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Active Pharmaceutical Ingredients: Vulnerabilities and Considerations
Historical trends have shown that the strategies for supplying APIs…
Transition to Paperless Validation
Traditional validation in the life sciences industry has long depended…
Writing Validation Master Plans (VMPs) for Pharmaceutical Drug Manufacturing
A Validation Master Plan (VMP) serves as a high-level, strategic…
Ensuring Data Integrity & Equipment Qualification per 21 CFR Part 11
Common Challenges in Data Integrity 1. Deletion of Audit Trails…
ISO 9000:2015 & ISO 9001:2015
ISO 9000:2015 and ISO 9001:2015 are pivotal standards in quality…
ICH Q14- Analytical Procedure Development
ICH Q14, on analytical procedure development, is set to revolutionize…
Equipment Validation: A Comprehensive Overview
The pharmaceutical industry involves various steps and procedures in drug…
Fortify Your Systems: The Power of Validation & Support
Validating computer systems and ensuring robust IT infrastructure support is…
ALCOA+ Principles – The Backbone of Data Integrity
Data integrity is data’s accuracy, completeness, consistency, and validity throughout…
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