Insight and opinion

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 store…

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…

Lean Validation in GxP Organizations

Part one of the two-part ‘Lean Validation’ series, “Achieving Lean Validation in GxP Organizations” explores Lean, it’s origins and how…

How Kneat’s SaaS platform is empowering customers through COVID-19

COVID-19 has become a stark reminder of the threat pandemics pose to the continuity of critical industries and the vital…

What Is Computer Software Assurance (CSA) and Why Is the FDA Transitioning From Traditional Computer System Validation?

The FDA’s new approach, Computer Software Assurance (CSA), represents a significant paradigm shift and places critical thinking at the centre of the CSV process, as opposed to a traditional almost one size fits all approach.

10 Trailblazing Women in Tech History

Technology is often cited as an industry with low equality in employment gender representation, a trend that trailblazing women have …

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