Information from guidance documents used in clinical investigations can be very useful to help meet FDA regulations regarding computer security in analytical laboratories.

Users need to understand not only the operation of the computer system as required by their access privileges, but also the ethics and integrity required operating under any of the GMP or GLP quality systems.

The best parts of the GAMP laboratory system GPG are the life cycle models for both development and implementation of computerized laboratory systems.

Part 2 of the column explores using the right balance for the right job in the right way.

The implementation and validation of a new site-wide chromatography data system for a major active pharmaceutical ingredient custom manufacturer provided the opportunity to map and optimize the GMP and ISO business processes to use electronic signatures effectively. This article describes the process optimization and how it integrates with the validation activities of the system. This overall approach provides substantial business benefits from the use of electronic signatures as evidenced by the savings resulting from process improvement and by the fact that the non-GMP laboratories implemented a similar process to analyse and approve results electronically.

Bob McDowall stresses the importance of using accurate and precise time and date stamps to ensure the integrity of the data and results generated by computerized systems in any chromatography laboratory.

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.

In this column, the benefits of implementing a compliant CDS for both electronic records and signatures are highlighted.

The importance of data back-up and recovery is stressed and suggestions given...