The FDA has provided guidelines for electronic submissions as set out in Title 21 CFR Part 11. The guidelines include a set of definitions and required controls but the FDA is not structured or funded to provide certification of applications or vendors. As such, certification on Title 21 CFR Part 11 currently doesn’t exist. Individual companies must bear the responsibility to evaluate whether systems have controls that meet the guidelines for a closed system. Recently, a large biotechnology client evaluated the Firmex Virtual Data Room solution and concluded that Firmex met the requirements for a closed system as defined in Title 21 CFR Part 11. Here is the definition: “Closed System” is an environment in which system access to the Technology is controlled by persons who are responsible for the content of electronic records that are on the system. For further information on Title 21 CFR Part 11, visit http://www.21cfrpart11.com/
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