Complying with US Food & Drug Administration (FDA) regulations on the submission of electronic records and signatures, including data required for approval of new drugs, is proving a major challenge for UK IT departments in pharmaceutical and life science companies, according to new research conducted by Hitachi Data Systems and NE Computing. Furthermore, uncertainties about what is required for compliance and how regulations will be enforced may be hindering the introduction of modern IT technology.
The survey shows that 79 per cent of IT directors and managers within the pharmaceutical sector admit that complying with the FDA's Code of Federal Regulations Part 11 (21 CFR Part 11) on electronic records is a significant or very significant challenge.
21 CFR Part 11 is designed to let the FDA accept electronic records and signatures in place of paper records and handwritten signatures, with the aim of making electronic records and signatures as verifiable and traceable as their paper counterparts. The law, which includes the maintenance of data associated with clinical drug trials, outlines controls for ensuring that electronic records and signatures are trustworthy, reliable, and compatible with FDA procedures.
"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 per cent of respondents said the difficulties associated with compliance have actually held back the introduction of paperless systems," comments 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."
The FDA itself came under fire in the research with 68 per cent of those questioned admitting that one of the key problems they are facing is the lack of clear guidelines from the FDA about what is required for compliance. Other problem areas mentioned as part of the challenge include the high volumes of data involved, achieving compliance cost effectively, and finding IT suppliers who have the required experience.
In the US, complying with 21 CFR Part 11 is expected to cost the industry $2 billion by 2006 according to The Pharmaceutical Research and Manufacturers of America (PhRMA). But many pharmaceutical companies who have operations in the UK will also be trading or have interests in the US and so will be expected to comply.
"There have been a variety of messages about exactly what is required for compliance and how the FDA will enforce the regulations which, as the survey indicates, may have led to a lack of clarity within the industry," said James Gill, Business Development Manager at NE Computing. "But most of the organisations we talked to are taking the issue very seriously and have assigned specific people to progress their compliance programmes."
The majority (52 per cent) of the IT heads questioned believe that pharmaceutical companies are devoting adequate resources to meeting the regulations, but 57 per cent felt IT suppliers could do more to help with compliance.