Friday, January 30, 2004

Oracle unveils new electronic signature functionality for FDA regulated manufacturers

At Oracle AppsWorld yesterday, I sat in on a presentation on Oracle's new solution for electronic records and electronic signatures (ERES), a requirement for companies regulated by the US Food and Drug Administration (FDA) under 21 CFR Part 11. I was quite impressed with Oracle's approach to satisfying these requirements.

Oracle has taken a clever approach to defining what is an "electronic record" for purposes of signing. One of the challenges of implementing electronic signatures in complex applications such as Oracle is that what the user thinks of as a "record" (e.g. a master batch record) may be logically stored in multiple tables in the relational database. So, when user signs an electronic record, what is he signing? And what does the signature apply to? Oracle solves this problem by presenting electronic records to the user in an electronic "paper format" that brings together all the information that forms the "record." When the user signs this "record," Oracle stores it with its signature information, in an "evidence store." The evidence store is maintained in XML format, separately from live files. Records in the evidence store represent what users have signed, and they can be printed or exported in PDF format, satisfying the electronic copies requirement of Part 11. Oracle's approach, to me, is attractive in that it makes electronic records and electronic signatures clearly equivalent to paper records and handwritten signatures, the key objective of Part 11.

Oracle's electronic signature capability was developed using its workflow engine, allowing all the functionality of Oracle's workflow to be applied, such as multiple approvers, designee assignment, and approval routings. Record update does not take place until all required signatures are executed.

Oracle has implemented its electronic signature framework in a modular fashion, allowing Oracle (or the client) to selectively enable signatures as desired throughout the system. So far, Oracle has enabled electronic signatures for 30 events that are important for compliance with good manufacturing practices. The focus in the current version (11i9) is primarily process manufacturing (i.e. pharma clients). Additional events for discrete manufacturing (i.e. medical device clients) will be available in the middle of this year (11i10).

Although Oracle's ERES solution has been in general release for about a year, in the presentation, Oracle indicated that its first installation is just going live this week. Oracle has put a lot of good thought into this functionality. This, along with its broad offerings for life science companies, such as its Clincial Suite (see my post earlier this week), indicate that Oracle is going to be a serious contender in this industry.

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