified as an Infrastructure tool (Category 1), meaning it can be qualified as a supplier without a discrete system validation. However, we offer a full end‑to‑end Validation Package with each validated release to support your qualification process.

Our customer success team is trained in migration strategies to help you transition rapidly and compliantly from legacy platforms.

We work with a partner network of validation consultants who provide competitive pricing and best practices for your specific projects.

Valkit.ai holds an individual ISO27001 certification. In addition, our infrastructure and services meet minimum ISO27001 requirements.

Our platform is hosted in 19 global Amazon regions and supports translation in 10 languages—including English UK/US, Spanish, German, French, Chinese, Japanese, Portuguese, and Korean. Customers can request more languages as needed.

Our Help Center and customer support team are ready to assist you. Detailed documentation is also available for step‑by‑step guidance.