ELN digital signatures and audit

Modules

digital signatures, audit and backup

Digital documents are easy to edit without a trace. This page describes how this ELN allows to prove that records are authentic and were indeed made on the claimed date.

Can one trust electronic records as much as paper?

Absolutely if proper measures are taken
this ELN does take these measures by backing up pages or entire ELN and digitally signing the backup copies

SHA512 algorithm is used for generating the digital signatures. After the backup is digitally signed, it is impossible to modify anything in its files (not even add one comma) without completely breaking the signature. This makes electronic records no less trustworthy than traditional paper records. SHA512 has no publicly known weaknesses and can't be "broken in" under any scenarios.

This procedure is carried out automatically and does not require user actions (except to initially configure the Auto Audit module). SHA512 keys can be automatically Emailed to any number of recipients at time of signing the project.

Example of SHA512 electronic signature for a project with 20 pages:

rTy6iJJYogOufVaBJ7028sJbw2jPATiqnyuypbCKmglmCj+PWfETitoKoIz7Fm6KR8Yzpy38uWM52Kl2hfMhDA==

After a single space character was erased from one of the pages:

25XEbx2tsPnoHov09JGT5Lfz8BFYTqICMBM1UC1frbf31EqyNyqvzAz+Ul2QRqWYAVz9A1No7NWCFIPx3g6KdA==

The user-edited project key no longer matches the original date-time stamped key.

Date-Time
User Credentials
ELN content

Send the key to any number
of trusted parties for storage

Your own email at a legally
trackable email server
or even @gmail.com
can be such a witness

Signing the data (manually or fully automatically)

Verifying the data using digital signatures

Date-Time
User Credentials
ELN content

Digital signature module VIDEO

Automatic Audit and Backup module

The program can be set to Email-report to self, project supervisor and/or any number of trusted parties each time a project snapshot and a digital signature are created on a researcher's computer. The creation of digital signatures can be set to a fully automatic schedule.

21 CFR part 11 compliance of the electronic record keeping

21 CFR part 11 sets a specific set of requirements to ensure legal integrity of the electronic records. BiochemLabSolutions digital signature module can be set up to automatically sign the projects and includes the following:

Manifestations to contain information associated with the signing of electronic records. This information must include the printed name of the signer, the date and time when the signature was executed, and the meaning (such as review, approval, responsibility, and authorship) associated with the signature. In addition, this information is subject to the same controls as for electronic records and must be included in any human readable forms of the electronic record (such as electronic display or printout).

Under Sec. 11.70, electronic signatures and handwritten signatures executed to electronic records must be linked to their respective records so that signatures cannot be excised, copied, or otherwise transferred to falsify an electronic record by ordinary means. Under the general requirements for electronic signatures, at Sec. 11.100, each electronic signature must be unique to one individual and must not be reused by, or reassigned to, anyone else.

Note, it is responsibility of the end users, not of BiochemLabSolutions.com, to use the applications in a compliant configuration. BiochemLabSolutions.com only provides the means to do trusted record keeping but does not control the use of the program.

Note that when configured properly, the approach used by the BiochemLabSolutions effectively eliminates the factor of Personnel Integrity. Even if the records are stored in a freely editable form on a researcher's computer, the distributed key will only match 100% authentic records. The scope of automatic key distribution can include a virtually unlimited number of parties (witnesses) who can challenge and verify or refute authenticity of the records in question using their own electronic key they receive by e-mail.