Tools for Chromatographic Success: Three Ways to Support Data Quality in Routine Analysis

Tools for Chromatographic Success: Three Ways to Support Data Quality in Routine Analysis

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…

Change Up Your Routine (Analysis)

Change Up Your Routine (Analysis)

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 testing for decades. It has proven to be particularly important for quality control and manufacturing support laboratories in the pharmaceutical…

Data Integrity Matters: Unknown, Unintegrated or Undetected Chromatography Peaks

Data Integrity Matters: Unknown, Unintegrated or Undetected Chromatography Peaks

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)

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

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…