21CFR11

EZQuant-ELN is designed to perform as a hybrid system. This means that you collect your data in an electronic format, with all the benefits of an electronic system, but the legally biding document is a hand-signed printout of the electronic document.

According to the FDA, "when persons use computers to generate paper printouts of electronic records, and those paper records meet all the requirements of the applicable predicate rules and persons rely on the paper records to perform their regulated activities, FDA would generally not consider persons to be "using electronic records in lieu of paper records" under §§ 11.2(a) and 11.2(b). In these instances, the use of computer systems in the generation of paper records would not trigger part 11 (Guidance for Industry. Part 11, Electronic Records; Electronic Signatures - Scope and Application, August 2003).

Compliance with 21CFR part 11 demands a massive investment from the organization in purchasing costs, system implementation and revision of working procedures. If you wish to enjoy the clear benefits of the ELN, but avoid the costs and complex adjustments associated with the transfer to a fully electronic environment, using a hybrid system ELN is the smart solution.

EZQuant-ELN is fully compliant with the FDA's regulation regarding hybrid systems, including generation of non-editable PDF versions of your electronic notebook, automatically generated date and time stamps and linkage between the paper printout and the electronic file.