FICSA Co-Founders · GAMP 5 Second Edition Co-Authors · 300+ GxP System Knowledgebase
Stop validating like it’s 1997.
CSA cuts validation time by 70%. Be inspection-ready before the FDA knocks.
Computer Software Assurance isn’t just a regulatory update — it’s a strategic opportunity to validate systems in weeks instead of months, with documentation that reflects real risk. Most organizations adopted CSA as a checkbox. We implement it as a methodology change.
The CSA Reality Check
Peers who adopted CSA 18 months ago are moving 3× faster through FDA validation. Most teams who claim CSA adoption are still running the same validation cycles with fewer documents. That’s checkbox CSA — and auditors can tell the difference. We assess your systems, eliminate unnecessary validation effort, and build a compliant program — delivered in weeks, not months.
FICSA
Co-Founders
Compliance Group co-founded the FDA CSA guidance team that wrote the standard your program is measured against
300+
GxP system knowledgebase
No build-from-scratch. Pre-built risk classifications and testing approaches for every major platform
3×
Faster than legacy CSV
Peers who adopted CSA as a methodology change — not a documentation shortcut — move this much faster
Weeks
Typical cycle time
CSA-aligned programs that eliminate low-value documentation while strengthening what remains
What you’re dealing with
Why most CSA programs aren’t actually delivering on the promise.
Validation still feels like 2015
Smaller binders. Same test protocols. Same cycle times. The validation team still scripts tests no auditor will scrutinize — because the risk classification wasn’t actually done.
Critical thinking documentation is scripted
True CSA critical thinking is a rationale for risk-based decisions. What most teams produce is a paragraph that says “we decided this was low risk” without defensible reasoning behind it.
Retrospective validation backlogs keep growing
Legacy CSV documentation doesn’t reflect current system state. Every periodic review surfaces the gap. Every inspection reveals how wide it’s become.
New systems revert to old validation approaches
Without a CSA program design, each new validation project defaults to what the team knows — which is often the legacy approach they were trained on five years ago.
AI-using systems lack validation frameworks
When AI tools are used in validated workflows, most teams have no protocol for validating the AI layer — creating an undocumented compliance gap that inspectors are now specifically asking about.
GAMP 5 Second Edition creates new obligations
The updated standard explicitly addresses AI/ML systems and CSA principles. Organizations running GAMP 4-era programs are increasingly exposed under current inspection standards.
What we deliver
CSA consulting built on the guidance we helped write.
25+ years building and remediating validation programs for regulated life sciences organizations — from CSA strategy through full program execution. Our expertise is the product. Technology is a force multiplier we deploy when it’s the right tool.
Program Design
CSA Program Design and Transformation
From CSA strategy through full program execution: risk classification frameworks, critical thinking documentation templates, testing methodology, and team training. Built to hold up under FDA scrutiny — because we helped write the standard it’s measured against. We work with your existing validation team to shift methodology, not just produce documents.
Retrospective Remediation
Retrospective CSA Remediation
For organizations with legacy CSV documentation that doesn’t reflect current system state or CSA principles: structured gap assessment, prioritized remediation roadmap, and phased execution that doesn’t disrupt validated operations. We assess every system against current CSA and GAMP 5 Second Edition expectations — and fix what matters first.
AI/ML Validation
AI and Machine Learning System Validation
Validation protocols for AI/ML systems in GxP environments — aligned to FDA’s AI guidance, ISO/IEC 42001, and GAMP 5 Second Edition. As the team that holds ISO/IEC 42001 certification, we validate AI systems under the same governance framework we apply to our own AI products. No outsourced interpretation.
Ongoing Governance
Sustained CSA Program Governance
Validation programs degrade without active ownership. Compliance Group provides ongoing CSA program governance — periodic review oversight, change management, and continuous team development — so your CSA program stays current as systems, regulations, and your organization evolve.
FICSA co-founders. GAMP 5 Second Edition co-authors. 300+ GxP system validation knowledgebase. The team that wrote the guidance enforcing your compliance program.
Technology acceleration
CLAiRE AI and iQuality: the tools that multiply your CSA program’s speed.
Once your CSA methodology is right, these tools accelerate the work — automating the high-effort, repeatable tasks while your validation team focuses on the decisions that require expert judgment.
CLAiRE’s Validation Doc Generator automates URS/FS/DS drafting and generates CSA-aligned critical thinking rationale. iQuality VX handles end-to-end artifact generation and traceability. Together they don’t replace your CSA methodology — they execute it at machine speed.
- Automated URS, FS, and DS drafting aligned to your risk classification
- CSA-aligned critical thinking rationale generated — not templated
- Completeness and traceability review before human sign-off
- iQuality VX automates artifact generation across the full validation lifecycle
- Governed under ISO/IEC 42001 — every CLAiRE output is explainable and traceable
- Deploys on top of your existing validated stack. No rip-and-replace.
Years in quality & compliance
Regulated client organizations
Projects delivered globally
Client revenue generated
Your next move
Book a Free AI Readiness Assessment.
45 minutes with a senior expert—not a sales rep. Written risk brief included. No commitment. You walk away knowing exactly where your biggest regulatory exposure sits.