Services
AI Compliance Support
AI is moving fast. Regulators are catching up. Is your organization ready?
Artificial intelligence is transforming how regulated industries operate. From quality systems and eConsent platforms to pharmacovigilance, manufacturing, and regulatory submissions. The promise is real. So is the risk.
Most organizations are eager to adopt AI. Very few have a clear, defensible compliance strategy around it.
At 11 Compliance, we do. We bring the same deep regulatory expertise that guides our eQMS, validation, and 21 CFR Part 11 work directly into the AI space, helping you adopt AI confidently, compliantly, and without putting your data integrity, your submissions, or your patients at risk.
If you’re still figuring out where AI fits in your organization, we can help with that too. Before compliance comes clarity, knowing which tools are right for your specific needs, how to evaluate them, and how to integrate them responsibly into your workflows. We offer light-touch AI advisory to help you cut through the noise, so you adopt the right tools for the right reasons, and then make sure they’re compliant from day one.
Our AI Compliance & Validation services include:
- AI System Validation: AI systems are not static software. They evolve, adapt, and behave differently as they encounter new data. Traditional CSV approaches don’t fully account for this. We design and execute validation strategies specifically built for AI and machine learning systems operating in GxP environments, ensuring your systems are defensible, documented, and inspection-ready.
- 21 CFR Part 11 Assessments for AI-Enabled Systems: Any AI tool that captures, processes, or generates electronic records or signatures in a regulated environment must meet Part 11 requirements. We assess your AI-enabled platforms, including AI-powered eQMS, eConsent, and clinical data systems, and provide a clear remediation roadmap to bring them into full compliance.
- AI Governance & SOP Development: Regulators expect you to manage AI the same way you manage any other controlled process with documented procedures, defined oversight, and clear accountability. We develop the SOPs, risk assessments, change control processes, and governance frameworks your organization needs to operate AI responsibly in a GxP environment.
- GxP AI Risk Assessments: Not every AI tool your organization uses carries the same level of risk. We conduct structured risk assessments of your AI systems and workflows, helping you prioritize compliance efforts, allocate resources effectively, and demonstrate a defensible, risk-based approach to regulators.
- AI Compliance Training: Your teams are adopting AI tools faster than your training programs can keep up. We develop and deliver role-specific training that builds AI literacy, establishes compliant use practices, and ensures your staff understands both the opportunity and the obligation that comes with AI in a regulated environment.
Keeping you in compliance with a partner who understands the industry and systems. “Your success is Our success”
Comprehensive Training Solutions
Maximizing System Value Through Effective Learning
From end users to administrators, we bring real-world experience to create realistic simulations and hands-on training—centered around your business processes.
And if those processes aren’t yet documented, we can help with that too.
Our training solutions are flexible, scalable, and tailored to your organization’s needs and budget:
- eLearning development: Custom content aligned with your workflows and business goals, delivered in clear, high-quality formats.
- Train-the-Trainer Programs: Empower your internal team to deliver consistent, effective training with confidence.
- Facilitated Training & eLearning: Instructor-led or self-paced options designed for maximum retention and accessibility.
- Curriculum development: Addressing learner needs and business culture to ensure curriculum relevance, with clearly defined goals and objectives.
- Tailored Documentation: SOPs, user guides, manuals, job aids, and other materials to ensure clarity, usability, and compliance.
- User Adoption Support: Marketing and communication materials to drive awareness, engagement, and acceptance.
- LMS Consulting: Guidance and configuration support to optimize your learning management system for delivery and tracking.
After months of planning, configuring, and preparing for go-live, training often arrives as a last-minute hurdle. With limited time and resources, it can feel overwhelming.
At 11 Compliance Consulting, we simplify the process by delivering not only expert system implementation but also role-specific training programs that ensure lasting adoption and compliance.
We enjoy training—and it shows. Our passion translates into engaging, customized learning experiences that equip your teams with the knowledge and tools they need to succeed.
Stay compliant with a partner who understands your systems—and knows how to train your people. “Your success is Our success”
Validation
Quality expertise + efficiency: optimizing and trusting system performance.
It can feel daunting to now add validation onto the plate. With teams stretched to cover ongoing operations, a new system rollout, migration, there is limited bandwidth to address. There may not even be the expertise to do validation, and it would be time consuming to try to learn.
At 11 Compliance Consulting, our validation services ensure you have the utmost confidence in your system’s performance. We design our validation processes around your documented business process. Our team focuses on ensuring your system is validated while taking the least burdensome approach, utilizing risk to mitigate testing while not losing sight of data integrity and system security.
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• Verification of compliance with FDA 21 CFR part 11 and EMA Annex 11 pertaining to
electronic records. - • Development of Validation Documentation
- • Validation Plan
- • User Requirement Specifications
- • System Specification (Functional, Configuration etc.)
- • Installation, Operational, and Performance Qualifications.
- • Risk Assessments and migration strategies.
- • Final validation report
- • Vendor documentation assessment and acceptance strategy
- • System usage procedures (see Training)
- • Lifecycle management procedures
Keeping you in compliance with a partner who understands the industry and systems. “Your success is Our success”
Quality Software Implementation
A configuration can make or break system usability. Cookie-cutter solutions can be cumbersome, inadequate, or not intuitive to your company’s processes. Too much design makes it difficult to get anything done. Too little, and you’ll be plagued with quality issues errors, missed handoffs, and confusion.
- • Configuration consulting bringing in industry-specific best practices and methodology
- • New process development and documentation
- • Problem-solving and issue resolution
Keeping you in compliance with a partner who understands the industry and systems. “Your success is Our success”
Fully Managed QMS SaaS Solution
11 Compliance Consulting delivers Managed Services and Fully Managed SaaS Solutions
A complete, cloud-hosted Quality Management System — delivered as a managed service so your team can focus on what matters most.
Managing a quality system takes time, expertise, and resources many organizations don’t have to spare. Whether you need to reduce internal IT burden or simply want a reliable, compliant system without the overhead, 11 Compliance Consulting can maintain your QMS end-to-end in our hosted system or yours.
Infrastructure & Security:
- Fully managed QMS with maintenance and dedicated support, reducing IT burden and eliminating additional hardware investments
- Secure cloud-hosted platform with managed backups and access controls for reliable access to quality documentation
- Minimizes downtime through proactive system monitoring and rapid issue resolution
- Offers predictable costs through a subscription-based model
Compliance & Operations:
- Simplifies compliance with automated updates, audit readiness support, and controlled document management
- Accelerates onboarding with expert configuration, user training, and hands-on support
- Centralizes quality workflows, records, and documentation in a single platform
- Ongoing access to feature updates, system enhancements, and validation support
Keeping you in compliance with a partner who understands the industry and systems. “Your success is Our success”
Quality System Support
Are You Really Ready for an Inspection?
An FDA inspector arrives at your facility. Your last mock audit was two years ago. A key vendor hasn’t been re-qualified since onboarding. Your eConsent platform was never formally assessed against 21 CFR Part 11.Are you confident?
At 11 Compliance, we make sure the answer is always yes. We specialize in Quality Software Implementation and Quality System Support designed to close compliance gaps before regulators find them — protecting your data, your products, and your business.
From software implementation and system validation to audit readiness, vendor qualification, and regulatory compliance support, we help organizations deploy and maintain compliant, efficient, and reliable systems with confidence. Our team works directly with you to translate complex regulatory and business requirements into practical, streamlined solutions that support operational success and long-term growth.
You won’t be handed off to a junior associate. You work with our experts, every time.
21 CFR Part 11 Assessments
If it captures an electronic record or signature, it needs to be compliant. Full stop.
Regulators are scrutinizing electronic systems more closely than ever. Whether it’s the platform collecting electronic consent forms from your study participants or the Quality Management System running your entire quality operation, if it touches electronic records or signatures, it must meet 21 CFR Part 11 requirements — no exceptions.
A non-compliant system doesn’t just create a regulatory finding. It puts your data integrity at risk, exposes your organization to warning letters, and in the case of eConsent, compromises the protections your participants deserve.
At 11 Compliance, we assess any system that falls under 21 CFR Part 11 scope — including eConsent platforms, QMS software, and other electronic systems across your quality and clinical operations. We identify exactly what’s out of compliance and tell you precisely what needs to be fixed.
Our Part 11 assessments cover:
- eConsent platforms — audit trails, signature workflows, participant recordkeeping
- QMS software — validation status, access controls, electronic record management
- Any GxP system capturing electronic records or signatures across your organization
- Gap analysis with risk-prioritized remediation recommendations
- Support through remediation and re-assessment through to closeout
Your electronic systems should give you confidence — not keep you up at night. We make sure they do.
Not certain your systems are fully Part 11 compliant? Let’s take a look
ISO Certification Remediation
A failed certification isn’t the end. It’s the beginning of getting it right.
Non-conformances don’t have to mean a missed certification. They mean something in your quality system needs attention — and with the right partner, you can fix it, document it, and demonstrate it to your certifying body with confidence.
At 11 Compliance, we identify root causes, implement targeted corrective actions, and prepare your quality system to meet ISO standards so that your certification is not just achievable — it’s sustainable.
- Gap assessment against applicable ISO standard requirements
- Root cause analysis of non-conformances
- Corrective and Preventive Action (CAPA) development and implementation support
- Certification preparation and mock assessment prior to formal audit
Our ISO remediation clients have achieved certification on their first re-attempt. Yours can too.
Ready to turn your non-conformances into a certification success?
GxP Vendor Audits
Your vendors are part of your quality system. Are they holding up their end?
An unqualified vendor can invalidate your data, compromise your supply chain, and trigger a warning letter — and you may not find out until it’s too late. Our GxP vendor audit services provide independent, thorough evaluations of your suppliers and service providers against current regulatory expectations and your internal quality standards.
We don’t just identify the gaps. We help you close them.
- Independent, risk-based evaluation of vendor compliance
- Assessment against GMP, GCP, and GLP requirements as applicable
- Detailed findings report with prioritized corrective action recommendations
- Ongoing vendor qualification support and re-audit programs
Our clients have used our GxP vendor audit findings to proactively remediate supplier gaps — before those gaps appeared on an FDA inspection report.
Not sure your vendors would pass a regulatory audit? Let’s find out.
Mock Pre-Approval Inspection (PAI) Audits
A failed PAI doesn’t just delay your launch — it can derail it entirely.
The FDA’s Pre-Approval Inspection is one of the highest-stakes moments in a product’s lifecycle. One critical finding can set your launch back by months or years. Our mock PAI audits simulate the real inspection experience — the questions, the document requests, the scrutiny — so your team knows exactly what to expect and how to respond.
- Full simulation of FDA PAI processes and expectations
- Comprehensive review of manufacturing, documentation, and quality systems
- Debrief and gap analysis with prioritized remediation guidance
- Inspection response coaching for your key personnel
We have helped clients walk into FDA Pre-Approval Inspections with complete confidence — and walk out with zero critical findings.
Is your team inspection-ready? Let’s make sure.
Mock Bioresearch Monitoring (BIMO) Audits
Clinical data integrity is non-negotiable. Don’t wait for the FDA to tell you there’s a problem.
An FDA BIMO inspection scrutinizes how your clinical research is conducted, documented, and overseen. Findings can jeopardize your data, your study, and your regulatory submissions. Our mock BIMO audits assess your investigator sites, study teams, and supporting documentation against FDA expectations — so you identify vulnerabilities on your terms, not theirs.
- Site and sponsor/CRO readiness assessments
- Review of clinical documentation, protocols, and informed consent processes
- Staff interview preparation and regulatory response coaching
- Findings report with clear, actionable remediation steps
Inspection day should hold no surprises. We make sure it doesn’t.
Ready to stress-test your clinical operations?
Keeping you in compliance with a partner who understands the industry and systems. “Your success is Our success”
