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European Biopharmaceutical Review

The End of the Line for Paper

 

The biopharmaceutical environment is highly regulated, and therefore necessitates effective document management processes. In addition to the strict regulatory environment, which encompasses pharmaceutical documentation, organisations operating in this sector must also find ways of processing an increasing volume of information. Additionally, sponsor organisations must comply with increasing regulatory demands, particularly with respect to electronic submissions for approval.

To manage data efficiently, many companies are implementing electronic document management systems (eDMS) to assist in the storage and organisation of electronic records. The document lifecycle is controlled so that periodic reviews, regulatory changes and design modifications to the installed manufacturing plant, lab equipment and clinical trials, as well as re-training and assessment of operators, can all be managed within one seamless system. These systems are used for managing both digital and printed documents (once scanned in), and are flexible enough to allow existing documentation to be incorporated into the system while enabling full compliance with current regulatory standards. This article will discuss the increasing need for effective document management strategies within the pharmaceutical industry, the regulatory issues affecting pharmaceutical document management and the growing use of eDMS, in particular for biotech companies wth limited resources, both to purchase software, validate it and maintain it.


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Keith Williams founded Good Products in 2006. Keith has many years of biopharmaceutical consultancy experience, particularly in computer systems validation, and computerised systems training in manufacturing, clinical and laboratory environments. He has a BSc in Genetics and Microbiology and an MSc in Biochemical Engineering.

Patrick Hughes joined Good Products in 2007 and is Senior VP, Strategic Business Development. Previously, Patrick worked for the clinical technology organisation, ClinPhone plc, in various senior management roles including sales and marketing, product management and strategic business development. These roles focused on the commercial management and strategic direction of IVR, ePRO, EDC, patient recruitment and CTMS technologies.

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