How does your validation program measure up?
Discover how to evaluate and enhance your validation program with our insightful article. It provides a comprehensive approach to assess....
Resources
Resource center
Subscribe for updates
Featured
Resources
Apply ISPE validation guidance
The ISPE Baseline Guide 5 (Second Edition) provides ‘best of the best’ practical guidance on the implementation of a science....
60 minutes
Sarah Grogan
Fujirebio Diagnostics, Inc uses Kneat to provide CSV at scale
Fujirebio Diagnostics cut CAPA change control time in half and is saving 40% on test script execution, translating to significant....
Process ‘discord’: how validation processes change in isolation, and what you can do to prevent it
Without a built-for-purpose validation system in place to standardize validation work processes across a global organization’s manufacturing sites, that process....
Improved productivity and reduced costs
A growing niche Contract Research Organization with operations in Europe and North America sought to implement a validation solution that....
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....
Top 10 validation challenges for life sciences SMBs in 2022
We surveyed medium sized pharmaceutical and biotechnology companies in the United States and Europe to uncover their top ten validation....
Overcoming SMB validation challenges
To better understand the validation challenges of medium sized companies, we surveyed a group of pharmaceutical and biotechnology organizations in....
3 validation trends to watch in 2022
Each new year brings many new opportunities and challenges for validation and quality professionals across the life sciences sector. 2022....