GXP Journal Articles
Vol. 19, Issue 2, Jul 2015

Richard C. Wedlich
,
Agata E. Libera
,
Joseph M. Fransen
,
C. Tellarini
,
T. Heath
,
N. Knight
This discussion provides an overview of a GLP program at a contract laboratory. The objective of the GLP program is generation of analytical data in support of a GLP study. Understanding what is required to complete a single study leads to understanding what quality systems must be in place in order to complete multiple and simultaneous studies.
Valarie King-Bailey, M.B.A.
Computer systems innovation is an ongoing fact of life. Businesses are now more productive than ever but have higher risk cybersecurity issues. Further, computer systems validation activities are often still conducted on paper and include inefficient wasteful practices. This paper discusses cybersecurity and validation, green “paperless”...
Jeanne Moldenhauer
In recent years there has been a significant increase in the number and types of data integrity issues that have been cited in regulatory inspections by both USA and European (especially MHRA) investigators. This increase has led to the FDA establishing the types of issues that should be considered red flags triggering a more intensive...
Orlando Lopez
This paper describes the concept of trustworthy computer systems in a GMP regulated activity and the regulatory requirements and key guidelines associated with trustworthy computer systems within the scope of the referenced competent authority.
Jerry Lanese and Timothy J. Fields, editors
A Column for Discussion of Issues Identified by Readers of the Journal of GXP Compliance. This column is one of a continuing series in which representatives of the industry and the regulatory agency have an opportunity to ask questions about, and express opinions on, current GXP issues. The Editors welcome your questions and your opinions on...
Paul L. Pluta
Welcome to Quality Management Forum. This feature will provide a forum for quality managers to share information about how they manage the various quality functions in their facilities.
Paul L. Pluta, Ph.D.
“Compliance Case Studies” provides a forum for compliance practitioners to share information about actual compliance experiences.