Straight answers for regulated teams.

Software for GxP labs that validates and maintains regulated equipment and controls quality documents. It has three modules. Validate drafts, reviews, executes and closes equipment qualification. Maintain runs PM, calibration and work orders. Control runs your quality manual, policies, SOPs, work instructions and forms as controlled documents.

Quality, validation and facilities teams in biotech and other GxP labs, and the validation consultancies that support them.

They share one equipment inventory. A unit qualified in Validate is maintained in Maintain, and the quality system around it lives in Control, with nothing entered twice.

The user requirements specification, risk assessment, IOQ protocol and SOP, then the executed IOQ, its exceptional conditions and the final summary report, compiled into one signed record.

12 GxP equipment families with validation templates, from biosafety cabinets and centrifuges to cryogenic storage and transport systems, plus weighing devices and liquid handling equipment for calibration.

Yes. A consultancy can run each client as its own organization and move between them from one sign-in.

Write and approve the URS from the equipment's intended use. If you already own the equipment, you can start from its manual instead and review the specifications ValDoc reads from it. Then draft the risk assessment, IOQ and SOP, review and approve them, execute the IOQ against each unit, resolve any exceptional conditions, and close with the final summary report.

Yes. Write and approve the URS from what the equipment must do first. When the equipment arrives, ValDoc compares its specifications with the requirements, and you sign the Procurement Assessment.

Yes. Declare the jurisdictions a URS is written for, the United States, the European Union or both, and each requirement cites the provisions it traces to. The citations print in the document and its PDF.

The failure raises an exceptional condition, which goes through its own review, correction and approval before the execution can close.

The executed IOQ with every signature, exceptional condition and attachment, and the final summary report with the qualification decision, compiled into one PDF.

There are three roles: Quality, Validation and Facilities, and one person can hold more than one. Validation runs executions, Facilities completes maintenance and closes work orders, and Quality or Validation approves validation records. Administrators run the account.

Segregation of duties. The author cannot be one of its approvers, and ValDoc says so on the control itself: “You wrote it, so another reviewer has to approve it.”

Every document and execution in review names a Quality owner, a Quality person who did not work on it, and it cannot be finalized without their approval.

It reads manuals into specification values, drafts validation documents, proposes the category of an exceptional condition and drafts the description of a change.

It never approves, signs or executes anything. Every suggestion shows where it came from, and nothing enters the record until a person accepts it.

Yes. Each value read from a manual links to the page it came from, and a specialist accepts or dismisses it.

ValDoc is built for Part 11 and EU GMP Annex 11 use: password-verified electronic signatures with their meaning and signing role, attributable actions and a full audit trail. Whether your use is compliant also depends on your configuration, procedures and training.

Yes. It records who did what, to which record, and when, and every member can read it. Filter it, and export it for an inspector.

A finalized revision cannot change, and its content hash would show if it did. An approval given before the content changed is flagged, and every earlier revision stays on file.

Control runs your controlled documents. Your procedures, training program, supplier qualification and risk decisions remain yours.

By module and by the size of your program: how much equipment you validate, how many people work in ValDoc, and the scope of your rollout. A demo is the fastest way to a number.

Import them into Control, from Word or PDF. ValDoc copies the text exactly and proposes each document's ID, title and class.

Rollouts usually start with one equipment family, run it from the first draft to the signed record, and widen from there.