About us
We built QV NOW because we searched for it ourselves for years
Evidence for equipment and processes is complicated and laborious. We make it simple. Our vision: every company can do qualification and validation itself with QV NOW.
Uwe Philippeit
Auditor for medical devices, DGQ trainer and lecturer at the Karlsruhe Institute of Technology. Over 20 years of quality management and regulatory affairs in medical devices and pharma, on both sides of the audit table.
“In audits I have seen the same gaps hundreds of times: missing calibration records, acceptance criteria without a source, approvals by the wrong person. Each of these gaps is a rule in QV NOW that the system enforces.”
Stefan Koopmann
Expert in operational excellence and ramp-up in medical devices and pharma. For over 20 years he has supported contract manufacturers and legal manufacturers with process validation, production ramp-up and supplier qualification.
“What you can measure, you can control. QV NOW makes sure every measurement counts: with the right instrument, against the right criterion, with a deviation when necessary.”
How we think
Translating standards into testable templates
Regulation has five levels: international harmonisation, law, regulation, standards and guidance, and at the very bottom your company's QMS. The levels above are the same for everyone. The work happens at the bottom: what exactly does ISO 14644-1 require for your cleanroom? Which IQ tests follow for your steriliser?
Exactly this translation is built into QV NOW: templates in which the requirements of the standards appear as concrete tests with acceptance criteria. You do not start with a blank page but with the state of the art.
Built in Karlsruhe
EvidencebyUS GmbH, founded 2026. Development, operation and support in Germany.
Validated per GAMP 5
QV NOW is developed along the same V-model it enables for its customers: requirements, specification, tests, approvals.
Network
Active in the DGQ, Medical Mountains and teaching at KIT. We know the questions that come up in audits because we ask them ourselves.