Expert-Led. Continuously Governed. SLA-Backed.
Platform governance that runs itself—because yours shouldn’t have to.
Compliance Group Managed Services delivers expert-led, continuously governed management of Veeva Vault, Polarion ALM, QMS/DMS, eTMF, CTMS, and IT compliance systems—through a governed, scalable model that costs 40–60% less than traditional consulting.
The Managed Services Gap
Most life sciences organizations manage validated systems reactively—mobilizing expensive consultants before inspections, scrambling when platforms release quarterly updates. Zero audit findings across all Compliance Group managed programs. 40–60% below traditional consulting rates.
0
Audit findings across managed programs
Across all Compliance Group managed service engagements
40–60%
Below traditional consulting rates
Governed delivery model with follow-the-sun capability
95%
Client renewal rate
Year-over-year. Programs that work don’t get cancelled.
24/7
Follow-the-sun support
Global coverage across all managed programs — no gaps in governance.
What success looks like
What your validated environment looks like under Compliance Group managed governance.
Always inspection-ready
Continuously validated state. Audit evidence assembled in minutes. No pre-inspection scramble—because there’s nothing to scramble for.
40–60% below traditional rates
Governed delivery model with follow-the-sun capability. Expertise at scale without per-head consultant billing.
Zero unplanned outages
SLA-backed governance with defined response times. Changes are controlled. Platform releases are managed before they become problems.
Your team focuses on the business
Platform governance, periodic reviews, change management—handled. Your quality team focuses on what requires their expertise.
The platform governance problem
Validated platforms degrade over time—unless someone is actively governing them.
Most organizations implement Veeva or Polarion and move on. Six months later, the validated state starts drifting. A year later, there’s a backlog of periodic reviews, unmanaged changes, and a pre-inspection sprint that costs three times what proactive governance would have.
Quarterly platform releases slip through unvalidated
Vendors release updates quarterly. Each one is a potential validated-state event. Most teams notice the problem at the next audit, not at release.
Periodic reviews are perpetually backlogged
They were scheduled. Then someone left. Then inspection prep started. Now there are 18 months of overdue reviews in the queue.
Change management happens after the change
Someone configured a workflow change without a change request. Now the audit trail shows a configuration you can’t explain under validation.
The validated state drift compounds
A small gap becomes a medium gap becomes a significant finding. By the time it surfaces in an audit, remediation takes months and costs multiples of what prevention would have.
Traditional consulting rates don’t scale with governance
Ongoing governance at $250–$350/hour per consultant doesn’t match the economics of a sustained managed service. It matches a crisis response.
AI governance creates new platform obligations
If AI tools are used in validated workflows, there are new audit trail, oversight mechanism, and governance documentation requirements.
Platform Coverage
Expert governance for the platforms your compliance program depends on.
Certified Veeva Partner
Veeva Vault — QMS, eTMF, CTMS, RIM, PromoMats
Configurations, enhancements, connectors, API, and quarterly release support. Quality Suite, RIM Suite, Clinical Suite, Safety Suite. User, role, and security management. Periodic review readiness and audit preparation. CLAiRE AI Audit Trail Review overlay — 100% daily ATR coverage.
Certified Siemens Partner
Polarion ALM — Design Control & ALM
Templates, configuration, and dashboards. Lifecycle optimization and process governance. Ongoing admin support, enhancements, and structured service desk. CLAiRE Nova Polarion Copilot — AI compliance intelligence embedded natively. Data never leaves your server.
Quality Systems
QMS / DMS / eTMF / CTMS
Document control governance, SOP management, CAPA and deviation workflow administration, change control management, user training, and ongoing platform optimization. eTMF and CTMS ongoing validation and release governance. Periodic review readiness and audit preparation.
Infrastructure & IT Compliance
LIMS & IT Compliance
21 CFR Part 11 and Annex 11 compliance monitoring, audit trail governance, and system inventory management. CMDB integration and AI governance overlay for AI-enabled systems. LIMS validation, release management, and ongoing configuration governance.
Every Managed Services engagement includes optional CLAiRE AI Agentic Platform overlay — Audit Trail Review (100% daily ATR on Veeva), CLAiRE Nova Polarion Copilot, Continuous Quality Monitoring, and User Access Reviews running continuously on top of your governed platforms. No rip-and-replace. Deploys in weeks. Built on the ISO/IEC 42001-certified platform that governs all Compliance Group AI tools.
The Compliance Group Advantage
Disciplined scalability. Mature governance. Modern AI tools.
Clients get flexible capacity, risk-based delivery methods, AI-supported acceleration, and consistent operations across every engagement — at 40–60% below what reactive consulting costs.
CSA & CSV Validation & Qualification Quality Systems ALM / SDLC QMS / DMS Governance Digital Validation AI Governance FICSA Co-Founders GAMP 5 Second Edition Co-Authors ISO/IEC 42001 CertifiedYears in quality & compliance
Regulated client organizations
Projects delivered globally
Client revenue generated
Managed Services is the operational layer. Strategic Consulting defines the program. Specialized Resourcing provides surge capacity when your team needs it. OCM & Microlearning ensures adoption when new platforms go live. All four service lines work together — or independently, based on what you need.
Your next move
Stop governing your platforms reactively.
Book a Free Assessment with a senior Compliance Group practitioner. We’ll review your current platform governance model, identify where validated state is drifting, and scope an engagement that costs less than your next pre-inspection sprint.