Start with reusable tests
Inspect the steps and expected results before adapting the documents.
Less document preparation. More progress.
How can we spend less time building validation documents?
Give your team a structured starting point, so they can focus on demonstrating that your manufacturing system works for your process.
From your requirements to a reviewable draft
- Your URSIntended use and site requirements
- Included libraryReusable tests and function descriptions
- Draft packageIQ, OQ, PQ and requirement links
- Your quality systemReview, complete, approve and execute
See coverage and gaps
Bring unanswered requirements into the review instead of hiding them in a finished-looking package.
Keep approval with your team
Work with editable documents under your existing document-control process.
Your validation project should start with your process, not a blank page.
Before the first test is executed, your team has requirements to organize, protocols to prepare and coverage to establish. Recreating those documents leaves less time to examine how the system will actually be used. IntelliTrack™ provides a version-specific foundation that your team can inspect and complete.
How it works in IntelliTrack™
From requirements to a package your team can work with.
Find your foundation
Search the Document Library, inspect reusable tests and the Coverage Register, and download editable Word documents. This library workflow needs no AI connection.
Connect your requirements
Supply a readable PDF or Word URS to the AI-assisted Package Generator. AI selects relevant library tests; IntelliTrack™ checks the selections and assembles draft protocols, a traceability matrix and an optional FRS.
Move forward with clarity
Review selected tests, gaps, open items and any requirements not assessed. Complete site-specific details, then approve and execute the documents under your own quality system.
Illustrative manufacturing scenario
Documents with a purpose. A team with a plan.
For an assembly line introducing electronic production records, the team can start with requirements for installation, recipe controls, traceability and access. The useful outcome is a package whose proposed coverage can be examined before execution begins.
Installation qualification (IQ)
What you can inspectInstallation tests and the applicable release information.
Your team's decisionComplete the checks and evidence for your actual environment.
Operational qualification (OQ)
What you can inspectSelected operational and integration tests.
Your team's decisionReview whether the tests cover how your team will use the system.
Performance qualification (PQ)
What you can inspectProposed scenarios for the intended production use.
Your team's decisionSet up representative products, conditions and acceptance criteria.
Requirements traceability
What you can inspectLinks between requirements and the selected tests, plus gaps and open items.
Your team's decisionResolve missing or unassessed coverage before approving the package.
Optional functional specification (FRS)
What you can inspectLibrary function descriptions assembled into a draft.
Your team's decisionReview the functional scope against the intended installation.
Your quality system. Your team's judgment.
- The library is included with IntelliTrack™ and available to Engineering and Administrator users. Confirm the software version and applicable library baseline for your project.
- The Package Generator requires a configured AI provider connection assigned to its workload. Review what the URS contains and your organization's permission to send it to that provider.
- Generated documents are drafts. They do not execute tests, mark results as passed or establish compliance. Your team reviews, completes, approves and executes them, records evidence and resolves deviations.
Practical questions
What to know before you start.
Do we need AI to use the Document Library?
No. You can search, preview and download reusable tests and inspect the Coverage Register without an AI provider. Only the AI-assisted Package Generator requires a configured provider connection.
Is the validation library included?
Yes. The documented workflow needs no separate validation feature entitlement. The included library is tied to the IntelliTrack™ release; FDS can also issue signed library updates. Check the applicable baseline and coverage when planning your project.
Can we edit the documents to fit our installation?
Yes. Tests are available as editable Word documents, and generated packages are downloaded for review and completion outside IntelliTrack™. Your document-control process governs the approved versions and execution records.
What happens when a requirement has no matching test?
The package exposes coverage gaps and open items for review. Requirements an AI provider could not assess are identified as not assessed. Your team determines which additional tests, evidence or responsibilities are needed.
What does the generator do with our URS?
It reads the submitted PDF or Word document and uses the configured provider to select library tests. IntelliTrack™ assembles the documents and offers a temporary download. Retain the approved output in your own document-control system; this workflow is not a long-term repository for your validation project.
Does the generated package validate our installation?
No. It prepares draft documentation. Validation still depends on your intended use, configuration, approved protocols, executed tests and reviewed evidence. A complete-looking document is not a passing test result.
Bring your requirements. See where your team can start.
Bring your URS, or an outline of the system you need. We can inspect relevant library coverage and walk through the package your team would review.