Publications

ISPE/GAMP Publications

GAMP Guide: Records and Data Integrity. ISPE Publications, 2017. 152pp. (co-author)

GAMP Good Practice Guide: A Risk-Based Approach to GxP-Compliant Laboratory Computerized Systems (2nd ed.). ISPE Publications, 2012. 156 pp. (co-author/co-editor)

Periodicals

Data Integrity in the GxP Chromatography Laboratory, Part I: Sampling and Sample Preparation. Newton, McDowall. LC/GC Magazine 36(1), Jan 2018, pp. 46-51.

Data Integrity in a Nutshell: Industry must take bold steps to assure the data used for drug quality decisions is trustworthy. Scientific Computing (Jan 2014).

Data Integrity in the GxP Chromatography, Part II: Setup and Data Acquisition. Newton, McDowall. LC/GC Magazine 36(4), Apr 2018, pp. 270-274

Harmonizing USP <1058> and GAMP for Analytical Instrument Qualification. Schuessler, Newton, Smith, Burgess, McDowall. Pharm. Engineering, Jan/Feb 2014 (co-author)

Data Integrity in the GxP Chromatography Laboratory, Part III: Integration and Interpretation of Data. Newton, McDowall. LC/GC Magazine 36(5), May 2018, pp.330-335

Data Integrity Metrics for Chromatography. Newton, McDowall. LC.GC Europe Magazine vol. 30(12), Dec 2017, pp. 679-685.

Data Integrity in the GxP Chromatography Laboratory, Part IV: Calculation of the Reportable Results. Newton, McDowall. LC/GC Magazine 36(7), Jul 2018, pg 458-462

Research ‘Misconduct’ Will Be Big. 9 Aug 2018.

Data Integrity in the GxP Chromatography Laboratory, Part V: Second Person Review. Newton, McDowall. LC/GC Magazine 36(8), Aug 2018, pp.527-529

Questions of Quality: Data Integrity Metrics for Chromatography. Newton, McDowall. LC/GC Europe 30(12), Dec 2017, pp. 679-685

Data Integrity in the GxP Chromatography Laboratory, Part VI: Data Integrity in the Chromatography Laboratory, Part VI: Open Culture, Training, and Monitoring Metrics. Newton, McDowall. LC/GC Magazine 36(9), Sep 2018, pp 686-692