Mark E. Newton | Authors
Articles
The Question of Chromatographic Integration in Data Integrity
The topic of chromatographic integration and data interpretation raises a lot of questions about data integrity. Is it acceptable to integrate data? What are the limits?
Data Integrity in the Chromatography Laboratory, Part VI: Open Culture, Training, and Monitoring Metrics
The final part of the series discusses the importance of an open culture, training, and monitoring metrics in the establishment and support of a regulated laboratory.
Data Integrity in the Chromatography Laboratory, Part V: Second-Person Review
The series continues with a crucial scientific and regulatory necessity in ensuring reliable information-the second-person review.
Data Integrity in the GXP Chromatography Laboratory, Part IV: Calculation of the Reportable Results
You need to ensure that your calculations of reportable results don’t get you into data integrity trouble. Here’s how.
Data Integrity in the GxP Chromatography Laboratory, Part III: Integration and Interpretation of Data
Integration is the heart of the chromatographic process and is subject to regulatory scrutiny. What should be done to control integration and interpretation of the chromatographic runs?
Data Integrity in the GxP Chromatography Laboratory, Part II: Setting up a Chromatograph and Acquiring Data
Part II of this series on practical perspectives on data integrity focuses on instrument setup, system suitability test samples, and data acquisition.