“Manipulating Chromatography Data” (for Fun and Profit)
Mark Newton has been employed for 33+ years by Eli Lilly and Company in several cross-functional roles. Starting as a Microbiologist, he spent 14 years within the chemical, pharmacological, and microbiological areas of QC Laboratories as an analyst, method developer and supervisor. The balance of his career has been within IT and Quality, implementing GMP software, serving as computer system QA, then a Laboratory Data QA representative, developing standards for qualification of laboratory computerized systems and training lab personnel in data integrity auditing, gap identification and remediation techniques.
He is co-editor of the GAMP Good Practice Guide: A Risk-Based Approach to GxP Compliant Laboratory Computerized Systems (2nd ed), and currently co-leader of the GAMP Data Integrity Special Interest Group (SIG) and the ISPE Global Documents Committee. He has recent publications in Pharmaceutical Engineering, Scientific Computing and the ISPE Blog (ISPEAK).
Chromatography data is central to most laboratory operations. Unfortunately, even with a restrictive configuration and procedural controls, there are a number of ways for laboratory analysts and reviewers to manipulate chromatography systems to make tests or tested articles appear to be better than their true condition. It is imperative that companies establish analytics and review practices that are able to detect and prevent such improper manipulations.
Presentation will offer some examples of improper manipulation, discussing their motivations and detection. Some examples will be obvious and others, subtle. Examples will be based on Empower CDS, but will be applicable to majority of other systems as well.