Insight and opinion
9 Reasons Why You Should Choose Cloud-Based Validation
Kneat Gx, our innovative software-as-a-service (SaaS) digital validation solution, resides in a secure cloud environment that leverages automation for rapid…
3 Key Skills for Validation Professionals in 2022
Learning new skills that your organization needs to thrive and succeed today also gives you the potential to progress within…
How Does Your Validation Program Measure Up?
Launching in 2022, the State of Validation is an annual report, powered by Kneat Solutions, comprising primary research conducted with…
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 will be at risk of ‘discord’ – a state whereby a validation work process is performed differently, at different sites at the same time.
25 Years of CFR Part 11
After being enacted on August 20, 1997, the regulation which determines the validation and compliance of electronic systems continues to…
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…
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…
The Environmental Impact of Validation
What is the environmental impact of validation? At any one time, a large global pharmaceutical company will archive and…
Data integrity, an increasing regulatory focus
The life sciences industry generates a massive volume of complex data. As companies embrace automated systems and cloud storage solutions,…
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. Global regulatory authorities have increased their inspection focus to ensure good Data Integrity practices are being implemented. The increased focus results from inspection observations of significant deficiencies.
Top 5 Reasons IT Projects Fail
And What Project Leaders Need to Know to Prevent it Statistics suggest that upwards of 75% of major IT projects…
Managing Value Through Lean Validation
Part two of the two-part ‘Lean Validation’ series, “Managing Value Through Lean Validation” explores the management of value-added and non-value-added…
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