Heather Longden
Heather Longden
After a number of years in training, supporting and selling Waters Software, Heather's current role is as a specialist in compliance to e-record regulations, acting as a resource to the global informatics community at Waters and the users of all Waters informatics products. This involves helping design the compliance into our informatics products and services, attending and presenting at specialist conferences, keeping up to date on the latest interpretations and amendments to the regulations and disseminating this information to the Waters field and corporate organizations. Heather is also active in the ISPE GAMP Community of Practice and the ISPE New England Chapter where she is called on as an expert in Data Integrity, specifically around the chromatographic analysis process.

Posts by author

Data Integrity Matters | Unjustified Invalidation of Orphan Data

By 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?

Categories: Data Integrity
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Data Integrity Matters | The Human Factors

By 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… Read more >

Categories: Data Integrity
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Data Integrity Matters | Why is Data Integrity a Hot Topic Now?

By 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.

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Data Integrity Matters | Why is Data Integrity Important?

By May 10, 2017

Definition: Da·ta In·teg·ri·ty Data provides the evidential support that a hypothesis is true or false. This might be a hypothesis that an academic theory can be proved, that food is safe for consumption, that water is… Read more >

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Data Integrity Matters | Introduction

By 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… Read more >

Categories: Data Integrity
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