Name: Gap Assessment Toolkit
Brand: RegulatoryIQ
Price: 499.00 USD
Availability: InStock

AI-Powered

AI Gap Analysis

Upload any compliance document and get a structured gap assessment report in under 60 seconds. Our AI evaluates your document against clause-level regulatory criteria and produces risk-rated findings with specific remediation actions.

Frameworks

431

Total Criteria

<60s

Analysis Time

Single Analysis — $79 3-Pack — $199 (save $38)

See how it works — Interactive Demo

Your documents are never stored. Zero-data-retention AI processing. 256-bit encrypted transmission. PDF report is your only deliverable.

How It Works

01

Upload your document

PDF format · SOPs, policies, validation plans, work instructions · Up to 50 pages
02

Select a regulatory framework

FDA Part 11 · FDA CSA (Feb 2026) · ALCOA+ · ICH E6(R3) · QMSR/ISO 13485
03

Get your gap analysis report

Risk-rated findings · Clause-level citations · Specific remediation actions · Downloadable PDF

What You Get

Findings cite your document's actual section numbers and content

Risk ratings calibrated to real FDA 483 and inspection outcomes

Remediation actions specific enough to assign to your team today

Zero data retention. Your documents are never stored or used for training

Don't have compliance documents to analyze?

Start with our audit-ready template packs. Build your SOPs, gap assessments, and compliance documentation, then run them through AI analysis to validate coverage.

Gap Assessment Toolkit ($499) CSV/CSA Package ($199) Part 11 Pack ($299) Data Integrity Pack ($179) TPS/COTS FFU Toolkit ($279)

Want us to review your AI analysis and build the remediation plan?

Run the AI analysis first, then bring the report to a discovery call. We validate findings, prioritize remediation, and support you through closure.

Book a Discovery Call

Why It Matters

The cost of finding gaps late

Regulatory gaps found during an inspection cost 10-100x more to resolve than gaps found proactively. Every FDA warning letter, every product recall, and every consent decree traces back to documentation gaps that could have been identified with a thorough review.

$5M-50M+

Average cost per FDA warning letter including remediation, revenue impact, and regulatory commitments

6-18 months

Typical 483 observation remediation timeline, during which new product approvals may be delayed

$10M+

Average product recall cost including field actions, replacement, investigation, and corrective measures

$79

RegulatoryIQ AI gap analysis. Find documentation gaps in 60 seconds, before your auditor does

The business case is straightforward

A single undetected gap in an SOP can trigger a 483 observation, which can escalate to a warning letter if left unresolved. Warning letters halt product approvals, trigger stock drops for public companies, and require months of remediation effort. Running your critical documents through a gap analysis before submission, before an audit, or as part of your annual review is the lowest-cost insurance available. The question is not whether you can afford $79 for an AI analysis. The question is whether you can afford not to.

Regulatory Intelligence

Current as of March 2026

Every citation verified. Every framework tracked. Our templates and assessments reflect the latest regulatory landscape.

Effective Feb 3, 2026

FDA Computer Software Assurance

Level 2 revision of the CSA final guidance. Title updated to "Quality Management System Software" aligning with the QMSR/ISO 13485 harmonization. Risk-based approach: intended use, process risk assessment, proportionate assurance activities, objective evidence. Supports unscripted testing and digital evidence over paper documentation.

FDA CSA Final Guidance (Feb 2026) · Supersedes Sept 2025 version · Replaces GPSV Section 6

Effective Feb 2, 2026

QMSR / 21 CFR Part 820 Transition

The QMSR final rule withdrew the majority of Part 820 requirements and incorporated ISO 13485:2016 by reference. All quality management system documentation should now reference ISO 13485:2016 as incorporated by 21 CFR Part 820. 21 CFR Part 11 remains independently applicable and is not affected by this change.

21 CFR Part 820 (QMSR) · ISO 13485:2016 incorporated by reference · Part 11 unchanged

Step 4 Final Guideline

ICH E6(R3) Good Clinical Practice

Finalized January 6, 2025 and published January 14, 2025. This is the definitive GCP guideline, not a draft. Step 5 regional implementation timelines vary by jurisdiction; EU implementation expected under the Clinical Trials Regulation (EU CTR 536/2014). Organizations should verify their regulatory authority's implementation date.

ICH E6(R3) Step 4 · Adopted Jan 6, 2025 · Published Jan 14, 2025

Live FDA Data

FDA Inspection Intelligence

266,000+ inspections. 271,000+ citations. Exposed patterns the industry talks about but rarely quantifies. Data sourced directly from FDA's public inspection database.

Total Inspections

266,037

FY2009 – FY2025

Citation Records

271,567

All program areas

Official Actions (OAI)

12,685

3.9% of all outcomes

FY2025 Device OAI Rate

5.1%

125 official actions

Inspection Outcomes by Fiscal Year

Classification distribution across NAI, VAI, and OAI outcomes. COVID-19 impact visible in FY2020-2021 with recovery through FY2025.

OAI Rate by Product Type

Percentage of inspections resulting in official action, FY2021-FY2025.

Citation Volume by Program Area

Annual citation counts for regulated industries, FY2015-FY2025.

Top Device Citations (FY2023 – FY2025)

Most frequently cited CFR sections in FDA device inspections over the last three complete fiscal years.

CFR Section	Description	FY23	FY24	FY25	3-Year Total

Device Citation Trend (FY2015 – FY2025)

Total device-related citations issued per fiscal year. Post-pandemic volumes have stabilized near pre-2020 levels. *FY2026 is partial (through March 2026).

Top Drug Citations (FY2023 – FY2025)

Most frequently cited 21 CFR Part 211 sections in pharmaceutical inspections. Drug manufacturing consistently draws higher OAI rates than any other FDA-regulated product type.

CFR Section	Description	FY23	FY24	FY25	3-Year Total

Drug OAI Rate: Persistently the Highest

Official Action Indicated rate for drug inspections versus devices and biologics.

Part 820 Citation History: Now Under QMSR

The top-cited Part 820 subsections across all device inspections FY2009-FY2025. Effective February 2, 2026, the QMSR replaced the majority of Part 820 with ISO 13485:2016 incorporated by reference.

820 Section	Observation	All-Time Citations

Why This Matters Now

With the QMSR effective February 2, 2026, every one of these historically cited Part 820 sections now maps to an ISO 13485:2016 clause. The top three areas alone—CAPA procedures, complaint handling, and quality audits—account for over 10,000 citations in the FDA's inspection database. Our Gap Assessment Toolkit maps each of these high-risk areas to the corresponding ISO 13485 requirement and evaluates your current state against both frameworks.

QMSR in Practice: First 30 Days

FDA inspection data through February 20, 2026 already shows the QMSR transition in enforcement. Across 13 device inspections completed after the February 2 effective date, FDA issued 33 citations. Of these, 31 cite ISO 13485:2016 clauses directly and zero reference Part 820. The most-cited clauses so far: Clause 7.1 (product realization planning, 4 citations), Clause 8.5.2 (corrective action, 3), Clause 7.5.6 (process validation, 3), and Clause 4.1.2 (risk-based QMS approach, 3). The enforcement priorities mirror the historical Part 820 patterns above—CAPA, process validation, and production controls remain top focus areas—but the citation format has shifted to ISO 13485 clause references.

EU GMP Inspection Volume (2015 – 2025)

GMP certificates, non-compliance reports, and deficiency acknowledgments issued by EEA competent authorities. Volume has more than doubled since pre-COVID levels.

Non-Compliance Rate by Year

Percentage of inspections resulting in a GMP non-compliance statement. Rate is climbing back toward pre-pandemic levels after COVID-era lows.

Non-Compliance by Country

India and China account for 59% of all EU GMP non-compliance statements issued since 2015. 97 total NC reports across 24 countries.

Geographic Risk: NC Rate by Manufacturing Origin

Non-compliance rate as a percentage of total inspections for countries with 50+ GMP inspections since 2015. Third-country manufacturers face significantly higher NC rates.

Country	Inspections	NC Reports	NC Rate

Supply Chain Risk Intelligence

EU inspection volume increased 116% from 2019 to 2024, signaling intensified regulatory scrutiny of global pharmaceutical supply chains. For organizations sourcing APIs or finished products from India or China, these non-compliance patterns should inform vendor qualification, audit frequency, and supply chain risk assessments. Our Gap Assessment Toolkit and Audit Prep Bundle include supplier qualification criteria aligned to EU GMP Annex 11 and EudraGMDP compliance expectations.

Data sources: FDA ORA Compliance Dashboards · EudraGMDP (EMA)
FDA data updated weekly; final classifications only. Excludes state-conducted, pre-approval, mammography, and nonclinical lab inspections.
EU GMP data from EudraGMDP public database. Populated by EEA national competent authorities. UK data excluded post-January 2021 per Brexit transition.

Data through March 2026

Capabilities

Six pillars of compliance intelligence

From initial gap assessment through audit preparation, every service maps to specific regulatory requirements and delivers actionable outcomes.

Regulatory Document Review

Expert analysis of your SOPs, validation protocols, and quality system documentation against applicable regulatory frameworks. Identifies non-conformities, maps requirements to existing evidence, and delivers risk-prioritized findings with specific clause references.

21 CFR Part 11 · ISO 13485 · EU MDR

Third-Party Software (TPS) / COTS Fit-for-Use Assessment

GAMP 5 2nd Edition categorization with FDA CSA (Feb 2026) risk-based evaluation framework. Vendor assessment, intended use documentation, and process risk determination for commercial off-the-shelf (COTS) and configured products.

GAMP 5 · FDA CSA · Vendor Qualification

Gap Assessment & Remediation

Clause-level gap identification with risk-rated findings and prioritized remediation plans. Each gap maps to specific regulatory clauses with recommended corrective actions, responsible parties, and target timelines.

Risk-rated · Clause-level · Actionable

QMSR Transition Support

Navigate the shift from 21 CFR Part 820 to ISO 13485:2016 under the QMSR, effective February 2, 2026. Gap analysis of your current QMS against ISO 13485 requirements, documentation crosswalk, and transition planning with defined milestones.

QMSR · ISO 13485:2016 · 21 CFR Part 820

SaMD & Clinical Trial Support

IMDRF classification, IEC 62304 software lifecycle, IEC 62366-1 usability engineering, and ISO 14155 clinical investigation planning. End-to-end support from software classification through clinical evidence generation.

IMDRF · IEC 62304 · IEC 62366-1 · ISO 14155

Data Integrity & Security

ALCOA+ assessment methodology, audit trail reviews, 21 CFR Part 11 electronic records/signatures compliance. Covers the 2003 Scope and Application guidance and 2024 expanded interpretation for cloud and digital health technologies.

ALCOA+ · 21 CFR Part 11 · Audit Trails See the Part 11 Complete Pack

Now Available

Gap Assessment Toolkit

$897 $499 One-time purchase

Total value if purchased separately: $897. You save $398.

Eight audit-ready templates with 535 assessable criteria covering six major compliance frameworks. Every regulatory citation has been verified against current published versions as of February 2026. Designed for FDA, EMA, and MHRA inspection preparation.

Get the Toolkit — $499

Digital delivery via email within 1 business hour during business hours (typically within minutes).

30-day money-back guarantee. If the toolkit doesn't meet your compliance needs, we'll refund your purchase.

A regulatory consultant charges $300-500/hour. This toolkit replaces weeks of manual gap assessment work.

What's Included

xlsx

FDA 21 CFR Part 11 Gap Assessment

46 assessable criteria
xlsx

EU GMP Annex 11 Gap Assessment

139 assessable criteria
xlsx

ICH E6(R3) Assessment Tool

101 assessable criteria
xlsx

Data Integrity ALCOA+ Assessment

69 assessable criteria
xlsx

CSV/CSA Assessment Template

80 assessable criteria
xlsx

QMSR / ISO 13485:2016 Gap Assessment

100 assessable criteria · Includes 820-to-13485 mapping & transition readiness
docx

Remediation Plan Template

12-column gap register · 12 regulatory references
docx

Executive Summary Template

12 sections · Placeholder variables for criteria counts

Why This Toolkit

Every regulatory citation verified against current published versions

6 major compliance frameworks in one integrated toolkit

Risk-rated criteria with built-in remediation tracking

Ready for FDA, EMA, and MHRA inspection preparation

Dual CSV/CSA framework coverage for organizations in transition

Want us to perform the gap assessment for you?

Our regulatory team conducts full compliance gap assessments across all six frameworks, delivers findings with risk-rated remediation plans, and supports you through closure. 14+ years of hands-on audit experience.

Book a Discovery Call

Now Available

CSV/CSA Package

$199 One-time purchase

Six audit-ready templates covering the FDA Computer Software Assurance (Feb 2026) framework transition from traditional CSV. Aligned to the risk-based approach: intended use, process risk, assurance activities, and objective evidence. Built for organizations transitioning from CSV to CSA or implementing CSA from scratch.

Get the CSA Package — $199

Digital delivery via email within 1 business hour during business hours (typically within minutes).

30-day money-back guarantee. If the package doesn't meet your compliance needs, we'll refund your purchase.

Aligned to FDA CSA Final Guidance (Feb 2026), GAMP 5 2nd Edition, QMSR/ISO 13485:2016, and 21 CFR Part 11.

What's Included

xlsx

CSA Implementation Gap Assessment

80 assessable criteria
xlsx

Software Categorization & Risk Assessment Tool

5 worksheets · 29 dashboard formulas
docx

Computer Software Assurance Plan

10 sections · 6-step methodology
docx

Vendor Assessment Questionnaire

61 questions · 24 critical
docx

CSA Testing Protocol Template

3 parts (scripted/unscripted/vendor) · 24-item evidence checklist
xlsx

CSV-to-CSA Transition Checklist

68 items across 4 phases · Auto-calculating dashboard

Why This Package

Updated to the Feb 2026 CSA final guidance (supersedes Sept 2025 version)

Covers both legacy CSV and modern CSA approaches for organizations in transition

Vendor assessment questionnaire with 24 critical-path questions

All templates cross-referenced by document number (RIQ-CSA-xxx)

Want us to handle your CSA transition?

We assess your current CSV practices, build your CSA implementation roadmap, categorize your software portfolio, and guide you through the transition. From gap analysis to inspection readiness.

Book a Discovery Call

Now Available

Data Integrity Pack

$179 One-time purchase

Five audit-ready templates for ALCOA+ compliance and data governance. Covers the full data integrity lifecycle from gap identification through risk assessment, with a dedicated 21 CFR Part 11 companion assessment and complete SOP and audit trail review procedures.

Get the Data Integrity Pack — $179

Digital delivery via email within 1 business hour during business hours (typically within minutes).

30-day money-back guarantee. If the pack doesn't meet your compliance needs, we'll refund your purchase.

Aligned to FDA 21 CFR Part 11, EU GMP Annex 11, MHRA data integrity guidance (2018), PIC/S PI 041-1 (2021), and WHO TRS 1033 Annex 4 (2021).

What's Included

xlsx

Data Integrity Gap Assessment

117 assessable criteria · 4 worksheets (ALCOA+ principles)
docx

Data Integrity SOP

29 sections · Full data lifecycle management
docx

Audit Trail Review Procedure

25 sections · Risk-based review methodology
xlsx

Data Integrity Risk Assessment Tool

7 worksheets · 45 pre-populated risks · 342 formulas (RPN model)
xlsx

21 CFR Part 11 Companion Assessment

55 criteria across 9 sections · 4 worksheets

Why This Pack

117 gap criteria mapped to ALCOA+ principles at the clause level

Risk assessment with 45 pre-populated scenarios and automatic RPN calculation

Covers 5 international data integrity frameworks (FDA, EU, MHRA, PIC/S, WHO)

SOP and audit trail review procedure ready for immediate deployment

Want us to assess your data integrity program?

We conduct ALCOA+ gap assessments, audit trail reviews, and Part 11 compliance evaluations across your systems. Deliverables include risk-rated findings and a prioritized remediation roadmap.

Book a Discovery Call

Now Available

21 CFR Part 11 Complete Pack

$299 One-time purchase

Seven audit-ready templates for FDA 21 CFR Part 11 electronic records and electronic signatures compliance. Covers the full Part 11 lifecycle from compliance planning through periodic review, with SOPs for e-records management, e-signatures, and access control. Includes the 11.100(c) certification letter template that most competing packs miss.

Get the Part 11 Pack — $299

Digital delivery via email within 1 business hour during business hours (typically within minutes).

30-day money-back guarantee. If the pack doesn't meet your compliance needs, we'll refund your purchase.

Aligned to 21 CFR Part 11, FDA Scope & Application guidance (2003), E-Records/E-Signatures Q&A (2024), FDA CSA (Feb 2026), and QMSR/ISO 13485:2016.

What's Included

docx

Part 11 Compliance Master Plan

12 sections · Phased implementation · System inventory · Risk classification
docx

Electronic Records Management SOP

8 procedure sections · Creation, modification, backup, retention, retrieval, open systems
docx

Electronic Signatures Policy & SOP

Full Subpart C coverage · Signing session controls · ID/password requirements
xlsx

Part 11 System Assessment Tool

33 assessable criteria · 4 worksheets · Auto-calculating compliance dashboard
docx

Access Control & User Management SOP

Provisioning/deprovisioning · RBAC · Password policy · Periodic access reviews
xlsx

Periodic Compliance Review Template

35 review items across 7 sections · Auto-calculating summary dashboard
docx

FDA E-Signature Certification Letter

Ready-to-print 11.100(c) certification · Current FDA submission address · Tracking form

Why This Pack

Includes the FDA 11.100(c) certification letter most packs miss (frequent 483 citation)

33 assessment criteria covering closed systems and electronic signatures

35 periodic review items for ongoing compliance monitoring

Aligned to 2003 Scope & Application guidance and 2024 E-Records Q&A expansion

All 26 regulatory citations independently verified March 2026

Need help implementing Part 11 compliance?

We conduct Part 11 system assessments, remediate gaps in electronic records and e-signature controls, and prepare organizations for FDA inspection readiness. From gap analysis through closure.

Book a Discovery Call

Now Available

TPS/COTS Fit-for-Use Toolkit

$279 One-time purchase

Six audit-ready templates for vendor qualification, risk classification, and ongoing monitoring of third-party and commercial off-the-shelf software systems. Covers the full vendor lifecycle from intake through periodic review, with auto-calculating risk dashboards and CSA-aligned binary risk mapping. Includes four industry modules: Medical Device/SaMD, Pharma/GMP, Clinical Trials, and AI/ML Systems.

Get the FFU Toolkit — $279

Digital delivery via email within 1 business hour during business hours (typically within minutes).

30-day money-back guarantee. If the toolkit doesn't meet your compliance needs, we'll refund your purchase.

Aligned to FDA CSA (Feb 2026), 21 CFR Part 11, EU GMP Annex 11, EU AI Act (2024/1689), FDA Cybersecurity (Feb 2026), ICH E6(R3), GDPR, and ISO 13485:2016 (QMSR).

What's Included

docx

Vendor/System Intake & Risk Classification Form

12 sections · 4 industry modules (Device/SaMD, Pharma, Clinical Trials, AI/ML) · Part A (stakeholder) + Part B (QA/RA)
docx

Vendor Assessment Questionnaire

77 questions across 8 domains · Per-section scoring · Accept / Conditional / Reject criteria
xlsx

System Risk Classification & FFU Evaluation Tool

6 worksheets · 15 risk factors · 24 FFU criteria · Auto-calculating dashboard
xlsx

Supplier Audit Checklist

103 audit points across 7 domains · 9 worksheets · 112 formulas
docx

Vendor Qualification Summary Report

12 sections with TOC · 5 signature blocks · Full evaluation wrap-up
xlsx

Periodic Vendor/System Review Checklist

43 review items · 20-row incident log · 12 trigger assessment items · 51 formulas

Why This Toolkit

103 audit points covering quality systems, data integrity, security, validation, and regulatory compliance

77-question vendor questionnaire with Accept / Conditional / Reject scoring per domain

Auto-calculating risk dashboard with CSA-aligned binary risk mapping (high / not-high)

Industry-specific modules for medical device, pharma, clinical trials, and AI/ML systems

All 19 regulatory citations independently verified March 2026

Need help with vendor qualification or supplier audits?

We conduct vendor assessments, risk classifications, and fit-for-use evaluations for third-party and COTS software. From initial intake through qualification decision and ongoing monitoring.

Book a Discovery Call

About

Built by a regulatory professional, not a tech startup

Zach Galloway

Founder, RegulatoryIQ

Quality and regulatory affairs leader with 14+ years guiding medical device, pharmaceutical, Software as a Medical Device (SaMD), and clinical trial programs through global regulatory requirements. Hands-on experience leading regulatory and quality operations across FDA, EU MDR, MHRA, TGA, Health Canada, PMDA, ISO 13485, and ICH GCP frameworks.

No critical findings across 60+ completed regulatory and Sponsor/CRO audits
Led quality operations through a $13M digital therapeutics merger, harmonizing QMS processes and maintaining multi-framework compliance
Built SaMD validation frameworks supporting FDA pre-submissions, 510(k), and De Novo applications
Compressed CAPA resolution timelines by 59% and reduced audit findings by 60% through process optimization
Consulting engagements spanning medical device compliance, usability engineering (IEC 62366-1), data integrity risk assessments, QMSR/ISO 13485 mock audits, and QMS buildout for healthcare technology platforms
Combines deep regulatory expertise with AI and machine learning capabilities, including development of this platform

"Every template and assessment is built from hands-on audit experience, not generated by AI and left unreviewed. When you buy from RegulatoryIQ, you're getting the same frameworks I use in real consulting engagements."

RAC Regulatory Affairs Certification – RAPS

CMQ/OE Manager of Quality/OE – ASQ

CPHQ Healthcare Quality – NAHQ

ACRP-CP Clinical Research – ACRP

ACRP-MDP Medical Device Professional – ACRP

Lead Auditor ISO 9001, 13485, 27001

LSSBB Lean Six Sigma Black Belt

RIMS-CRMP Certified Risk Management

AiE AI Engineer – ARTiBA

GCP ML Google Cloud Prof. ML Engineer

AWS ML AWS Machine Learning, Specialty

AIGP AI Governance Professional – IAPP

Advisory Services

Regulatory Advisory Services

Need more than templates? Work directly with a certified regulatory professional on your specific compliance challenges.

Gap Assessment Review

Have your gap assessment findings reviewed by an experienced auditor. Get a prioritized remediation roadmap with risk-rated action items and realistic timelines.

Scope: 2-4 hour engagement

Ideal for: Organizations preparing for FDA, EMA, or MHRA inspections

FDA 21 CFR Part 11 · ISO 13485 · EU MDR · ICH E6(R3) · ALCOA+

QMS & Compliance Consulting

From QMSR transition planning to SaMD classification, get hands-on guidance from someone who has done it.

Scope: Project-based or retainer

Ideal for: Pharma, biotech, and medical device companies navigating regulatory transitions

QMS buildout · CSV/CSA · Vendor qualification · Design controls · CAPA · Audit prep

Mock Audit & Inspection Readiness

Know what an auditor will find before they find it. Mock audits modeled on real FDA, Notified Body, and Sponsor/CRO audit approaches.

Scope: 1-3 day engagement

Ideal for: Companies expecting inspections within the next 6 months

Track record: No critical findings across 60+ completed audits

Typical response within 1 business hour. Initial 15-minute scoping calls are complimentary.

Prefer to book directly? Schedule a Discovery Call

Questions

Frequently asked questions

What format are the templates in?

Assessment checklists are in Excel (.xlsx) with structured worksheets, dropdown selections, and built-in scoring. Implementation templates (Remediation Plan, Executive Summary) are in Word (.docx) with professional formatting and regulatory reference tables.

Are these updated for the 2026 QMSR transition?

Yes. The toolkit includes a dedicated QMSR / ISO 13485:2016 Gap Assessment with 100 criteria, a transition readiness checklist, and a full 820-to-ISO 13485 clause mapping reference. All other templates also reflect the QMSR final rule effective February 2, 2026, the FDA CSA guidance (February 3, 2026), and ICH E6(R3) finalization. Every regulatory citation was verified against current published versions in February 2026.

Can I use these across multiple sites or facilities?

Yes. Templates are delivered as editable files with no DRM or usage restrictions. Use them across as many sites, projects, or audits as needed within your organization.

Who built these templates?

RegulatoryIQ templates are developed by Zach Galloway, a certified regulatory and quality professional (RAC, CMQ/OE, CPHQ, LSSBB, Lead Auditor) with 14+ years of hands-on experience across FDA, EU, and ISO compliance frameworks. Every template reflects the same methodologies used in real consulting engagements.

What if I find an error in a regulatory citation?

We stand behind our accuracy. If you identify an incorrect or superseded citation, contact us and we'll issue a corrected version within 48 hours.

Is there a refund policy?

Yes. We offer a 30-day money-back guarantee. If the toolkit doesn't meet your compliance needs, contact for a full refund.

Do you offer consulting services?

Yes. We offer gap assessment reviews, QMS and compliance consulting, and mock audit/inspection readiness engagements. Contact for a complimentary 15-minute scoping call.

Find compliance gapsbefore your auditor does

AI Gap Analysis

How It Works

What You Get

The cost of finding gaps late

Current as of March 2026

FDA Computer Software Assurance

QMSR / 21 CFR Part 820 Transition

ICH E6(R3) Good Clinical Practice

What FDA is actually citing in 2024-2026

Top finding categories in QSR & BIMO letters

FDA Inspection Intelligence

Six pillars of compliance intelligence

Regulatory Document Review

Third-Party Software (TPS) / COTS Fit-for-Use Assessment

Gap Assessment & Remediation

QMSR Transition Support

SaMD & Clinical Trial Support

Data Integrity & Security

Gap Assessment Toolkit

What's Included

Why This Toolkit

CSV/CSA Package

What's Included

Why This Package

Data Integrity Pack

What's Included

Why This Pack

21 CFR Part 11 Complete Pack

What's Included

Why This Pack

TPS/COTS Fit-for-Use Toolkit

What's Included

Why This Toolkit

Built by a regulatory professional, not a tech startup

Regulatory Advisory Services

Gap Assessment Review

QMS & Compliance Consulting

Mock Audit & Inspection Readiness

FDA 21 CFR Part 11 Quick Assessment

Frequently asked questions

AI-Powered Compliance Platform

40+ regulatory frameworks

Ready to streamline your compliance?

Find compliance gaps
before your auditor does