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

Traceability in OneLab: Protocols Designed by the Expert Analyst

By August 11, 2020

Typically, expert staff in a lab will be responsible, along with Quality Assurance, to design and document a standard operating procedure (SOP) for other analysts to follow for routine sample preparation tasks. These procedures are key for repeatability and accuracy… Read more >

Categories: Automation
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Traceability in OneLab: Tracking the Analyst’s Completion of an Experiment

By August 7, 2020

Bringing increased confidence to sample preparation workflows using automation, smart laboratory tools and electronic documentation for recording analyst activities Laboratory employees appreciate the importance of traceability in their analytical work, whether to simply check for quality, or for… Read more >

Categories: Automation
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The Impact of Complex Global Supply on the Nitrosamine Crisis

By July 9, 2020

When a crisis occurs, hindsight is a great teacher. Any company developing or manufacturing products that impact human health can learn from the recent nitrosamine impurity contamination of angiotensin II receptor blockers (ARBs) by reviewing… Read more >

Categories: Pharmaceutical
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Data Integrity Matters: Unknown, Unintegrated or Undetected Chromatography Peaks

By March 24, 2020

In an earlier blog, I discussed the concerns about extraneous peaks that might appear in LC separations. While there can be many sources for peaks unrelated to the test substances, how do you decide which… Read more >

Categories: Data Integrity
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Data Integrity Matters: Limiting Access to Tools That Could Be Used to Manipulate Data (Part 4)

By October 8, 2019

Suppressing Peak Integration Being able to optimize peak integration and identification, whether by resetting the method RT settings, manually identifying peaks or suppressing integration of specific known peaks are certainly tools which, in the wrong… Read more >

Categories: Data Integrity

Data Integrity Matters | Limiting Access to Tools That Could Be used to Manipulate Data (Part 3)

By January 14, 2019

How do data integration and reintegration affect data integrity?

Categories: Data Integrity
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Data Integrity Matters | Limiting Access to Tools That Could Be Used to Manipulate Data (Part 2)

By November 5, 2018

What procedures can an analyst use to ensure that a chromatography system is ready to begin analyzing samples, without the fear that the system suitability tests would immediately fail?

Categories: Data Integrity
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Data Integrity Matters | What do you do with Orphan Data Created during Data Acquisition?

By July 19, 2018

Halting a chromatographic analysis where the system is not performing correctly or when another error is evident in the separation is a valuable and scientific way to avoid creating unusable data that needs to be subsequently invalidated following a defined analytical lab error/result SOP. But what do you do with that orphan data?

Categories: Data Integrity
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Data Integrity Matters | Limiting Access to Tools That Could Be Used to Manipulate Data (Part 1)

By April 2, 2018

Removing the ability for individual users to either delete data or to disable audit trails is expected to be both implemented and validated for data integrity. But when changes are required, what editing tools should be accessible to an analyst?

Categories: Data Integrity
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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