25 years of CFR Part 11
Uncover the essentials of FDA's 21 CFR Part 11 regulation for life sciences: its impact on electronic records, compliance, and....
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Top 10 validation challenges for life sciences SMBs in 2022
Top 10 validation challenges for life sciences SMBs in 2022
3 validation trends to watch in 2022
In this article we outline three key emerging validation trends to watch in 2022.
The environmental impact of validation
What is the environmental impact of validation? At any one time, a large global pharmaceutical company will archive and store....
Data integrity, an increasing regulatory focus
Discover the critical role of data integrity in regulatory compliance through our detailed article. It highlights the intensified regulatory focus....
How paperless validation systems support data integrity
Data Integrity is a major concern for the global pharmaceutical and medical device industries, across many of their business areas.....
Top 5 reasons IT projects fail
Statistics suggest that upwards of 75% of major IT projects fail. They are considered failures because they did not deliver....
Managing value through lean validation
Companies need to determine whether each step or process in their validation process adds value, or whether it is a....
Lean validation in GxP organizations
Becoming known as the ‘Toyota Production System, this ‘Just in Time’ approach to inventory management provided inventory per production demand.