The Food and Drug Administration (FDA) is expected to issue a revised version of its regulation on electronic signatures and records by the end of the year, which will force drug and device companies to reconsider their current information management systems.
The regulator is preparing for its Third Annual FDA Information Management Summit, due to take place next month and designed to help life science companies address the anticipated challenges of the revised 21 CFR Part 11 regulation.
The FDA has acknowledged some of the challenges faced by the pharma industry as a result of its regulation, which has been blamed for restricting the use of some electronic systems, discouraging innovation in some cases, and resulting in significant costs.
According to industry analysts, the costs associated with Part 11 compliance vary from $5m (€4m) to $400m per organisation, depending on the size and state of compliance of the company - costs that are set to increase with new revised version.
Although the FDA's self-imposed deadline for issuing the revisions is approaching, the industry may have some extra time on its hands as other media reports have suggested that the deadline was unrealistic and that it was questionable to see the revised regulation in early 2007.
21 CFR Part 11, first implemented in 1997, is aimed at providing criteria under which the FDA will consider electronic records to be equivalent to paper records, and electronic signatures equivalent to traditional handwritten signatures.
It applies to any paper records required by agency regulations and supersedes any existing paper record requirements by providing that electronic records may be used in lieu of paper records.
However, since its introduction, the 21 CFR Part 11 regulation has been criticised and blamed for being tricky to understand and difficult to implement, because of very high costs involved.
Significant discussions have ensued between industry, contractors, and the agency at the time concerning the impact of the regulation on the industry and the FDA issued an updated version of Part 11 in August 2003 that narrowed and clarified its scope.