Quality & Control

Overview of Release Management


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Release management can be defined as a process of monitoring and controlling the flow of various changes into an IT infrastructure. Each of the upgrade or update of a configuration point is called a release. It is important to note that there are three major levels of releases that are worth mentioning and these levels […]

Supplier Vs Regulatory Audits


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Recently we have been asked to perform several gap analyses exercises for supply chain organisations that are hoping to win business with pharmaceutical clients.  There has been a mismatch in what WE, have been asked to do, so I thought that writing this short and to-the-point article would be useful. Regulatory Firstly, in this context […]

Case Study – Project Structures DO WORK!


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Background A small group of computer system validation specialists were working on a client project to help validate a legacy computer system in response to a regulatory citation.  On arrival to the site and during the elicitation of the user requirements (required as part of the validation package) it was identified that there was no […]

The Power of Word Processing and Typing Skills


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Everyday we all use computers to do our work, most of us, to some extent are required to use a word processing application to at least some extent. The de-facto word processor in most cases is Microsoft Word and to take a guess, most of us are using a minimum version of Word 2003 with […]

Documenting a Network Infrastructure


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Network Qualification – What You Need To Know Qualified Infrastructure is a must for hosting any validated cGxP system; Network Qualification is a fundamental component of any Infrastructure.  Networks are complicated and not many people really know about them, but how complex are they? To qualify a network, the first task is to perform an […]

Benefits of Proceduralised Systems


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Everything we do, at work or at play is a process driven task!  Fast.  Whether this is making a cup of tea (yes, there is a British Standard for this too!), mowing the lawn, feeding the dog or preparing a VAT return for HMRC.  In order to ensure that our processes are carried out efficiently, […]

An Easy Way to Validate an SQL Report


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When validating computer systems and applications an array of screenshots and other such supporting documentation is frequently used.  All too often, supporting information is simply stored in a database and is easily accessible, which means that the information can be extracted by use of an SQL query and presented in a user-friendly format with a […]

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