Medical Device Link.

Originally Published MDDI December 2001

NEWS & ANALYSIS

Figure 1. Economic impact of Part 11 compliance. (Click to enlarge.)

Companies and organizations required to comply with 21 CFR Part 11, FDA's rule governing electronic signatures and records, are finding the task "ambiguous," according to a recent poll conducted by NuGenesis Technologies Corp. (Westborough, MA). Thirty-eight percent of the respondents admitted they do not fully understand the implications of Part 11 as it affects their companies.

Responses also indicate that efforts to achieve compliance measures are lagging. While 75% of the respondents claimed they have begun putting Part 11 measures in place, only 11% said they were fully Part 11 compliant in at least some areas.

As the figures below illustrate, the majority of involved parties believe that achieving Part 11 compliance will have a substantial economic impact on their business (Figure 1). The respondents' most significant point of anxiety involving Part 11 stems from the potential impact of the regulation on their company's legacy systems. Twenty-four percent of the respondents cited legacy system changes as their greatest concern regarding the regulation, with data archival and retrieval listed next, at 19% (Figure 2).

Figure 2. Greatest concern regarding Part 11 compliance. (Click to enlarge.)

Perhaps the more interesting finding of the poll came when respondents were asked what the most significant factor would be in helping them achieve compliance. The highest percentage of respondents (22%) cited their vendor's technology improvements—not their own company's internal changes—as the most important tool for achieving compliance.

The poll received 325 responses from various fields, including scientists, managers, consultants, and regulatory compliance officers. The respondents represent pharmaceutical, biotechnology, and contract research organizations.

Copyright ©2001 Medical Device & Diagnostic Industry