Deviation, Change Control & Validation
Deviation investigation, change impact assessment, computer system validation and process validation.
18 articles
- 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.
- GMP Deviation Investigation Checklist and Template for Pharma QA 21 CFR 211.192 was FDA's #2 drug citation in FY2025. Use this deviation investigation checklist and template to find real root causes, not "human error."
- GMP Change Control Impact Assessment: A Practical Guide for Pharma Assess GMP changes for quality, validation and regulatory impact. Covers 21 CFR 211.100, 314.70 reporting categories, ICH Q10 and Q12, with a template.
- Medical Device Change Impact Assessment: When Do You Need a New 510(k)? Not evaluating changes is a possible OAI finding under QMSR. Learn how to assess device changes, decide on a new 510(k) and use PCCPs in 2026.
- Process Validation: The Three Stages, What FDA and EU Expect, and Common Gaps What process validation means under FDA's lifecycle guidance and EU Annex 15, what each stage requires, and the gaps FDA cited in 2026 warning letters.
- Change Control in GMP: Process, Requirements and How to Make It Work How GMP change control works: the steps, what 21 CFR 211, ICH Q10, EU Annex 15 and ISO 13485 require, reporting categories and mistakes inspectors cite.
- Change Impact Assessment: How to Assess a GMP Change Before You Approve It How to assess the impact of a GMP change: what to cover, how ICH Q9(R1) shapes the risk assessment, revalidation and filing decisions, with a template.
- Computer System Validation (CSV) in 2026: From GAMP 5 to FDA's Computer Software Assurance What computer system validation requires under 21 CFR 211.68, Part 11 and EU Annex 11, how GAMP 5 and FDA's 2025 CSA guidance change it, and FDA findings.
- Change Control Software: What It Must Do, How to Validate It and How to Choose What GMP change control software must do, the Part 11 and Annex 11 controls it needs, risk-based validation and the questions to ask vendors.
- Medical Device Automation: Validating Automated Manufacturing and QA Under QMSR Automating medical device production or QA? How QMSR and FDA's 2026 CSA guidance shape validation, plus a step-by-step automation roadmap.
- CAPA Root Cause Analysis and Investigations: Methods, Pitfalls and What FDA Expects How to run a CAPA investigation that finds the real root cause: methods like 5 Whys, fishbone and FMEA, the human error trap, and what FDA warning letters reveal.
- Design Control Software and DHF Automation: What to Automate and How to Validate It What design control software should automate under the QMSR, where AI helps, how to validate tools under FDA's CSA guidance, and a selection checklist.
- Pharmaceutical Manufacturing in 2026: Onshoring, Advanced Manufacturing and What FDA Expects Pharmaceutical manufacturing in 2026: Section 232 tariffs, FDA PreCheck, advanced manufacturing designations and the GMP work new US plants need.
- 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 and GxP Software: Validation, Data Integrity and Automation in 2026 What GMP and GxP software must do, how to validate it for FDA and the draft EU Annex 11, data integrity controls, and where automation and AI fit.
- Electronic Batch Records (EBR): What They Are, What Regulators Expect and How to Implement Them What an electronic batch record is, what 21 CFR 211 and Part 11 require, how EBR review works, and how to plan an EBR rollout that inspectors accept.
- Review by Exception: How Exception-Based Batch Record Review Works and When It Is Acceptable What review by exception means for batch records, the prerequisites regulators expect, how to justify it in validation, and mistakes that cause findings.
- Batch Release Software and Batch Record Review Automation: What to Automate and How to Validate It Buyer's guide to batch release and batch record review software: what to automate, Part 11 and Annex 11 controls, CSA validation and vendor questions.
Subjects covered
- deviation management
- deviation management software
- deviation investigation
- GMP deviation
- deviation assessment
- deviation automation
- quality event management
- quality event management software
- change control
- change control software
- change impact assessment
- change control assessment