NIS2 readiness
Readiness-focused assessment and roadmap that aligns operational controls and delivery priorities. This is positioned as readiness and gap assessment, not certification.
Compliance & Assurance
Risk-based compliance that keeps delivery moving.
We build risk-based compliance and assurance for quality-critical operations: validation evidence, operational controls, and security-ready governance. The focus is pragmatic: intended use, data integrity, traceability, controlled change, and audit-ready evidence.
Who it’s for
- Quality, compliance, and validation leaders in regulated environments.
- Product and IT owners responsible for systems that impact data integrity.
- Operations teams preparing for audits or scaling controlled change.
Problems we solve
- Unclear intended use and validation boundaries.
- Fragmented evidence that is difficult to trace.
- Change control and access controls that are inconsistently applied.
- Audit readiness that depends on heroics rather than a system.
- Security and operational controls not aligned to validation work.
Service focus
CSV / GAMP 5 / GDP validation
Validation is grounded in intended use and data integrity, with evidence that stands up to audit review.
- Classification
- Intended use
- Boundaries and interfaces
- Risk assessment
- URS
- Traceability matrix
- Test strategy and evidence
- Periodic review approach
Operational controls toolkit
Access control, change control, incident and problem practices, vendor oversight, and periodic review structures that keep compliance continuous.
What you get
- Validation strategy aligned to intended use
- Risk assessment and traceability matrix
- URS and test evidence structure
- Periodic review approach and schedule
- Operational controls toolkit for ongoing compliance
Engagement options
Short engagement
Focused assessment and remediation plan for a specific system or control gap.
Standard engagement
Validation delivery with full evidence, controls, and readiness support.
Extended engagement
Multi-system program with operating model design and governance rollout.
Diagnose
Clarify intended use, risk posture, and evidence gaps.
Build
Create validation artifacts, controls, and governance workflows.
Operate
Embed ownership, training, and review cycles for sustained compliance.
Relevant FAQ
What does risk-based validation mean in practice? +
It means focusing effort on what matters most to patient safety, data integrity, and operational impact.
We scale documentation and testing to the system’s intended use and verified risks.
Can you align CSV work with existing quality systems? +
Yes. We integrate with your existing QMS, SOPs, and approval workflows.
This reduces duplication and keeps evidence consistent across audits.
How do you approach GDP validation? +
We focus on data integrity, traceability, and controlled change across the data lifecycle.
Artifacts are structured to support audit expectations without unnecessary paperwork.
Is NIS2 support limited to readiness? +
Yes. We focus on readiness, gap assessment, and a practical roadmap.
We do not position the work as certification or formal audit assurance.
How do you keep evidence audit-ready over time? +
We define periodic review cycles and operational controls so evidence stays current.
Ownership and reporting are embedded into the operating model.
Do you support vendor oversight? +
Yes. We help define vendor review criteria, access control checks, and ongoing monitoring.
This keeps third-party systems aligned to your validation approach.
Ready to de-risk compliance?
Let’s align on scope and build a compliance system that supports delivery.