Writing Validation Master Plans (VMPs) for Pharmaceutical Drug Manufacturing
A Validation Master Plan (VMP) serves as a high-level, strategic document that provides a comprehensive roadmap for validation activities…
Ensuring Data Integrity & Equipment Qualification per 21 CFR Part 11
Common Challenges in Data Integrity 1. Deletion of Audit Trails During recent qualification efforts for a depth filtration skid…
ISO 9000:2015 & ISO 9001:2015
ISO 9000:2015 and ISO 9001:2015 are pivotal standards in quality management systems (QMS), setting the benchmark for excellence across…
Elevating Cell and Gene Therapies – The Latest in Validation Innovation
Elevating Cell and Gene Therapies – The Latest in Validation Innovation, our comprehensive whitepaper designed to illuminate the forefront…
Demystifying CQV – Essential Insights for Compliance
The Commissioning, Qualification, and Validation (CQV) whitepaper presents a strategic approach to ensuring systems, processes, and equipment integrity and…
CSV Vs CSA – Unpacking FDA’s Revised Software Validation
Embrace cutting-edge innovation in Quality Assurance (QA) through a comprehensive understanding of Computer System Validation Vs. Computer System Assurance…
