Author
Michael J. Gregor
Founder & CEO of compligen.AI. 37+ years leading FDA regulatory compliance, computer system validation (CSV), computer software assurance (CSA), and data integrity across 100+ pharma, biotech, medical device, and clinical research engagements. Contributor to the FDA’s Computer Software Assurance guidance process. 75+ industry publications.
Articles by Michael
From CSV to CSA: What Life Sciences Companies Need to Know in 2025 & Beyond
Real innovation isn't just about keeping up — it's about choosing what truly matters for patient safety and business growth.
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Software Validation in Life Sciences: Expert Guide to Keep Your Systems Audit-Ready
Software validation ensures systems work as intended and meet regulator expectations — protecting quality, data integrity, and release timelines.
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7 Critical Data Integrity Mistakes Life Sciences Companies Make (and How to Fix Them Before FDA Inspections)
The seven most frequent data integrity errors life sciences companies commit — and how to resolve them before an FDA inspection finds them first.
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Tackling Data Integrity Gaps: FDA Remediation Tips for Biotech Quality Managers
Data is the heartbeat of biotech, but if it's not trustworthy, it's just clutter. Practical ways to close the gaps before an inspection finds them.
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Building a Validation Master Plan (VMP) for CSV: Essential Steps and Common Pitfalls to Avoid
A plan is not just a list. It's what guides everyday work and makes sure small details don't become big problems.
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Outsourcing Internal Audits in Life Sciences: A Game-Changer for Compliance and Innovation
Compliance done right clears the path for progress — because confidence beats rework every time.
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Driving Compliance in BioTech with Data Integrity Programs
When data is right, work flows right. Strong data practices cut noise, speed decisions, and keep inspectors satisfied.
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CSV vs. CSA: Mastering Device Development for MedTech Firms
In MedTech, real progress comes when you simplify the process without losing focus on patient safety and product quality.
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Secrets to 21 CFR Part 11 Success with Data Integrity Services, CSV, and GAMP 5 Guidelines
Blending data integrity services, Computer System Validation, and GAMP 5 into one compliance strategy that is strong, simple, and fits your needs.
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Mastering 21 CFR Part 11, Annex 11, and ALCOA+ Principles in the Life Science Industry
A roadmap that is easy to follow, rooted in daily work, and built to help you get from confusion to clarity on Part 11, Annex 11, and ALCOA+.
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Top Mistakes to Avoid with FDA Software Validation and CSA in the Life Science Industry
Quality is not an act, it's a habit. The six slip-ups that turn validation into a paperwork trap — and how to steer clear of each.
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Smart Compliance Strategies for Growing MedTech Firms: How to Be CSV Audit Ready & Embrace CSA?
With the right approach, compliance becomes your secret weapon for growth instead of a headache.
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From CSV to CSA: Cloud-Based Software Assurance for Efficient, Risk-Based Validation
A fresh, smart way to make sure your software works right — without the late nights buried in paperwork.
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Why is a CSA Approach Advantageous for the Life Science industry? Thoughts?
Like building a house — you tackle the foundation and roof, not every nail. That is CSA in a nutshell.
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The Role of Data Integrity Programs and Assessments in Life Sciences QA
In life sciences, trust comes from reliable data. When lives are on the line, every detail counts.
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How to Build Robust Data Integrity Programs and Assessments for FDA Remediation
Data is the backbone of trust in life sciences. Keeping it accurate and secure isn't just a rule — it's a promise to patients.
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Data Integrity Services, Computer Software Assurance, and Compliance Auditing for Startup Growth and Audit Readiness
Compliance doesn't hold you back — it lifts you up. How startups turn regulatory groundwork into a growth booster.
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Computer System Validation vs. Computer Software Assurance: What's the Difference and Why It Matters
What exactly differentiates CSV from CSA? Are they replacing each other? And why is CSA gaining traction now?
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