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Rochester, United Kingdom

McDowall B.,McDowall Consulting
LC GC Europe | Year: 2011

January 2011 saw the publication of the new revision of European Union (EU) GMP Annex 11 on Computerized Systems and Chapter 4 on Documentation. What will the impact be of these two revised regulations on computerized chromatography systems and chromatography data systems (CDSs) used in regulated GMP laboratories? © 2011 Advanstar Communications, Inc. Source


McDowall R.D.,McDowall Consulting
Bioanalysis | Year: 2014

This perspective article considers the strategy, design and implementation of an electronic bioanalytical laboratory working to GLP and/or GCP regulations. There are a range of available automated systems and laboratory informatics that could be implemented and integrated to make an electronic laboratory. However, which are the appropriate ones to select and what is realistic and cost-effective for an individual laboratory? The answer is to develop an overall automation strategy that is updated periodically after each system or application has been implemented to assess if the strategy is still valid or needs to be changed. As many laboratory informatics applications have functional overlap or convergence, for example, Laboratory Information Management System, Electronic Laboratory Notebook, and Instrument and Chromatography Data Systems, the decision of which application performs a specific task needs to be carefully considered in the overall strategy. Ensuring data integrity and regulatory compliance, especially in light of a number of recent falsification cases, is a mandatory consideration for the overall strategy for an electronic bioanalytical laboratory submitting data to regulatory authorities. © 2014 Future Science Ltd. Source


McDowall R.D.,McDowall Consulting
Scientific Computing | Year: 2013

The U.S. Food and Drug Administration (FDA's) emphasis on data integrity and some of the problems that their inspectors have found when visiting companies are discussed. The key issue when it comes to release testing is the requirement stated in 211.194(a) for complete data. Data integrity and the lack of complete data over the record retention period can be compromised in a number of ways, such as human errors when data is entered by mistake, selection of good or passing results to the exclusion of those that are poor or failing, and errors that occur when data is transmitted from one computer to another. The overall aim of the data integrity audit under objective 3 is to assure the FDA reviewers of the drug application that they can rely on the data contained in the submission as accurate and complete. Due to increased fraud detection by the agency and the issue of CPG 7346.832, all FDA inspectors have now undergone training in data integrity. Source


McDowall R.D.,McDowall Consulting | McDowall R.D.,R.D. McDowall Ltd
Spectroscopy (Santa Monica) | Year: 2011

The United States Pharmacopeia general chapter on analytical instrument qualification (USP 〈1058〉) and the ISPE's Good Automated Manufacturing Practice (GAMP) Good Practice Guide on laboratory computerized systems are the two main sources of guidance for qualifying analytical instruments and validating computerized systems used in the laboratory. This column explains the discrepancies between the two documents as well as changes now being made to both in an attempt to enable an integrated approach to qualification and validation of laboratory instruments and systems. Source


McDowall R.D.,McDowall Consulting
LC-GC Europe | Year: 2014

Chromatography data systems (CDSs) have had a starring role in many regulatory citations involving falsification and fraud in analytical laboratories regulated by Good Manufacturing Practices (GMP). In this instalment of “Questions of Quality” we will examine the citations and identify the technical and procedural controls required to ensure data integrity within these systems. Although focused primarily on the pharmaceutical industry, the principles described here are applicable to all laboratories working to established quality standards. © 2014 Advanstar Communications, Inc. All rights reserved. Source

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