biopharma compliance

Embracing Analytical Techniques Into Regulated Laboratories
March 2, 2021|
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To ensure compliance success in a changing regulatory landscape, laboratories must continually adapt. Learn how the compliant-ready Waters BioAccord LC-MS platform helps biopharma address the additional compliance challenges posed by the field’s complex analytical instruments.

Tools for Chromatographic Success: Three Ways to Support Data Quality in Routine Analysis
December 3, 2020|

Avoiding the pitfalls of data quality and integrity in the Pharma QC laboratory while running routine analyses is an ongoing challenge. Regulatory violations are frequently a result of a lack of complete data, suspect data, and improper audit trails. A recent report from Deloitte stated that data integrity violations account for over 70% of the…

in modern laboratory senior female scientist has discussion with another male scientist

Traceability in OneLab: OneLab configuration by the Lab Administrator
August 14, 2020|

Learn how to bring increased confidence to your sample preparation workflows using automation, smart lab tools and electronic documentation from Waters. This blog post was revised in September 2023 to include the most up-to-date information.

female chemist working in laboratory

Traceability in OneLab: Protocols Designed by the Expert Analyst
August 11, 2020|

OneLab, cloud-native laboratory software, allows members to securely design and implement sample preparation protocols for lab analysts. Learn more by reading this post, which was revised in September 2023 to include the most up-to-date information.

male scientist engaged in research in laboratory

Traceability in OneLab: Tracking the Analyst’s Completion of an Experiment
August 7, 2020|

Bring increased confidence in sample preparation workflows with OneLab, which enables you to track a lab analyst’s completion of an experiment. Read this blog post, revised in September 2023 to include the most up-to-date information, to learn more!

The Impact of Complex Global Supply on the Nitrosamine Crisis
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 their own quality processes for risks that could result in a similar contamination issue. Analytical data should assure confidence in…

Data Integrity Matters: Unknown, Unintegrated or Undetected Chromatography Peaks
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 are legitimate, and which are an indication of poor quality? Which are harmless and which are dangerous? Which are expected…

Data Integrity Matters: Limiting Access to Tools That Could Be Used to Manipulate Data (Part 4)
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 hands, with the wrong intent and without a robust training and review process, may be used by unscrupulous staff to…

Data Integrity Matters | Limiting Access to Tools That Could Be used to Manipulate Data (Part 3)
January 14, 2019|

How do data integration and reintegration affect data integrity?

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

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

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