Seventy nine per cent of the pharmaceutical sector's IT directors and managers are finding compliance with FDA's 21 CFR Part 11 to be a challenge.
Seventy nine per cent of the pharmaceutical sector's IT directors and managers are finding compliance with FDA's 21 CFR Part 11 to be significantly or very significantly challenging; that is, according to a survey conducted by Hitachi Data Systems and NE Computing. The survey also highlighted the fact that the introduction of modern IT may be stifled as a result of the uncertainties about compliance requirements and regulation enforcement. Of those questioned, 68% blamed FDA for the confusion, particularly its inability to produce clear guidelines. Other problem areas mentioned as part of the challenge include the high volumes of data involved; cost-effective compliance; and finding IT suppliers with the required experience.
"One of the big concerns revealed by our findings was that while the regulations were enacted to make electronic information more acceptable and encourage the introduction of more efficient IT systems for collating, analysing and maintaining data, 77% of respondents said the difficulties associated with compliance have actually held back the introduction of paperless systems," commented Trevor Williams, software solutions manager, EMEA, at Hitachi Data Systems. "This is very significant as the use of modern IT is essential for helping the industry speed up the development and testing of new products."