Clause-level gap assessments and audit-ready templates built by a certified regulatory professional with 14+ years of hands-on audit experience. Covering FDA, ICH, EU MDR, ISO 13485, and 40+ frameworks globally.
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.
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.
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.
Upload your documentation and receive instant gap analysis against any supported regulatory framework. Identifies non-conformities, maps requirements to evidence, and prioritizes findings by risk.
21 CFR Part 11 · ISO 13485 · EU MDRGAMP 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 QualificationAutomated 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 · ActionableAutomated monitoring of FDA, ICH, EMA, MHRA, ISO, and IEC updates. Receive notifications when guidance changes affect your compliance posture, with impact assessments and recommended actions.
FDA · ICH · EMA · MHRA · ISO · IECIMDRF 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 14155ALCOA+ 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 TrailsTotal 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.
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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.
"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."
Have your gap assessment findings reviewed by an experienced auditor. Get a prioritized remediation roadmap with risk-rated action items and realistic timelines.
From QMSR transition planning to SaMD classification, get hands-on guidance from someone who has done it.
Know what an auditor will find before they find it. Mock audits modeled on real FDA, Notified Body, and Sponsor/CRO audit approaches.
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