Insight and opinion

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…

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…

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