CSV Assessment & Roadmap
Understand your validation gaps before your next audit
CSV Assessment & Roadmap
Get a comprehensive assessment of your computerized systems against GAMP 5 and regulatory requirements. Receive a prioritized roadmap to remediate gaps and prepare for your next audit with confidence.
Assessment Approach
Week 1: System Inventory & Document Collection
We work with your team to create a comprehensive inventory of all GxP computerized systems across your organization. This includes commercial, quality, manufacturing, laboratory, and clinical systems.
We collect existing validation documentation, SOPs, and system documentation to understand your current state.
Week 2: Gap Analysis & Risk Assessment
Each system is evaluated against FDA 21 CFR Part 11 and EU Annex 11 requirements. Systems are classified according to GAMP 5 software categories to determine appropriate validation rigor.
We identify specific documentation gaps, process deficiencies, and compliance risks for each system.
Week 3: Roadmap Development & Executive Readout
We create a prioritized validation backlog based on risk, audit likelihood, and business criticality. Each remediation activity includes rough order of magnitude (ROM) estimates for time and cost.
The final deliverable includes an executive summary suitable for leadership, board members, or audit committees.
Ready to understand your validation gaps? Schedule an assessment call
What You Get
Six comprehensive deliverables to guide your validation remediation efforts.
Who This Assessment Is For
Pre-Commercial Biotech
Preparing for your first FDA inspection and need to understand validation requirements before regulators arrive at your door.
Upcoming Audits
Companies with upcoming audits or inspections who need to quickly understand their validation status and close critical gaps.
Fast-Growing Organizations
Organizations that have grown faster than their QA documentation, with systems deployed but validation work never completed.
System Evaluation
Teams evaluating new systems (QMS, LIMS, DMS, etc.) and need to understand validation requirements before procurement decisions.
Why Start with an Assessment
Avoid Audit Surprises
Know exactly where your gaps are before regulators find them. Be prepared with a clear remediation plan.
Prioritize Investment
Focus resources on highest-risk systems first. Get ROM estimates to build realistic budgets and timelines.
Executive Alignment
Clear communication to leadership about validation status, risks, and investment required for compliance.
Fast Turnaround
2-3 weeks from kickoff to final roadmap. Quick enough to inform immediate decisions without delaying business.
What Happens After the Assessment
Most clients choose one of three paths after receiving their CSV assessment:
Execute Validation Projects
We execute the validation work for your highest-priority systems, delivering complete IQ/OQ/PQ documentation.
Learn about System ValidationBuild Internal Capability
We develop your CSV program with SOPs, templates, and training so your team can execute independently.
Learn about CSV Program DevelopmentHybrid Approach
We validate the most complex systems while simultaneously building your internal capability for ongoing work.
Discuss Your NeedsReady to Understand Your Validation Gaps?
Schedule a free consultation to discuss your CSV assessment needs. We'll help you prepare for your next audit with confidence.
Schedule Assessment Call