Pharma IT heads 'struggling' with US FDA data regulations, survey reveals

Complying with US FDA regulations on the submission of electronic records and signatures is proving a major challenge for IT departments in pharmaceutical companies in the UK, 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 consisted of telephone interviews with almost 50 IT directors and managers in UK pharma companies during August and September. Of these, 79% admitted that complying with the requirements of 21 CFR Part 11 on electronic records is a significant or very significant challenge.

'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,' said 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.

Lack of clear guidelines from the FDA about what is required for compliance was criticised by 68% of those surveyed. Other problem areas mentioned were the high volumes of data involved, achieving compliance cost-effectively, and finding IT suppliers with the required experience.

'There has 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 have assigned specific people to progress their compliance programmes.'

More than half the IT heads questioned (52%) believed that pharmaceutical companies are devoting adequate resources to meeting the regulations, but 57% felt IT suppliers could do more to help with compliance.