CFR part 11

Federal Register document 21 CFR part 11, entitled "Electronic records; electronic signatures; final rule.", is an American FDA guideline intended to permit the widest possible use of electronic technology, compatible with the FDA’s responsibility to promote and protect human health.

The document describes the conditions under which electronic signatures may be considered equivalent to paper records and handwritten signatures executed on paper. It also specifies the various procedures which must be in place in order for this equivalence to be recognized by the regulatory authorities.

Click here for CFR part 11 original document


Innovative solution by IPST/Solabs

Insofar as electrophysiology generates a wealth of electronic data, using customized and historically heavily modified commercial solutions, the implementation of a system which would allow compliance to document 21 CFR part 11 has proved to be quite a challenge for those companies performing applied electrophysiology.

In collaboration with Solabs Technologies Inc., IPS Therapeutique has developed a unique and innovative documentation database, which was specifically designed to handle the electronic files being generated as a result of electrophysiological experimentation, as well as those files resulting from analysis, reporting, archival and finally, quality assurance audits.

The solution developed was fully validated at IPST, and is commercially available under the name of "Solabs GxP solutions". Evidently, changes in procedures at IPST, as well as improvements made to the database and documentation software, are rapidly implemented and validated within our facility, through an ongoing collaboration with Solabs Technologies Inc.

Click here to visit Solabs website


Audit trace on all records and documentation

IPST's GLP compliance software, as far as 21 CFR part 11 is concerned, works by continuously monitoring all those workstations present within the facility. Whenever a file of a specific format appears on the hard disk of one such workstation, that file is immediately transferred onto a remote, fully protected server within IPST. The validated transfer technology allows the instantaneous and integral transfer of the original file onto the hard discs of the server, and associates it with a time and date stamp, as well as the electronic signature of the person responsible for creating or saving the file that has been transferred.

From the moment of its appearance within the protected database, the file transferred is subjected to a continuous audit trace, is protected by restricted access based on specific roles as well as hierarchy within IPST. In addition, said file can never be overwritten, but can only be modified in incremental versions.

Finally, each file is submitted to QA-defined approval cycles, which require the sequential electronic approval of those IPST personnel specified in proper SOPs.

Another module within the database handles standard operating procedures, personal training, general procedure renewal, as well as other facility-specific documentation. As for the actual electronic files being generated during studies, all those documents specified above are subjected to a complete and continuous audit trace and can be audited electronically by IPST quality assurance personnel at any time, and from any workstation