Operationalize AI compliance for FDA, HIPAA, SEC, FINRA, AS9100, and ISO into working SOPs that reduce audit prep time by 70% and eliminate compliance violations.
Organizations in highly regulated sectors—healthcare, finance, aerospace, pharmaceuticals, food manufacturing, and government—that struggle with compliance burden, audit preparation, and policy implementation. Ideal for companies facing compliance violations, lengthy audit prep cycles, or manual compliance tracking overhead.
60-70% Reduction
Cut audit preparation from 3-4 weeks to 1 week through automated compliance tracking and documentation
100% Compliance
Eliminate audit findings and compliance violations through real-time monitoring and automated policy enforcement
$300K-$500K Annual
Avoid regulatory fines, reduce QA labor costs, and eliminate rework from compliance failures
24/7 Monitoring
Maintain audit-ready status year-round with automated compliance tracking and real-time violation detection
Comprehensive compliance framework tailored to your regulatory requirements (FDA/GMP, HIPAA, SEC/FINRA, AS9100, ISO) with AI-specific policy documentation and risk assessments
Working Standard Operating Procedures that integrate AI compliance into daily operations, including quality inspection protocols, documentation requirements, and audit trail processes
Digital compliance monitoring platform that tracks regulatory requirements, automates documentation, and provides real-time violation alerts with root cause analysis
Pre-built audit checklists, evidence collection templates, and compliance documentation that ensure audit-ready status 24/7
Compliance training programs for your team, change management support, and ongoing policy updates to maintain compliance as regulations evolve
We conduct a comprehensive assessment of your current compliance posture, regulatory requirements, and AI usage. This includes gap analysis, risk identification, and documentation review to understand where compliance automation will have the greatest impact.
We develop your regulatory compliance framework with operationalized SOPs, automated tracking systems, and audit templates. This includes AI-specific policy documentation, quality inspection protocols, and compliance monitoring workflows tailored to your regulatory requirements.
We implement the compliance framework, deploy automated tracking systems, and train your team on new SOPs. We provide change management support and conduct a mock audit to ensure audit-ready status before your next regulatory inspection.
2-3 Months
Initial implementation: 8-12 weeks. Includes assessment, framework development, system deployment, and training. Ongoing retainer available for policy updates and compliance monitoring.
20-30 Hours
Stakeholder interviews (8-10 hours), SOP review sessions (6-8 hours), training workshops (4-6 hours), and implementation support (4-6 hours). Minimal disruption to daily operations.
Timeline factors:
$25,000 - $75,000 + Retainer
Project-based pricing for initial implementation, plus optional monthly retainer ($3K-$5K/month) for ongoing compliance monitoring, policy updates, and audit support.
Our AI Policy Implementation service directly improves regulatory compliance, quality management, and operational efficiency metrics.
Compliance violation count
Audit findings (#)
Audit prep time (weeks)
Regulatory filing timeliness (%)
Training completion rate (%)
Compliance cost (% of revenue)
First-pass yield (%)
Defect rate (PPM or %)
Cost of quality (% of revenue)
Customer quality complaints
Rework/scrap rate (%)
Documentation completeness (%)
Our compliance framework integrates with your existing quality management systems, document management, and ERP platforms. We're tool-agnostic and work with your current infrastructure.
Risk: Framework doesn't meet regulatory requirements, leading to audit failures, violations, and potential fines or shutdowns.
Safeguard: We work with regulatory experts and conduct thorough requirements analysis before framework development. All frameworks are validated against current regulations and include mock audit testing. We provide regulatory update support to maintain compliance as requirements evolve.
Risk: Team doesn't adopt new SOPs or compliance processes, leading to continued violations and audit findings.
Safeguard: We provide comprehensive training, change management support, and work directly with process owners to ensure SOPs are practical and integrated into daily workflows. We conduct mock audits to validate adoption and provide ongoing support during transition.
Risk: Compliance tracking systems don't integrate with existing platforms, creating data silos and manual workarounds that undermine automation benefits.
Safeguard: We conduct technical integration assessment before implementation and design compliance frameworks that work with your existing systems. We provide API integrations, data migration support, and ensure automated workflows connect seamlessly with your QMS, ERP, and document management platforms.
Challenge: A $200M aerospace manufacturer spent 3-4 weeks preparing for each AS9100 audit and still received 8-10 minor findings. Manual traveler tracking, paper-based First Article Inspections (FAI), and scattered SOPs made compliance tracking overwhelming for the QA team.
Solution: We implemented AS9100 compliance automation with digital traveler tracking, automated FAI documentation, and integrated compliance monitoring. We developed operationalized SOPs that integrated AI-assisted quality inspection into existing workflows and created audit-ready documentation templates.
Impact: Reduced audit prep time from 3 weeks to 1 week (70% reduction). Achieved zero audit findings in next inspection. Eliminated $300K in annual QA labor costs from manual tracking. Maintained 24/7 audit-ready status with automated compliance monitoring.
Challenge: A 12-facility healthcare network struggled with HIPAA compliance for AI-powered patient engagement tools and clinical documentation systems. Manual compliance tracking, outdated policies, and lack of AI-specific guidelines created audit risk and operational burden.
Solution: We developed HIPAA-compliant AI policy framework with operationalized SOPs for patient data handling, AI-assisted clinical documentation, and automated compliance monitoring. We created audit templates, training programs, and integrated compliance tracking with their EHR system.
Impact: Achieved 100% HIPAA compliance with zero violations. Reduced compliance audit prep from 4 weeks to 1 week. Eliminated $200K in potential regulatory fines. Enabled safe deployment of AI patient engagement tools with full compliance documentation.
We specialize in AI-specific compliance—operationalizing regulatory requirements for AI systems, automated workflows, and AI-assisted processes. Unlike general compliance consultants, we understand how AI impacts regulatory requirements and create frameworks that integrate AI compliance into your operations, not just policy documents that sit on a shelf.
We design integrated compliance frameworks that address multiple regulations simultaneously, identifying overlaps and creating unified SOPs that satisfy all requirements. This is more efficient than managing separate compliance programs and reduces duplication. Pricing scales based on regulatory complexity.
We conduct mock audits before your actual inspection to validate compliance. Our frameworks are based on current regulatory requirements and validated by regulatory experts. We provide audit-ready documentation templates and ensure your team is trained on audit procedures. Most clients achieve zero findings on their first audit after implementation.
We offer ongoing retainer services ($3K-$5K/month) that include regulatory monitoring, policy updates, and framework adjustments as regulations evolve. We track regulatory changes in your industry and proactively update your compliance framework to maintain audit-ready status.
Yes, we offer accelerated implementation timelines (4-6 weeks) for urgent audit prep. We prioritize critical compliance gaps, implement quick-win automation, and ensure audit-ready documentation. While full framework development takes 8-12 weeks, we can get you audit-ready faster for immediate needs.
We design compliance frameworks that integrate with your existing QMS, document management, and ERP systems. We provide API integrations, data migration support, and ensure automated compliance tracking connects seamlessly with your current infrastructure. We're tool-agnostic and work with MasterControl, ETQ, SharePoint, Veeva, and other platforms.
Service #8 focuses on operationalizing regulatory compliance (FDA, HIPAA, SEC, etc.) into working SOPs and automated systems. Service #4 focuses on broader AI governance—AI usage policies, risk frameworks, and evaluation metrics. Many clients use both: #4 for overall AI governance, #8 for specific regulatory compliance. We can help you determine which service fits your needs.
Book a 20-minute fit call to discuss how AI Policy Implementation can reduce your audit prep time by 70% and achieve zero compliance violations.
Add ongoing compliance monitoring and real-time violation detection to maintain audit-ready status year-round.
Develop broader AI governance frameworks, risk management policies, and AI usage guidelines beyond regulatory compliance.
Last updated: November 2025