What Are Orphan Data?

Abstract

The term orphan data is used frequently in the context of data integrity. What does it mean for chromatography data systems? How can we prevent or detect orphan data?

What Goes Around Comes Around?

“…The This culminated in a column instalment on the role of a CDS in falsification and fraud, with 10 suggestions made to avoid data integrity problems (18). Peak integration is a major way of ensuring compliance with specifications, but is also a subtle way to falsify results; tips to manage the process featured in two columns in 2015 and 2019 (19,20). Historically, 25% of data integrity warning letters were integration related (21)-so control peak integration.…”

“…Regulatory documents from the World Health Organization (WHO), Indian Pharmacopoeia, and the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) have been on the receiving end of extremely critical comments by both myself and in collaboration with Chris Burgess. I described the WHO guidance for good chromatography practices (44) as having sections organized at random with no logical order, and document numbering not following a numerical sequence (45,46). It should be fast-tracked to the round filing cabinet under your desk or the recycle bin.…”

Challenges in Obtaining Relevant Information from One- and Two-Dimensional LC Experiments

“…Finally, the added "green" benefit of reduced sol- vent use that is achieved through the use of capillary-scale columns ( 122) is especially pertinent when there is a need to eliminate chemical waste generation in non-laboratory settings. Both column and instrument design will also be impacted by manufacturing advances enabled by three-dimensional (3D) printing (123)(124)(125). Individual instrument components, including valves (126,127), fluidic connections and column platforms (128)(129)(130)(131)(132)(133), and detectors (134-136) have all been fabricated using additive manufacturing techniques (Figure 8).…”