Recent posts

Traceability in OneLab: OneLab configuration by the Lab Administrator

By August 14, 2020

Bringing increased confidence to sample preparation workflows using automation, smart laboratory tools and electronic documentation for recording analyst activities Consistency, accuracy, compliance and data integrity can each be improved with automation of laboratory processes. We… Read more >

Categories: Automation, Data Integrity
Tags: , , , ,

Change Up Your Routine (Analysis)

By June 23, 2020

Enhancing performance, mitigating risk, and improving efficiency Today, Waters introduced the Arc HPLC, a modern liquid chromatography system that replicates established test methods while delivering improved performance. HPLC has been a cornerstone of routine analytical… Read more >

Categories: Data Integrity, Pharmaceutical, Technologies
Tags: , , , ,

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
Tags: , ,

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
Tags: ,

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
Tags: , , ,

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
Tags: , , , , , ,

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
Tags: , , , ,

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
Tags:

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
Tags: , ,