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European Pharmaceutical Contractor
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The last 15 years has seen a gradual yet inexorable growth in the adoption of electronic data capture (EDC) by both pharmaceutical and medical device industries. Estimates vary on the uptake rates with some references suggesting a figure between four and 15 per cent on a global scale (1). Undoubtedly the increase in the enterprise-wide adoption of systems has cemented the commitment of the industry to such technology. To date, the focus of attention has very much been on front-end trial set-up activities such as edit check and screen design rather than planning for end-of-life archiving.
However as the regulatory framework is becoming established, company polices and procedures towards archiving need to be developed. It is clear that many companies are proving slow to prepare for the regulatory challenge, with an independent survey indicating that only 50 per cent of responders were aware of specific US rules on electronic records (2). This article will examine several of the key factors concerning the archiving of EDC data and it seems appropriate to commence by revisiting the use of paper records.
The Established Model
The archiving of paper records is a well-defined and established model. Any move to EDC needs to successfully challenge this approach. Paper itself is a robust medium if treated correctly and testament to this fact is the collection of 12th Century documents held by the UK Public Records Office, amongst others. However the maintenance of paper records is subject to various risk factors such as environmental conditions (that is temperature and humidity), fire, flood and pest damage.
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