Columns | Column: Focus on Quality

It is just over two years since USP <1058> on Analytical Instrument Qualification (AIQ) became effective. To coincide with the American Association of Pharmaceutical Scientists (AAPS) Meeting in New Orleans this month where a roundtable discussion on the subject will be held, here are my views.

How good is documentation supplied by a vendor to support the qualification of an instrument or the validation of a laboratory computerized system?

Bob McDowall looks at the different life cycle models that apply in the laboratory to GAMP software categories 3, 4, and 5.

Getting the best business value from a spectrometer requires knowledge of the instrument and its operating abilities, any attachments, the sample including sampling procedure and presentation, and the software. All of these elements must be pulled together by a skilled and knowledgeable spectroscopist. Unfortunately, this is not always the case in many organizations.

The new FDA Commissioner wants a strong FDA and is backing her words with action by initiating a program that cuts the time that firms must respond to 483 observations from 30 to 15 business days. Not only is the time halved but the response must be complete. Therefore it is better and cheaper to be compliant than not.

The GAMP (Good Automated Manufacturing Practice) guide version 5 was released in March 2008 and one of the changes was that the classification of software was revised - again. This column will look at what the changes mean for the laboratory and whether all of these should be implemented.

In this column, Bob McDowall discusses the impact of USP general chapter 1058 on the spectroscopy laboratory.

The second part of this column series on traceability matrices looks at some of the practical ways of tracing requirements from the user requirements throughout the life cycle documents.

Tracing requirements from a user requirements specification throughout the life cycle is not only a very effective business tool to save time and effort in validation projects but also a regulatory expectation. This first installment of a two-part column series looks at the principles of a traceability matrix.

Columnist Bob McDowall discusses the role of a validation master plan (VMP) for summarizing a laboratory's approach to computer validation.

In this "Focus on Quality" column, we will look at the overall GMP changes and then ask the following question: Why has the laboratory not been included in the proposed changes?

Paper is easy to archive, but what about archiving electronic records? What do you do with all the electronic records that are generated? In this month's installment, columnist Bob McDowall explores the issue of electronic records management and looks at the recent guidance issued by the OECD for GLP laboratories.

Using information provided by guidance documents from outside the spectroscopy laboratory can be very useful when trying to meet the regulations that we must follow.

Columnist Bob McDowall discusses operating system security patches.

Columnist Bob McDowall discusses the use of audit trails in the software applications used to control spectrometers that acquire, interpret, and report results from analyses. An effective audit trail is imperative to ensure the integrity of the data and the conclusions reached by the spectroscopist.

Columnist Bob McDowall takes an NIR spectrometer through the process outlined in his November column, in which he suggested an integrated approach to equipment qualification and computerized system validation for spectroscopy systems.

Columnist Bob McDowall proposes an integrated approach to the combined issue of equipment qualification and computerized system validation for spectrometers that combines the qualification, day-to-day calibration, and maintenance of the instrument with the validation of the software for a system?s intended purpose.

A simplified risk analysis methodology is needed for the validation of commercial software used in the regulated laboratory. In this column, the author takes a look at two alternative approaches.

This month's "Focus on Quality" presents a critique of the GAMP Good Practice Guide. And while columnist Bob McDowall finds much to recommend in the guide, he finds much more cause for concern.

Accurate and precise time and date stamps are critical to ensuring integrity of the data and results generated by each computerized system used in any spectroscopy laboratory.

The author continues his discussion of the principles involved in the backup and recovery of electronic records. This installment looks at the written procedures associated with this process for a spectrometer operating in a regulated laboratory.

Part IX of the series discusses backup and recovery, which are essential to the process of ensuring data security and integrity.

Part VIII of the series covers change control and its importance in maintaining a system's validation status.

This column discusses training and system documentation, and how to write a validation summary report.

The author discusses how to identify some of the performance qualification tests to apply to spectrometry software, how to write the test procedures and instructions, and how to execute the actual testing.

This installment of the ongoing series discusses performance qualification of software in regard to system requirements.

An installment of the Focus on Quality column.

Part three in the author's ongoing series about validating spectrometry software.

Columnist R.D. McDowall discusses the process of validation of spectrometry software.