Software for qualification and validation
Qualification and validation that knows what the auditor will ask
Plans built from proven templates. Measurements that only count with suitable equipment. Reports that hold up in an audit. Ready in a few hours, hosted in Germany.
Your starting point
What do you make? Choose your field
Each page shows QV NOW with the equipment, evidence and regulations that matter in your field. Built for companies that must deliver evidence without launching an IT project.
Medical devices and IVD
Qualify equipment, validate processes, prove every result to your Notified Body or the FDA. You are in the right place. This page is written for you, just keep scrolling.
Continue on this pagePharma and biotech
Qualification per Annex 15, data integrity per Annex 11 and Part 11, templates for sterilisers, WFI, isolators, filling and laboratory. Ready in hours, not after an implementation project.
For pharma and biotechMachine and plant building
Your customer demands URS reconciliation, FAT and SAT protocols and a traceability matrix. QV NOW produces documents your customer adopts into their IQ, OQ and PQ.
For machine and plant buildersWhat is included
One system for all qualification and validation evidence
The modules interlock: the instrument in calibration management is the same one that releases the measurement in the OQ.
- Cleanroom qualifiedISO 14644-1, compressed air ISO 8573-1More ›
- Equipment qualifiedDQ, IQ, OQ, PQMore ›
- Instruments suitableCalibration status, measurement system analysisMore ›
- Staff qualifiedTraining record checked before executionMore ›
- Approval by e-signatureFour-eyes principleMore ›
- Washing process validatedCleaning validationMore ›
- Sterilisation validatedSterilisation validationMore ›
- Packaging validatedSealing processMore ›
- Transport validatedTransport validationMore ›
- Software validatedCSV per GAMP 5More ›
Plus: deviations, CAPA and change control, 12 report types with audit trail, AI assistant for test proposals.
Four steps from equipment to signed report
Instead of leaving you alone with blank templates, QV NOW guides you through a fixed sequence.
The plan exists before you start
Create the equipment, pick a template, done: the IQ and OQ tests for your equipment type are in the plan with parameters and acceptance criteria. You remove what does not apply and add what makes your equipment special.
- Templates for medical devices, injection moulding and machinery, sterilisation, pharma, laboratory and cleanroom
- Every template versioned, every use traceable in the plan
- AI assistant reads the manual or specification and proposes tests with source reference
Four eyes, enforced by the system
Submit, review, approve: role-based, with electronic signature and signature meaning per 21 CFR Part 11. Whoever submits cannot approve. The system does not allow it, regardless of who happens to have time.
- Approval workflows that match your QMS, per record type
- Signature with password, authenticator or passkey
- Approved plans are locked, every change goes through change control
A measurement only counts if the instrument fits
Right parameter, right unit, a measuring range that fully covers the acceptance window, and a valid calibration. An instrument that does not meet this cannot be selected. A value outside the limits automatically raises a deviation.
- Data entry on a tablet right at the equipment
- Import measurements from the machine, CSV or Q-DAS instead of retyping
- Calibration status of all instruments at a glance, reminders before due date
Reports that hold up in an audit
The result is a PDF/A report with signature page that can be reproduced identically at any time from the same data. Every requirement leads to its test, every test to its result.
- 12 report types, from qualification plan to traceability matrix
- Complete audit trail per ALCOA+, review notes per Annex 11
- Your logo and your document numbers, not ours
Pricing
Fixed monthly licence instead of a project price
No time-and-materials billing, no multi-year minimum term, no partner network in between. You know what QV NOW costs before the first conversation.
All prices and ROI calculatorQV NOW licence
- Base: equipment qualification and process validation, templates per equipment type extra
- Dedicated instance in Germany, updates included
- Additional users tiered, from €149 per user and month
- One-time onboarding €4,041*, then ready to use in 2 to 4 hours
All prices plus VAT. * Onboarding depending on the customer's project status.
See in 30 minutes what your next qualification looks like
We show QV NOW on your equipment type, not on a demo example.
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