Periodic review and continuous assurance
Worried your systems are drifting out of a validated state between projects? Keep your systems validated between projects. A recurring, CSA-aligned program maintains a documented state of control.
The challenges this solves
Periodic reviews keep slipping
Reviews are overdue because project work always takes priority.
Changes erode the validated state
Releases and configuration changes go in without consistent impact assessment.
Evidence is hard to produce on demand
Pulling together proof of control takes weeks when an auditor asks.
What we deliver
- Periodic review schedule and reports
- Change-control oversight and change-impact assessments
- Audit-trail review program
- Validation maintenance and updated documentation
- Drift and risk monitoring, with risk flags and remediation recommendations
- State-of-control summary reporting
- Inspection-ready evidence on request
4 steps, clear deliverables
- 01
Baseline
Establish the current validated state.
You receive: Validated-state baseline
- 02
Schedule
Set the periodic review cadence by risk.
You receive: Periodic review schedule
- 03
Review
Run reviews and assess changes.
You receive: Review reports and change-impact assessments
- 04
Report
Maintain inspection-ready evidence.
You receive: State-of-control summary report
Want to know what this would take for your systems? Start with a short scoping call.
Who we do this for
- Pharma & biopharma
- Biotech
- Medical devices
- Cell & gene therapy
- CROs & clinical
Related services
Questions we hear most
How often are systems reviewed?
The cadence is set by risk during the scheduling step. Higher-risk systems are reviewed more often.
Is this aligned with CSA?
Yes. Review effort is sized to risk, consistent with the FDA's CSA approach.
How is it priced?
As a recurring engagement with a fixed fee and defined scope, so costs are predictable.
Stay validated between projects
Get a scoped, fixed-fee quote for a recurring assurance program.