Audit, Inspection & Evidence
Audit and inspection readiness, evidence management, audit trails and compliance document review.
26 articles
- AI Document Compliance Checker: How to Choose One You Can Defend to an Auditor GenAI use in professional firms nearly doubled to 40%. Learn how to pick an AI document compliance checker with cited evidence an auditor can verify.
- FDA 483 Response Checklist: How to Answer Observations in 15 Business Days Respond to an FDA 483 within 15 business days and FDA reviews it before deciding on a warning letter. Use this 2026 checklist and avoid common mistakes.
- GMP Data Integrity Checklist: ALCOA+, Audit Trails and 2026 Expectations 15% of 2025 FDA drug warning letters cited data integrity. Use this GMP data integrity checklist based on FDA, MHRA and the 2025 EU Annex 11 draft.
- 21 CFR Part 11 Audit Checklist: Electronic Records and Signatures in 2026 A clause-by-clause 21 CFR Part 11 audit checklist covering controls, audit trails and e-signatures, plus FDA's enforcement discretion and 2026 updates.
- ISO 13485 Internal Audit Checklist: QMSR-Ready for 2026 FDA can now read your internal audit reports. Use this QMSR-ready ISO 13485 internal audit checklist, aligned with FDA's six inspection areas and ISO 19011:2026.
- Medical Device Audits in 2026: Internal, Supplier, Notified Body and MDSAP Internal, supplier, notified body and MDSAP audits explained, plus what QMSR and ISO 19011:2026 change for medical device audit programs.
- FDA Medical Device Inspections in 2026: What to Expect Under QMSR How FDA inspects device makers under QMSR and CP 7382.850: inspection types, the six QMS areas, 483s, remote assessments and a readiness checklist.
- Medical Device Documentation and Documentation Review: A 2026 Guide What documentation FDA and the EU MDR require for medical devices in 2026, and a practical method and checklist for reviewing it before auditors do.
- FDA Form 483 Explained: What It Means, Top Observations and How to Respond What an FDA Form 483 means, the most-cited observations for drugs and devices in FY2025, early QMSR findings, and how to write a response within 15 business days.
- FDA Warning Letters in 2026: Trends, Triggers and How to Respond FDA warning letters surged in 2025 and 2026 brought the first AI and QMSR letters. What triggers a warning letter, how to respond and how to get a close-out.
- FDA Inspections in 2026: Types, What to Expect and an Inspection Readiness Plan FDA inspections are more frequent, more unannounced and more data-driven. Inspection types, what happens on site, outcomes and a practical readiness plan.
- ISO 13485 Audit and Gap Analysis: Certification Audits, MDSAP and a Clause-by-Clause Checklist How ISO 13485 certification and MDSAP audits work, how to run a gap analysis now that FDA's QMSR cites ISO 13485, and a clause-by-clause checklist.
- CAPA Audit and Effectiveness Checks: How to Prove Your CAPA System Works How auditors and FDA investigators evaluate a CAPA system, how to design effectiveness checks that prove actions worked, and a CAPA audit checklist.
- Design Control Audits and Design Documentation Review: A Practical Guide for Medical Device Teams How FDA, MDSAP and internal auditors audit design controls in 2026, how to run design documentation reviews, and a design control audit checklist.
- GxP Compliance: What GMP, GLP, GCP and GDP Require and How to Stay Compliant What GxP compliance means across GMP, GLP, GCP and GDP, the 2025-2026 updates (ICH E6(R3), EU Annex 11 and 22, DSCSA) and a compliance checklist.
- GMP Compliance and GMP Inspections: What FDA Investigators Look For in Drug Facilities How FDA inspects drug and API facilities for GMP compliance: the six-system model, full vs abbreviated inspections, top 2025 citations and a checklist.
- GMP Audits: How to Plan and Run Internal, Supplier and Mock Inspection Audits How to plan and run GMP audits: self-inspections, supplier and CMO audits, and mock FDA inspections, with the six-system scope and a checklist.
- GMP Documentation: Records, ALCOA+ and the Documentation Errors FDA Cites Most What GMP documentation drug makers must keep under 21 CFR 211, ALCOA+ data integrity, the 2025 EU Chapter 4 draft and the documentation errors FDA cites.
- Batch Record Review: A GMP Guide to Reviewing Batch Documentation for Compliance How to review batch records under 21 CFR 211.192, ICH Q7 and EU GMP: who reviews, what to check, deviations and audit trails, and the gaps FDA cites.
- Regulatory Compliance Management for Life Sciences: Building a System That Holds Up How life sciences companies manage regulatory compliance as a system: obligations registers, controls, monitoring, inspection readiness and evidence.
- Supplier Audits: Planning, Conducting and Following Up, With Software Options How to plan and run supplier audits in pharma and devices: risk-based frequency, scope, reports, follow-up, the QMSR change on audit reports, and software.
- Supplier Compliance and Document Review: What to Check and How Often What supplier compliance means in pharma and devices, which supplier documents to review, how to verify certificates of analysis and keep files current.
- What Is GRC? Governance, Risk and Compliance Explained What GRC means, how governance, risk and compliance fit together, the frameworks behind it, the 2026 drivers and how to build an evidence-based program.
- GRC Software and Compliance Management Software: What It Does and How to Choose What GRC and compliance management software does, which modules matter, what GRC automation can and cannot do, and what to ask before you buy in 2026.
- NIST Assessment Guide: NIST 800-171 Self-Assessment, CMMC and Security Control Assessments Which NIST assessment you need: SP 800-171 self-assessments and CMMC (Phase 2 from November 10, 2026), SP 800-53A control assessments and evidence.
- ISO 27001 vs SOC 2 Assessment: Choosing a Security Compliance Assessment How ISO 27001 certification and SOC 2 examinations differ, what each involves, where FedRAMP fits, and how to prepare evidence once for several frameworks.
Subjects covered
- audit management software
- audit automation
- AI audit
- compliance audit
- internal audit software
- internal audit automation
- audit readiness
- inspection readiness
- audit evidence management
- compliance evidence management
- evidence collection automation
- audit documentation