[ Next Generation AI-Powered Validation ]

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GxP Compliance Automation Tools & Intelligent Validation at Scale

With GoVal AI, validation teams can reduce manual effort, improve traceability, and gain actionable insights across the entire lifecycle. Our GxP compliance automation tools leverage AI-driven validation automation to streamline Computerized System Validation (CSV) processes. From URS and functional specifications to final execution and reporting, every step is optimized for speed, consistency, and compliance. The result is a streamlined, audit-ready process that helps pharma and other life sciences organizations meet regulatory requirements with confidence.

What GoVal AI can do for you?

Validate URS & Specifications

Take a help from GoVal AI to validate URS, functional and design specifications

AI-Driven Risk Assessment

Automatically categorize GxP risk levels using machine learning models trained on thousands of validation projects, supporting risk-based validation approach methodologies for life sciences validation

Test Case Management

Generate comprehensive test protocols instantly based on system requirements and historical project data.

Intelligent Insights

GoVal AI empowers you to query validation records and deliver an analytical edge to your validation process.

SaaS Based AI Platform

Our SaaS validation platform life sciences solution integrates seamlessly with existing GAMP 5 validation software frameworks, enabling digital transformation validation across pharmaceutical validation software ecosystems.

Enterprise Grade Compliance

Benefit from around-the-clock enterprise support, automatic version upgrades, and secure cloud hosting—ensuring your validation projects always run on the most up-to-date, fully compliant platform.

Unlock Insights with Validation Data Analytics

Move beyond static documents and leverage the full power of your validation data. GoVal AI acts as your intelligent analytics engine, allowing you to ask complex questions in plain language and receive instant, actionable insights. Read our post on revolutionizing validation with AI to learn more.

  • Natural Language Queries: Simply ask "Which projects were completed in the last 30 days?" or "List the count of projects by validation status for each location" to get immediate answers.
  • Real-Time Reporting: Generate dynamic summaries, graphs, and reports from user inputs without manual data compilation.
  • Trend Analysis: Identify bottlenecks, track cycle times, and monitor compliance trends across all your validation projects to make informed, data-driven decisions.
GoVal AI Analytics Dashboard showing prompt-driven reporting for validation data.

Ready to Accelerate Your Validation?

Experience the power of AI in your validation workflows and achieve compliance faster than ever.

Book a Demo

Frequently Asked Questions (FAQ's) about GoVal AI

Which large language models (LLMs) does GoVal AI use?

GoVal AI is model-agnostic. We integrate with leading LLM APIs—including OpenAI (GPT-4/4o), Google Gemini, and Azure OpenAI (the same model family used by Microsoft Copilot). Customers can bring their own API keys, pin regions for data residency, and enforce no-training-on-customer-data by default. We can also add a customer-preferred provider on request.

Can we restrict GoVal AI to a single LLM vendor?

Yes. You can lock usage to one provider (e.g., Azure OpenAI only) and disable others per policy.

Does GoVal AI support on-prem or private cloud models?

Yes. We support models for private or on-prem deployments when data cannot leave your network.

How does GoVal choose which model to use?

We route by task (reasoning vs. extraction), document size, latency/cost targets, and your vendor policy.

Is customer data used to train models?

No. By default, prompts and outputs are not used to train third-party models. BYO credentials and provider settings are honored.

Where is our data processed and stored?

You can pin regions (e.g., EU/US) at the provider level. All records, e-signatures, and audit trails remain in the VLMS.

How does GoVal align with 21 CFR Part 11 and EU Annex 11?

GoVal provides electronic records & signatures, role-based access, versioning, and complete audit trails to help meet Part 11/Annex 11 expectations.

Can we get a full audit trail of every AI action?

Yes. Inputs, outputs, versions, and approver actions are logged and available for reporting.

What documents can GoVal AI read?

URS, FS/DS, SOPs, protocols (IQ/OQ/PQ), deviations/CAPA, supplier docs, and prior reports—common formats include PDF, DOCX, XLSX, and CSV.

Can GoVal AI generate test cases from URS/FS/DS?

Yes. It proposes risk-based, scenario-driven tests and highlights gaps or redundant steps.

How does GoVal reduce hallucinations?

We use retrieval-augmented generation (RAG) from approved documents, constraining AI output to governed templates for accuracy.

Does GoVal AI support multiple languages?

Yes. Specifications can be multilingual while UI language depends on deployment settings.

How does GoVal support the transition from CSV to CSA?

We emphasize intended use and risk, enabling adaptive testing and producing appropriately sized documentation with full traceability.

Do AI outputs require human approval?

Yes. Approval gates and e-signatures enforce mandatory review of AI-generated steps or tags before use.

Will GoVal AI assist with periodic reviews?

Yes. The system flags impacted items, suggests minimal re-validation, and schedules reminders for reviews.

Can GoVal AI integrate with Jira, ServiceNow, or SharePoint?

Yes. Integrations cover ticketing, content sources, and evidence storage. Custom connectors are also available.

What happens if a LLM provider is down or rate-limited?

We failover to approved backups per policy, respecting data residency requirements.