FAQ: Validify Services
1. What do software validation services typically include?
A full engagement covers three core deliverables: a documented risk assessment, a complete set of validationdocuments (validation plan, requirements, test protocols, and summary reports),and an impact assessment for each covered platform release, with ongoing annualplans supporting up to six updates per year. Validify delivers this as a hybrid approach that combines hands-on regulatory expertise with an automatedplatform, so documentation is generated and maintained continuously rather than rebuilt from scratch each cycle.
2. Which platforms can be covered under an ongoing validation service?
Any GxP-relevant cloud platform,with clinical systems being the most common: EDC, eCOA, RTSM, and e-consent solutions. Because these vendors push several releases a year, each system receives an updated impact assessment and refreshed validation documents after every change, helping organizations maintain documented validation evidence and ongoing compliance throughout the year.
3. How is continuous validation different from a one-time validation project?
A one-time project validates a snapshot of your system, and that validation package begins to age as soon as the vendor releases the next update. Continuous validation treats each release as a trigger: changes are assessed, risks are re-evaluated, and documentation is updated, typically covering up to six platform updates per year. Thepractical difference shows up during an audit, when your documents reflect the system as it runs today, not as it ran eighteen months ago.
4. Does outsourcing software validation keep us audit-ready?
Yes, when the service is structured around ongoing assurance rather than a single deliverable. Audit readiness means being able to show current risk assessments, traceable validation documents, and evidence that every platform change was evaluated. An outsourced continuous validation service maintains exactly that trail, with outpulling your QA and IT teams away from their core work.
5. How much do software validation services cost?
Pricing at Validify is per system and depends on scope. For a single release, a risk assessment starts at $2,500 and validation document creation at $5,000. Annual continuous validation, which covers ongoing releases throughout the year, starts at $6,000 for risk assessment and $8,000 for validation documents, with discounts available when multiple systems are covered. Compared to the consultant-day model, where a full manual cycle for one platform routinely runs into tens of thousands of dollars, the annual cost is typically lower than a single traditional validation run.
6. Can we validate software in-house instead of using an external service?
You can, and regulatory responsibility always stays with you either way.The real question is capacity: mManually validating even one cloud platform through its yearly release cycle can consume significant QA and IT effort throughout the year. Outsourcing makes sense when your team manages multiple systems, when vendor updates keep arriving faster than you can assess them, or when validation expertise is not something you want to build and retain internally.
