FDA Electronic Signatures

Welcome to TechniCAL's library of thermal processing information. Here you will find an easy to access list of the FDA and USDA canning regulations, in addition to technical papers and articles written by TechniCAL personnel. You will need Adobe Acrobat reader to view these documents.

TechniCAL Topics

CALSoft Software- Does Part 11 Apply?
TechniCAL's CALSoft software is the industry standard for collecting & analyzing Heat Penetration and Temperature Distribution data. Does FDA's new Electronic Records regulation apply to CALSoft?

FMC's LOG-TEC System- Does Part 11 Apply?
FMC Food Tech manufacturers and sells the leading control system used in the food processing industry... the LOG-TEC Control System Does FDA's new Electronic Records regulation apply to LOG-TEC?
(LOG-TEC is a registered trademark of the FMC corporation)

FDA Documents

Guidance For Industry. (February 20, 2003)
Part 11, Electronic Records; Electronic Signatures Scope and Application This guidance document is intended to describe FDA's current thinking regarding the scope and application of Part 11 of Title 21 of the Code of Federal Regulations; Electronic Records; Electronic Signatures.

Part 11, Final Rule (March 20, 1997)
21 CFR Part 11, Electronic Records; Electronic Signatures
The final rule was issued by FDA on March 20, 1997.

Part 11, Proposed Rule (August 31, 1994)
21 CFR Part 11, Electronic Records; Electronic Signatures PROPOSED

Side By Side Comparison of Proposed and Final Rules