Stay validated — validation management as a subscription

You take out a monthly subscription per site or group of systems. You can join after the baseline assessment, once critical gaps are closed or covered by an approved action plan. We set the frequency per client based on risk. Package activities are a guideline; we finalise them in the quote.

Monitor

• Periodic reviews
• Audit-trail sampling
• Change-impact assessments, up to an agreed number per quarter
• Quarterly report

Assure

• Higher-intensity reviews and sampling
• Keep documentation current
• Quarterly report with a review meeting and an inspection-readiness check

Inspection-ready

Everything in Assure, plus trend analysis and one or more mock inspections, so you go into the inspection well prepared.

Validation of new systems and major upgrades is offered as a separate project. QA release and IT operations remain with your organisation; support is during office hours. The fee depends on the number of systems, their risk class, the package and the frequency; you receive a tailored quote. The minimum term is 12 months, with three months’ notice after that.

Request a system inventory