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,… Read more >
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 >
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 >
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 >
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 >
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 >
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 >
How do data integration and reintegration affect data integrity?
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?
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?