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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...
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White Paper
Mar 4, 2025
Transition to Paperless Validation
Traditional validation in the life sciences industry has long depended on paper-based syst...
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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 provides a ...
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White Paper
Nov 13, 2024
Ensuring Data Integrity & Equipment Qualification per 21 CFR Part 11
Common Challenges in Data Integrity 1. Deletion of Audit Trails During recen...
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White Paper
Jul 2, 2024
ISO 9000:2015 & ISO 9001:2015
ISO 9000:2015 and ISO 9001:2015 are pivotal standards in quality management systems (QMS),...
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Mar 11, 2024
Elevating Cell and Gene Therapies – The Latest in Validation Innovation
Elevating Cell and Gene Therapies – The Latest in Validation Innovation, our comprehensi...
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Feb 21, 2024
Demystifying CQV – Essential Insights for Compliance
The Commissioning, Qualification, and Validation (CQV) whitepaper presents a strategic app...
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Jan 9, 2024
CSV Vs CSA – Unpacking FDA’s Revised Software Validation
Embrace cutting-edge innovation in Quality Assurance (QA) through a comprehensive understa...
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