Electronic records final rule

FDA. Code of Federal Regulations, Title 21 Food and Drugs, Part 11 Electronic Records Electronic Signatures Final Rule, Fed Regr 62 (54), 13429-13466 (20 March 1997). 

Electronic Records, Electronic Signatures Final Rule, 21 CFR Part 11, Federal Register, Vol. 62, No. 54, US Food and Drug Administration, Rockville, MD (1997). Also available on the World Wide Web http //www.fda.gov/ora/compliance refypartll/default.htm. 

CFR Part 11 Electronic Records Electronic Signatures Final Rule Federal Register 1997, 62,... 

FDA, Electronic Records Electronic Signatures Final Rule, 62 Federal Register 13430 (March 20,1997). 

ERSR Agency Charter. Federal Register-Electronic Records Electronic Signatures, Final Rule, March 20,1997. 

FDA (1997), 21 CFR 11, Electronic Records, Electronic Signatures, Final Rule, Eederal Register 62, pp. 13430-13466. 

McDowall, R.D. The Impact of 21 CFR 11 (Electronic Records and Electronic Signatures Final Rule) on Bioanalysis, Chromatographia 55(Suppl S), S85-S90 (2002). 

This regulation including its preamble and the final rule itself detailed the minimal requirements. The interpretation of the rule is stronger than the printed word. The goal of FDA was to require electronic records and e-signatures to be reliable, trustworthy, and available to the Agency for inspection. 

As the EPA moves toward the eventual finalization of its own rule, currently scheduled for finalization in the spring of2003, the pressure will mount for EPA investigators and the regulated community to learn about the benefits of the electronic records and... 

Narrowly focused, the tenets of 21 CFR 11 are indisputable that firms must establish and maintain the integrity of their electronic information. What has been lost is the clear indication of which electronic information the requirements apply to. In my opinion, data generated outside a computerized system, that are manipulated by that system and are ultimately available in hard copy should not be subject to this ruling. Validation of the computerized system should be more than sufficient to establish that the final documentation accurately reflects the input information. In that instance, the computerized system is little more than a tool whose functionality can be readily established, yet firms are endeavoring to assure 21 CFR 11 compliance for numerous systems in which the computer is little more than an adjunct to the cGMP activity and corresponding hard copy. Batch record preparation, SOP and test method archives, and many process equipment control systems are examples of systems in which requirements for 21 CFR 11 compliance appear excessive. A system that processes or communicates data or records and subsequently retains and stores hard copies should not be subject to the 21 CFR 11 requirements. Far too many systems are being unnecessarily held to the very restrictive portions of 21 CFR 11. Electronic record retention as defined in 21 CFR 11 has its place, but not necessarily in every computerized system used within the industry. 

The following list summarizes regulatory issues that can impact databases. Many of these are specifically addressed to the FDA s Final Rule on Electronic Records Electronic Signatures (21 CFR 11). 

Final Rule on Electronic Records and Electronic Signatures... 

There is a caveat to the application of Part 11. As noted, it is a permissive rule. Industry has the option of compliance. However, if a company currently uses any electronic systems to create, sign, modify, store, access, or retrieve records, it is presumed by the law that they have elected to follow the regulations and comply with the standards. Consequently, the company is subject to FDA enforcement of the rule under the food and drug regulations. If a company elects not to comply with the regulation, it must revert to all paper systems. No electronic systems are grandfathered under the Final Rule. Continued reliance on current electronic systems for any one of the electronic records management activities requires compliance with the requirements of Part 11 for security and controls.f (Preamble Comment XVI.C.l, p. 13463.)... 

Much dialogue took place between the industry and the FDA during the development of the rule, and the final result is better and more practical as a result. However, there are significant difficulties with the rule as it stands, particularly with its application to noncompliant electronic records generated with systems that were in place when the rule became law, the so-called "legacy systems" problems. 

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