Current FDA Thinking on 21 CFR Part 11: Effects Upon IT Vendor Strategies [DOWNLOAD: PDF]

Current FDA Thinking on 21 CFR Part 11: Effects Upon IT Vendor Strategies [DOWNLOAD: PDF]

Shop at Amazon.com

 

  • Author(s): IDC, Mark Hall
  • Format: Adobe Reader (PDF)
  • Printable: Yes. This title is printable
  • Mac OS Compatible: OS 9.x or later
  • Windows Compatible: Yes
  • Handheld Compatible: Yes. Adobe Reader is available for PalmOS, Pocket PC, and Symbian OS. 
  •  Publisher: IDC; ISBN: B00008YICW; (March 1, 2003)

Description:  This IDC study will examine the trends and events in the pharmaceutical and medical device industry as a result of 21 CFR Part 11 and of the FDA’s latest regulatory guidance issued on February 20, 2003. It will explain Part 11 at a high level and describe current FDA thinking related to Part 11. Additionally, it will highlight how IDC believes the new guidelines affect those in the IT vendor and consulting community that offer regulatory compliance solutions. The Essential Guidance section contains IDC’s position on new challenges faced by the vendor community and presents our thinking on how vendors should refocus short- to medium-term product development and strategic marketing in light of the new FDA guidance. Mark Hall, director of IDC’s Life Sciences and Healthcare research program, comments: “The FDA believes that the industry has misinterpreted 21 CFR Part 11 to be more broadly applied than the agency originally intended. Many in the consulting and vendor community shared in this misinterpretation and built regulatory compliance solutions based on industry prevailing assumptions and position documents. Perhaps more importantly, consulting and IT vendor strategies that, until this new guidance appeared, were crafted to target the monies that life sciences companies had put aside out of concern for regulatory compliance have lost much of their urgency. In light of this shift in regulatory emphasis, vendors face significant product and strategic marketing challenges.”