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The Practical Solutions Group, LLC
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Princeton, NJ 08542
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Articles and Opinions

Three things you need to know about 21 CFR part 11
GxP Perspectives

Quantifying Quality for GxP Compliance
GxP Perspectives

Another tool for your survival kit
enKap for An Exclusive Learning Community

Effective Responses to Avoid Warning Letters
GxP Perspectives

Standard – 21 CFR part 11
Standards.org

GxP Audit Techniques & Etiquette
GxP Perspectives

GxP Quality – Building a Culture of Compliance
GxP Perspectives

How FDA will enforce 21 CFR part 11
GxP Perspectives

The “Business” of Investigations
The Journal of GXP Compliance

The “Business” of Outsourcing
Pharmaceutical Canada

Expect More From Your Quality Assurance Group
Journal of GXP Compliance

Part 11 Business Case Should Drive Smart Compliance Efforts
Edata Integrity Report

Auditing for Business Risks in the World of Regulatory Compliance
Journal of GXP Compliance

The “Business” of Risk Assessment in the World of Computer System Validation
Journal of GXP Compliance

The ‘Business’ of Quality Assurance
Quality Assurance Journal

A Case Study Approach: 21 CFR Part 11 and Common Sense: Do they Co-Exist?
Journal of GXP Compliance

21 CFR Part 11: Electronic Records; Electronic Signatures; Electronic Copies of Electronic Records
Journal of GXP Compliance

21 CFR Part 11: Electronic Records, Electronic Signatures: Questions and Answers
Journal of GXP Compliance

Conducting Effective Validations of Computer-Related Systems: How Much is Enough?
Journal of Validation Technology

Conducting an Internal Audit for Electronic Records Compliance: A Primer
Journal of cGMP Compliance

Expert Examines Key Requirements for Computerized Clinical Study Systems
Guide to Good Clinical Practice

Controlling the Electronic Transfer of Clinical Trial Data: Practical Advice
Journal of cGMP Compliance

Remaining in a 21 CFR Part 11 Compliant State
Journal of cGMP Compliance

Do It Right the First Time: A Handbook for Controlling Technology Through Good Validation Practices
Journal of Validation Technology

Controlling the Impact of Technological Change Through Good Validation Practices
Regulatory Affairs Focus

Mission Impossible? Developing a Practical Validation Strategy
The Compliance Advisor

The Relationship of Validation to Quality Management in the System Development Life Cycle
The Compliance Advisor

Having Validated and Unvalidated Software in a Production Environment
The Compliance Advisor

FDA Certificate of Appreciation

Is This the Future?