— For leaders in life sciences · Biotech · Pharma · Medical Technology
FDA‑confident AI Solutions and
AI governance—
without the audit scramble.
Your next FDA inspection may already be on the calendar. We help life sciences organizations pass audits with confidence and reduce validation burden—accelerating time to go-live with the people, process, and AI-driven technology behind modern CSA, QMS transformation, and responsible AI governance.
25+
Years in quality and compliance
60+
Life Sciences clients globally
FDA
Key contributor of CSA guidance FDA‑Industry CSA Team (FICSA) chair
AI‑native
PROPRIETARY CLAiRE, MAiGRATE & iQuality™
Trusted by life sciences leaders · Partnerships
Certifications
ISO/IEC 42001: 2023 Certified
Ethical and Well-Governed AI Secure, Transparent & Accountable Systems Scalable, Trust-Driven Innovation
SOC 2 Type 2 Compliant
Independently audited controls Proven operational effectiveness Security, availability & confidentiality assured
ISO/IEC 27001:2022 Certified
International information security standard Risk-based security management system Strong data protection & governance
You’re not imagining it
Quality leaders are being asked to do more with less—while FDA expectations get sharper.
The Quality Management System Regulation (QMSR) is live. CSA is reshaping validation. AI governance expectations are arriving faster than policies. And you’re carrying inspection accountability while the team scales faster than the quality system can keep up.
If any of these feel familiar, you’re not behind—you’re exactly where the industry is. The question is whether you’re set up to turn it into an advantage or a remediation project.
Validation drag is slowing launches.
Legacy validation approaches burn cycles on documentation instead of risk. Product timelines slip while validation teams script tests no auditor will ever read.
AI is in the building—governance isn’t.
Your teams are already using Artificial Intelligence for classification, summarization, and decision support. But there’s no defensible framework, no International Organization for Standardization / International Electrotechnical Commission (ISO/IEC) 42001 posture, and no audit-ready trail.
Audit trail reviews are a manual fire drill.
Multiple systems, multiple sub-modules, and no one has time to read them. Inspection prep becomes a war room instead of a standing capability.
Tribal knowledge is your biggest risk.
Change impact analysis depends on one or two experts. When they leave, institutional memory walks out with them—right before the next Pre-Approval Inspection (PAI).
Legacy Quality Management Systems (QMS) cost $1M+ and take 12–18 months.
You need a modern QMS and Document Management System (DMS), but not an enterprise implementation that consumes a year of executive bandwidth and half a budget cycle.
Staff augmentation treats you like a req, not a program.
Generic consultancies send bodies. You need people who already know CSA, GAMP 5 v2, 21 Code of Federal Regulations (CFR) Part 11 and Annex 11, International Electrotechnical Commission (IEC) 62304, and how your tools actually work.
The Industry Shift
Most life sciences organizations are dangerously behind on AI governance—and the FDA is already asking questions.
— Khaled Moussally · FDA–Industry CSA Team (FICSA)
Velocity Gap
3×
Faster validation cycle times for companies that modernized to CSA early versus those still following the 1998 CSV playbook.
Cost Exposure
$1M+
Typical cost of a single FDA Form 483 observation that triggers remediation, delayed approval, or re-submission cycles.
Closing Window
18mo
Between FDA’s final CSA guidance (2024–25) and when inspection expectations catch up to peer companies already implementing it.
A plan you can actually execute
Three steps to turn compliance into competitive velocity.
We don’t drop a 200-page report and leave. We assess, roadmap, and stay—so your team builds the muscle to sustain it after we’re gone.
01
Assess
Free AI & CSA Readiness Assessment
45 minutes with Khaled Moussally, FDA CSA Guidance Leader, or a senior CSA lead. We score your AI governance posture, validation approach, and inspection readiness against FDA’s latest guidance—then show you exactly where the gaps are.
45 min · No cost · Actionable
02
Roadmap
CSA & AI Governance Roadmap
We build the 90-day and 12-month plan: what to validate risk-based, where to apply AI, which Standard Operating Procedures (SOPs) to rewrite, and what to staff. Sequenced by audit risk and launch dependencies—not by whoever shouts loudest.
4–6 weeks · Fixed fee
03
Sustain
iQuality™ platform + Managed Services
Our AI-native QMS / DMS replaces the “digital filing cabinet” with continuous compliance intelligence (Document Xcellence – DX live now, Validation Xcellence – VX & Quality Xcellence – QX coming). Wrapped with managed services from the team that wrote the guidance.
From launch · Ongoing partnership
Meet Your Guide
We didn’t just read the CSA guidance. We helped build it and pioneered its adoption.
Before Compliance Group existed in 2017, our team had been practicing Computer Systems Validation (CSV) and CSA for 15+ years. When the FDA set out to modernize software validation, our Executive Vice President (EVP) Khaled Moussally chaired the FDA–Industry CSA Team (FICSA)— the only consulting firm in the consortium. He remains on the ISPE GAMP 5 v2 steering committee.
That’s why 60+ other life sciences organizations run multi-year managed services programs with us. We’re not a resource firm that picked up compliance work. We’re the subject matter experts your peers call when they need it done right.
FDA Credential
FICSA Chair
Chair of the FDA–Industry CSA Team. Co-authored sections of the final CSA guidance.
Industry Body
ISPE GAMP 5
Contributor to GAMP 5 Second Edition. Active steering committee member.
Partnerships
Siemens
Polarion
Certified implementation partner for Application Lifecycle Management (ALM), design controls, and traceability programs.
Proprietary AI
CLAiRE+
MAiGRATE
Agentic AI built for Life Sciences. AI-pipeline tooling for data migration pain.
Client Trust
60+clients
Including top-tier biotech and medical technology innovators. 95% of business is referral-driven.
Governance
ISO/IEC 42001
Our platform is built to the international AI management system standard. Plus ISO 27001 & System and Organization Controls (SOC) 2 Type II.
Integrated Service Pillars
People, process, and AI-powered technology—in one partner.
Most firms force you to choose: a consultancy, a resourcing agency, or a software vendor. We operate as all three, coordinated under one account team—so your compliance program gets consistent brains, hands, and tools.
Expert Consulting
CSA transformation, QMSR readiness, AI governance frameworks, audit remediation, GxP advisory, and FDA inspection preparation—led by practitioners, not generalists.
AI-Powered Technology Solutions
Siemens Polarion (ALM, design controls, requirements management). Veeva Vault implementations and managed services. Proprietary CLAiRE and MAiGRATE AI. And iQuality™— our own AI-native QMS platform.
Specialized Life Sciences Resourcing
CSV/CSA validators, Quality Assurance (QA) leads, Regulatory Affairs (RA) specialists, Polarion engineers, Veeva admins. On-shore, near-shore, off-shore, or hybrid. Flexible engagement—not a stack of resumes you have to re-interview.
Organizational Change Management & Microlearning
Compliance initiatives fail when people don’t adopt. We design role-based change programs and microlearning that drive actual adoption of new SOPs, platforms, and risk-based thinking—so the work sticks.
Life after the engagement
What it looks like when compliance compounds.
Your next move
Book your free Readiness Assessment.
45 minutes with a CSA expert. You’ll walk away with a scored readiness snapshot, the top three gaps we’d address first, and a clear view of what a 90-day modernization plan could look like. No pitch deck. No obligation.
Learn & Connect
Upcoming Events & Webinars
Explore upcoming events, expert-led webinars, and featured industry sessions.
