FAQ

Questions Regulated Teams Ask First

Straight answers about ValDoc.AI, validation document generation, digital execution, AI data use, compliance support, pricing, and rollout.
Answers by Topic

What Teams Should Know

A practical first-pass guide for validation, quality, and operations teams evaluating ValDoc.
Platform

Platform Basics

What ValDoc is, who it serves, and where it fits.

ValDoc.AI is a GMP-focused validation platform for generating, reviewing, approving, executing, and compiling validation records. It helps teams replace fragmented authoring, review, execution, and closeout work with a more controlled validation workflow.

ValDoc is built for quality, validation, engineering, and operations teams working in regulated life sciences environments. It is especially useful for teams managing repeated validation work across equipment portfolios, sites, and review groups.

ValDoc currently focuses on user requirements, risk assessments, IOQ protocols, SOPs, execution records, exceptional conditions, signatures, supporting evidence, and compiled validation records.

Equipment qualification is the current center of gravity, but ValDoc is designed around the broader need for controlled validation records, governed review, execution visibility, and traceable closeout.

Workflow

From Draft to Closeout

How records move from draft to approval, execution, and closeout.

Teams bring their validation context into ValDoc, generate controlled drafts, review and approve records, execute approved work, resolve exceptional conditions when needed, and compile the final record.

Yes. AI drafts; Subject Matter Experts (SMEs) review, edit, approve, and execute. Generated content is treated as draft material until your team has reviewed it through the controlled workflow.

An approved IOQ can move into digital execution. Teams can complete execution activities, capture required signatures and evidence, track status, and submit the executed record for review.

When execution results require follow-up, ValDoc keeps exceptional conditions connected to the validation record and supports a governed path from documentation through review and closeout.

AI & Data

AI, Data, and SME Review

How AI is used, reviewed, and kept separate from model training.

ValDoc uses AI to accelerate drafting and extraction work for validation teams. The goal is to reduce manual authoring effort while keeping review, approval, and execution decisions under SME review and approval.

AI supports parts of the drafting and extraction experience, but important compliance decisions stay under SME review and approval. Your team decides what is accepted, edited, approved, executed, and finalized.

No. Customer equipment specs, documents, validation records, and workflow data are not used to train AI models. Your validation data stays scoped to your organization.

ValDoc is built for controlled validation workflows rather than open-ended chatbot-style output. AI-assisted drafts are reviewed by SMEs before they become approved or executed records.

Compliance & Trust

Compliance Support

How ValDoc supports governed work without replacing your quality system.

ValDoc is designed to support Part 11 workflows, including controlled records, attributable actions, signatures where implemented, and audit history. Whether a system is compliant depends on intended use, configuration, procedures, training, and the customer's quality system.

Yes. ValDoc tracks governed actions across the validation workflow so teams can understand who did what, when it happened, and which record was affected.

ValDoc is built to help teams maintain traceable validation records with controlled revisions, approvals, execution history, exceptional conditions, signatures, supporting evidence, and compiled outputs.

No. ValDoc supports validation record workflows, but it does not replace your quality system, procedures, training program, supplier qualification, or internal risk-based decisions.

Pricing & Rollout

Pricing and Rollout

How teams evaluate, scope, and start using ValDoc.

ValDoc uses demo-led, sales-assisted pricing because validation scope varies by equipment portfolio, team size, rollout needs, and support expectations. Every plan is centered on the core validation workflow rather than a maze of add-on modules.

Yes. The best way to evaluate ValDoc is to walk through your workflow with our team and see how generation, review, approval, execution, and closeout fit your validation process.

Implementation depends on scope, source materials, team structure, and governance requirements. Early rollouts usually focus on a defined equipment family or validation workflow before expanding across a larger portfolio.

ValDoc is built around a structured validation workflow, and rollout discussions can cover how your procedures, approval expectations, equipment families, and execution practices fit the platform.

Want to See How ValDoc Fits Your Workflow?

Walk through your validation process with our team and see how ValDoc connects generation, review, execution, and closeout.