For pharma, biotech and contract manufacturers
GMP qualification that runs on day one
Not after the implementation project, but after onboarding. Paperless qualification and validation per Annex 15, Annex 11 and 21 CFR Part 11, with templates in which the tests for your equipment are already written. For companies with 10 to 1,000 employees that must deliver the same evidence as a corporation, without its validation department.
What you may expect from a validation platform
Everything a GMP inspection presupposes is standard
Paperless, traceable, audit-proof. That is the baseline, and it is included in every licence.
- Life cycle per Annex 15 URS, DQ, IQ, OQ, PQ as a continuous chain with traceability, requalification with interval and trigger, change control with impact assessment.
- Electronic signatures per Part 11 and Annex 11 Signature meaning, second factor at signing, role-based approval workflows, four-eyes principle enforced by the system.
- Audit trail per ALCOA+ Who, what, when, why, immutable and exportable, with review notes per Annex 11 §9.
- Reports inspectors can read Qualification and validation reports as PDF/A with signature pages, reproducible identically from the same data.
- Status in real time Every plan, every test item, every deviation with status and owner, without an Excel list on the side.
- Operated in Germany Dedicated instance per customer with its own database, two-factor login, data processing agreement per GDPR.
What QV NOW does differently
Beyond the baseline: content you would otherwise have to create yourself
Other platforms deliver an empty shell that you or an implementation partner fill with tests, criteria and workflows over months. QV NOW brings that with it.
The tests are already in the plan
For sterilisers, WFI systems, freeze dryers, isolators, filling, blister lines, HPLC and more, IQ and OQ tests with parameters, acceptance criteria and references to standards are ready. You remove and add instead of starting from zero.
Ready in hours, not months
Onboarding together with us: users, sites, equipment, instruments, approval workflows. Then the first qualification runs. No implementation partner, no project plan spanning quarters.
A measurement only counts with the right instrument
Parameter, unit, measuring range and valid calibration are checked at entry. An instrument that does not fit cannot be selected. A value outside the limits raises the deviation immediately.
Statistics built in, not in Excel on the side
Cpk and Ppk in process validation, MSA studies per AIAG, sampling locations and sample volumes per ISO 14644-1 calculated from the standard. Traceable in the report, not in a spreadsheet without a version.
Risk-based per ICH Q9, justified in the plan
Validation approach pharma, medtech or hybrid per plan with justification. Risk priority drives test scope and sampling. The inspector reads the justification in the plan, not in an e-mail.
AI assistant with source reference
Upload the manual, specification or URS as PDF and receive test proposals with criterion, expected result and source location in the document. Only what a person confirms is adopted. Can be disabled per tenant.
Fixed price from three licences
€1,347 per month for three users, operation and updates included. One-time onboarding, depending on project status. No time-and-materials billing, no multi-year minimum term, no partner network in between.
Support from Q&V engineers
Questions are answered by Q&V engineers, an auditor and a production expert from medical devices and pharma. On request we accompany your first qualification and give your inspector read access.
Templates for pharmaceutical equipment
The qualification plan exists before you write the first test
Every template brings the IQ and OQ tests of the equipment type with parameters, acceptance criteria and references to standards. You adapt what differs at your site.
Sterilisation and pure media
- Steam steriliser (autoclave)
- Hot-air steriliser
- H2O2 plasma steriliser
- Clean steam generator
- WFI water system
Manufacturing and filling
- Isolator and RABS, aseptic
- Vial and syringe filling
- Freeze dryer (lyophiliser)
- Tablet press and capsule filler
- Coater and fluid bed
- Mixer and homogeniser
- Bioreactor, TFF and chromatography
Packaging and environment
- Blister line
- Glass primary packaging
- Labelling, printing, inspection
- Cleanroom monitoring per ISO 14644
- Particle counter
- Climatic chamber per ICH
Laboratory and analytics
- HPLC system
- GC-MS for residual solvents
- TOC and conductivity analyser
- Karl Fischer titrator
- UV/Vis and FTIR
- Endotoxin reader (LAL)
- Analytical balance, pH meter
Excerpt. The templates reference EU GMP Annex 15 and Annex 11, 21 CFR Part 11, ICH Q9, Ph. Eur. and USP, ISO 14644 and ISO 8573.
Validations
From cleaning to shelf life in one system
Cleaning validation
Worst-case selection, acceptance limits, sampling locations and analytics in one plan. Repeats and requalification from the plan.
Sterilisation load
Load patterns, temperature and pressure profiles, biological indicators. Readings from the data logger instead of a slip of paper, assessed against the acceptance window at entry.
Process validation
Product, process and equipment linked. OQ and PQ validation with Cpk and Ppk as acceptance criteria, process windows with limits, deviation raised automatically from the measurement.
Packaging and seal
Sealing process and packaging validation with a sampling plan per test condition, peel force and leak tightness as measurands.
Shelf life per ICH Q1
Stability studies with climatic chamber, test points and evaluation per ICH Q1E, in the same system as the equipment they run in.
Computerised systems
MES, LIMS, controls and monitoring software per Annex 11 and GAMP 5: pick the category, adopt the standard test catalogue, the traceability matrix builds itself as you work. CSV in detail
Bring your URS or an old qualification plan
In 30 minutes we show QV NOW on your equipment: from the pre-filled plan through the signature to the report your inspector receives.
Book a demo