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Meeting Regulatory Requirements for Electronic Signatures. Philadelphia , Pa January 26, 1999. Presentation by Daniel Worden at the Validation Institute LIMS Electronic Signature/Validation Conference. 21 CFR Part 11 Electronic Records; Electronic Signature. Milestones
Philadelphia , Pa
January 26, 1999
Presentation by Daniel Worden at the Validation Institute LIMS Electronic Signature/Validation Conference
11/91 Project Launched
7/92 Advanced Notice
8/94 Proposed Rule
3/97 Final Rule
8/97 In Effect
Authentic & Legal
21 CFR Part 11 Electronic Records: Electronic Signature
Part 11 Internet Web Site:
7520 Standish Place
Rockville, MD 20855
Paul J. Motise
Consumer Safety Officer
Division of Manufacturing and Product Quality, HFD-320
Center for Drug Evaluation and Research
Phone: 301-594-1089 Fax: 301-594-2202
Pursuant to section 11.100 of Title 21 of the code of Federal Regulations, this
is to certify that __________________ intends that all electronic signatures
Name of organization
executed by our employees, agents, or representatives, located anywhere in the
world, are the legally binding equivalent of traditional handwritten signatures.
“The agency believes that…it is vital to have stringent controls in place to prevent impersonation. Such controls include: (1) requiring an individual to remain in close proximity to the workstation throughout the signing session; (2) use of automatic inactivity disconnect measures that would “de-log” the first individual if no entries or actions were taken within a fixed short timeframe; and (3) requiring that the single component needed for subsequent signings be known to, and usable only by, the authorized individual
21 CFR 211.188 (b) (11) requires documentation of each significant step in the manufacture, processing, packing or holding of a batch including identification of persons performing, supervising or checking each significant step.
When humans are replaced by computer it is necessary to:
1. Prepare documentation to demonstrate adequate checks and performance of the system
2. Validation of the performance of the computer program controlling execution of the execution of the steps
3. Recording specific checks in batch production and control records of the initial step, any branching step and the final step.
4. Demonstrating that the computer system examines the same conditions that a human being would look for, and that the degree of accuracy in the examination is at least equivalent.
“As Is” processes
Electronic Record Retention