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Feb 3, 2026
A Structured CQV Project Timeline Ensuring Seamless Validation from URS to PQ
In today’s regulated pharmaceutical and biotech environments, project ...
Read moreJan 27, 2026
Risk Management Updates & What They Mean for QA
The revision of ICH Q9(R1) represents one of the most significant global...
Read moreJan 2, 2026
Quality as Operations Strategy
The life science industry is undergoing a strategic shift: Quality is no...
Read moreDec 10, 2025
The Strategic Value of Effective Audit Reporting
Audit reports play a pivotal role in governing the quality and regulator...
Read moreAug 22, 2025
Top 10 FDA Audit Issues
In the world of FDA-regulated industries, few events evoke more anxiety ...
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May 21, 2025
Technical Evaluations as Risk Assessments
Risk assessments help companies follow regulations, maintain product quality, and protect ...
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Mar 31, 2025
Active Pharmaceutical Ingredients: Vulnerabilities and Considerations
Historical trends have shown that the strategies for supplying APIs are inherently dynamic, influe...
Read moreRegulatory Series
White Paper
Mar 4, 2025
Transition to Paperless Validation
Traditional validation in the life sciences industry has long depended on paper-based syst...
Read moreRegulatory Series
White Paper
Jan 28, 2025
Writing Validation Master Plans (VMPs) for Pharmaceutical Drug Manufacturing
A Validation Master Plan (VMP) serves as a high-level, strategic document that provi...
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