FDA presents pharmaceutical poser

The enforcement of paperless submissions and electronic record keeping, as described by the US Food and Drug Administration, could present as big a problem to the drugs and food industries as did Y2K.

The enforcement of paperless submissions and electronic record keeping, as described by the US Food and Dug Administration, could present as big a problem to the drugs and food industries as did Y2K.

The US Food and Drug Administration (FDA) has announced federal regulations ensuring that companies comply with standards for electronic record keeping and the use of electronic signatures. Known as 21 CFR Part 11, the regulations have been in effect for three years but have not been enforced until now because of the investment being made to sort out the Y2K problem. The regulations will have a major effect on manufacturers not just in the USA but across the World. Intellution believes that compliance to the regulations will present a software problem, which will challenge Y2K in its magnitude.

‘Our customers tell us that the need to comply with 21 CFR Part 11 is having an even greater impact on them than Y2K preparedness,’ said Steve Rubin, Intellution’s CEO (pictured). ‘We’ve built our business on both anticipating and quickly responding to our customers’ most pressing needs, so it’s natural for us to take a leadership position on this issue. We are working closely with customers and experts to make sure that we can help users meet this formidable challenge.’

Intellution has undertaken a study to ensure that its software complies with the regulations and is co-authoring a paper aimed at helping users make sure they are compliant with the new regulations. A number of steps toward providing 21 CFR Part 11 functionality in software products have already been taken. In August, the company sponsored an industry symposium on the regulations attended by pharmaceutical company representatives, consultants specialising in 21 CFR Part 11, and others. And other symposia will be conducted in the near future for additional global customers.

The regulations went into effect in August 1997 and establish standard methods of electronic record keeping and submissions to the FDA. Among those records are biologics license, product license, and new drug applications. The regulations also provide the criteria for the use of so-called ‘hand written’ electronic signatures – the computer-generated equivalent of an individual’s unique signature. The 21 CFR Part 11 regulation also requires the validation of the automation systems used in data collection and record keeping ensuring accuracy, reliability and security.

The agency has recently become more diligent about enforcing the regulations by issuing inspection observation documents and, in some instances, warning letters. FDA has the power to shut down operations that are not in compliance. Naturally this can only happen in the USA but FDA also has powers to prevent the import of non-compliant products into the USA.

Complying with 21CFR Part 11 requirements is critical for all pharmaceutical manufacturers and the regulations are bound to affect other industries such as food and beverages in the future. FDA suggests that a paperless system will provide user benefits of better speed of information exchange, improved ability to integrate, trend and search data as well as a reduction in errors and costs related to data storage. Intellution’s strategic partner in the UK is Fortétion. The company will distribute Intellution solutions, products, services and support in the United Kingdom and Ireland. Intellution is a minority shareholder in the new venture, which is headed up by Andrew Ballard.

Fortétion will also provide training, application engineering, consulting services, OEM engineering, component development and technical development services. The company will not, however, provide system integration services.