Recent posts

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?

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Enhancing Analytical Productivity by Breaking Down Silos (Part 2)

By October 30, 2018

For biopharmaceutical organizations working with contract labs, it’s important to consider how data and methods will be transferred and how generated data will be managed so that it meets data integrity and compliance requirements.

Categories: Pharmaceutical
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Get Empowered: Data Security | Tip #91, Restricting Access to Empower

By October 17, 2018
Empower tip-of-the-week

In this week’s tip, I thought it would be timely to answer a question I recently received that pertains to data security for chromatography systems: Restricting access to Empower Software and Empower projects.

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Enhancing Analytical Productivity by Breaking Down Silos (Part 1)

By July 20, 2018

Analytical methods transfer. Data integrity. A changing and more stringent regulatory landscape. All this, and more, impacts productivity in upstream and downstream biopharmaceutical processes. How is Waters looking to help address development challenges for biologics and biosimilars?

Categories: Pharmaceutical
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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?

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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?

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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?

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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 >

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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

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?

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