Own the validation function, not just the projects.
Periodic review programme, change-control response, revalidation, RTM stewardship and audit readiness — as a service.
Validation managed services cover the lifecycle obligations that have no project attached to them — periodic review at a defined cadence, change control assessment, supplier reassessment and revalidation execution. This is where validated estates quietly decay, because getting a system validated has a budget and a finish line and keeping it validated does not.
Outcomes you can expect
- Periodic review SLA
- Change response SLA
- Continuous audit readiness
Validation Managed Services is delivered by our managed services practice. Where it saves time, the team uses our products: GxP Copilot for validation lifecycle work and TraceDraft for clinical documentation.
Explore related capabilities: Clinical Managed Services, Regulatory Managed Services, AI Managed Services,
Validation as a Managed Service: Continuous Assurance over Project Execution
Computer system validation in life sciences has historically been delivered as a project — a discrete engagement producing a validation package at a point in time. This model produces a system that is validated at release and then drifts out of validated state as the system changes, the regulatory environment evolves, and periodic reviews fall overdue. Validation managed services replace the project model with a continuous assurance model in which the validated state of your computerised systems is actively maintained.
Cybroscape's Validation Managed Services programme provides ongoing validation governance, change control support, periodic review execution, RTM stewardship, and audit readiness maintenance for your GxP-regulated computerised system portfolio. Service delivery is governed by a defined SLA: periodic review notifications issued 90 days before due date; change control impact assessments completed within five business days of change request submission; mock audit conducted annually with findings report issued within ten business days.
Periodic Review, Change Control, and RTM Stewardship
Periodic review is the mechanism by which validated systems are systematically re-evaluated to confirm that validation remains current. Without a managed periodic review programme, reviews are missed or completed without adequate depth — a consistent finding in FDA 483 observations. Under our managed services, we issue review notifications, scope the review against current system configuration, execute the review with a qualified validation engineer, and produce a review report within the defined SLA. Every overdue review is flagged and escalated before the due date, not after.
Change control validation impact assessments are completed within five business days for standard changes and fifteen business days for complex changes. The Requirements Traceability Matrix is updated in parallel with every change control event — the RTM accurately reflects the current validated state at all times. Annual RTM audits verify that every URS requirement is covered by a current test case and that every test case maps to a current requirement. RTM gaps are resolved through the change control process before the next periodic review.
See it on your own system.
Bring a URS or a system. We show you the validation package it produces.
- We reply within one business day
- We run your URS live on the call
- You get a clear plan and scope