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Tracking and Audit Trailing

If an inspector wants to audit your facility tomorrow you will need to be able to prove that your staff have the ability and training to perform their job competently. This article highlights the regulatory pressure facing pharmaceutical companies and how management solutions can help.

Clearly, the financial rewards are great for those pharmaceutical companies that gain new insight into diseases and then develop wonder drugs that help arrest or treat them. But the regulatory requirements that govern the pharmaceutical industry are tight and growing tighter, and the need to manage compliance is crucial.

The impact of compliance is felt at every level - on drug substances and analytical research, on computer control systems and laboratory equipment, on Good Manufacturing Practice (GMP) operations and inspection techniques, and on documentation and people. And woe betide any organisation that fails to meet the standards. In the aftermath of a US$875 million settlement reached last Autumn between TAP Pharmaceutical Products and US federal prosecutors, pharmaceutical executives all over the world have been scrambling to understand how the bar has been raised for corporate compliance in their industry.


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By Mark Homer, Software Director at John Matchett Limited

Mark Homer is Software Director at John Matchett Limited (JML), having joined the company 14 years ago. He has been responsible for JML's software operation for the last 10 years. Mark has been involved in major projects for pharmaceutical organisations, helping them implement training automation and e-learning.

Other recent projects include the deployment of an e-learning infrastructure for a major car manufacturer and training and compliance systems for two major life organisations.

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Mark Homer
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