Practical guidance on pharmaceutical CSV, QA, data integrity, and regulatory compliance - written by PHARPRO's consulting team.
Subscribe via RSSPHARPRO DVS is AI validation lifecycle software with 30 document builders from URS to VSR - compared to manual Word/Excel approaches, reviewed for FDA 21 CFR Part 11 and EU GMP Annex 11 compliance.
Read article →50 questions your QA team should answer before any FDA, EU GMP, or national authority inspection. Print-ready and free.
Get the checklist →AI-powered DVS-PQR Module cuts Product Quality Review time by 91%, full GAMP 5 & EU GMP Annex 11 validation project completed, thermal mapping training launched in Pakistan, and 12+ pharma clients served this month.
Read the full update →Comprehensive two-day Good Manufacturing Practice training: regulatory frameworks, quality systems, data integrity, deviation management, CAPA, GMP inspection readiness & real case studies. Online & in-person. Limited seats.
Read article & register →Two-day hands-on CSV training: GAMP 5 risk model, IQ/OQ/PQ protocol writing, data integrity, EU GMP Annex 11, and a full case study. Limited to 20 seats - register now.
Read article & register →What ISPE GAMP 5 Second Edition means for your validation programme - new three-category risk model, critical thinking principles, cloud system guidance, and what to update in your existing documentation.
Read article →A practical checklist covering every major area EU GMP inspectors assess - supplier qualification, validation documentation, audit trails, access controls, change control, and periodic review.
Read article →How to build an effective CAPA system - root cause analysis, corrective actions, effectiveness checks, and what FDA and EU GMP inspectors expect to see in your CAPA records.
Read article →Received an FDA Warning Letter? How to structure your response, address observations correctly, avoid common mistakes, and restore regulatory standing step by step.
Read article →A practical guide to qualifying pharma suppliers - the risk-based approach, audit checklist, quality agreements, and ongoing monitoring requirements under EU GMP Chapter 5 and FDA 21 CFR.
Read article →How to validate SaaS and cloud-hosted GxP systems - GAMP 5 category classification, vendor qualification, data integrity controls, and change management for vendor-initiated updates.
Read article →How to prepare your pharmaceutical site for an FDA, EU GMP, or national authority inspection - documentation review, data integrity checks, staff briefing, and mock audits.
Read article →What a VMP must contain, who approves it, how it links to your validation programme - and the common gaps regulators find in Validation Master Plans during EU GMP and FDA inspections.
Read article →System-level and functional risk assessment for computerised systems - GAMP 5 categories, risk-based testing, and how to document your risk rationale in an audit-ready format.
Read article →How to build and maintain a training matrix, what records regulators require, and the most common GMP training findings that lead to inspection observations - and how to avoid them.
Read article →Electronic records, audit trails, electronic signatures, and access controls - exactly what 21 CFR Part 11 requires, and the seven compliance gaps that most commonly generate FDA warning letters.
Read article →Our consultants answer practical compliance questions - no sales pitch, just straight answers.
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