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