Data Integrity Matters | Unjustified Invalidation of Orphan Data
September 22, 2017|

Orphan data may exist for any number of scientific or operational reasons, but in today’s environment – until the regulators trust the companies again – each piece of orphan data is suspect and may contain evidence of data tampering. So can you delete it?

Data Integrity Matters | The Human Factors
August 25, 2017|

3 signs that you need to create a culture of compliance As mentioned in my first post on data integrity, people trust that companies create safe, quality products and rely on data to support that belief. But most product data, especially laboratory testing, should be designed to catch studies, batches, or test samples that fail…

Data Integrity Matters | Why is Data Integrity a Hot Topic Now?
June 30, 2017|

What can happen when a laboratory doesn’t know that its electronic records leave a digital trace that the FDA can follow.

Data Integrity Matters | Why is Data Integrity Important?
May 10, 2017|

Behind analytical data are humans – with pressures, emotional and personal needs to provide the best possible data for the biggest impact, personal pride, or simply a desire to make their lives easier. Do human or cultural factors affect scientists in regulated laboratories or operators in manufacturing areas?

man looking at computer

Data Integrity Matters | Introduction
March 30, 2017|

It’s not just about compliance any more. You’ve seen it in the headlines: 79% of Warning Letters issued by the FDA cite data integrity issues in 2016 (up from just 26% in 2013). But what does this actually mean? Where do these figures come from? Isn’t this just in India or China? What was traditionally…