Bob McDowall is director at R. D. McDowall Ltd, Bromley, Kent, UK. A company involved in process redesign, the specification, implementation and validation of computerized systems, laboratory digitalization, data integrity assessment and remediation, training in these areas and auditing regulated organizations in the pharmaceutical and allied industries. He is also a member of the LCGC International Editorial Advisory Board (EAB).
LCGC Europe
In the welcome return of this column, Bob McDowall revisits the evolving topic of 21 CFR 11 compliance, as it applies to chromatographers. He examines the FDA's activities in 2003 and outlines the current status of its regulations over, and guidance for, electronic records issues.
LCGC North America
McDowall discusses how the needs of the regulated laboratory are changing the way chromatography data systems are designed and used.
LCGC North America
The author discusses the roles of MS and chromatography data systems within drug discovery analytical laboratories.
The first two parts of this series covered the fundamentals of a system and the specification, evaluation, and selection of a chromatography data system. Part III discusses the validation work in parallel with progress through the life cycle of the project.
Column editor McDowall discusses electronic records and signatures and the effects of legislation regarding their use within the pharmaceutical industry.
In the second installment of this series, the author looks at the first phase of the life cycle of a new chromatography system, bringing together a number of elements of the workflow and the functions as they are used in the laboratory.
Part I of this series of articles provides an overview of a chromatography data system, including the life cycle, key functions, and problems.
