Compliance Features

Modified on Fri, 29 Apr 2022 at 12:17 PM


View history

A key feature of your ELN is the fact that all Entry creations and edits to an Entry are recorded, along with the time and date of the action. This is then collected as a full audit trail, which can be viewed alongside the Entry. By clicking on a specific edit, the Entry will be shown as it was when that edit was made and highlighted in the window on the right. Green highlights indicate that an element was added, red means that something was deleted and yellow shows edited elements. This is useful to identify if at some point a mistake was made or simply to keep track of what has been done and when.

For more information on (review/retrieval of) recorded Entry information, read the article on History, please!

CFR 21 Part 11 Digital Signatures

Digital Signatures

Documents can be signed digitally in Labfolder. Digital signatures are compliant to FDA CFR 21 Part 11. When signing a Labfolder document, all content, including uploaded files, is saved. The four-eye principle can be applied as well, allowing a member of a Labfolder group to countersign the document.

Sign&Witness App

Labfolder’s ELN is equipped with a built-in free Sign&Witness App which allows the Entry author to mark an Entry as completed by providing their signature and by selecting one more person to witness. After signing an Entry, it cannot be edited anymore.

Signature Workflows App

The Signature Workflows App, which is a paid add-on to the Advanced Version, is designed to streamline the process of signing and verifying Entries in collaborative Projects, allowing reviewers to make a decision whether an Entry is ‘approved’ or ‘rejected’ and it also allows for re-editing of Entries.

Data Safeguarding

Safeguarding data in Labfolder

In Labfolder, invalid data cannot be deleted in accordance with laboratory documentation guidelines like GLP or ISO standards. Also, read the article on how to prevent data form being deleted for more information, please

Removing data from an Entry

Within an Entry, data blocks can be removed by clicking on the icon (top-right corner of the data block) and then choosing the Remove option. The data block will be removed, but is still accessible (and downloadable if it's a file) from within the full audit trail. Also, read the article on History for more information, please.

Removing Entries

Entries can be "removed" by clicking on the three-dots icon and then choosing the Hide Entry option. All "removed" Entries are hidden from view only and not deleted, however. A pop-up will inform the user of this fact.

Removing Projects

When choosing the Remove option in the Project settings, the user will be prompted whether the Project shall be removed or completely deleted. The delete option is only available if the admin settings of the group allow users to remove any content. Also, read the article on how to delete a Project or Folder for more information, please.

Controlling Project deletion in groups

In groups, the administrator can prevent users from deleting Projects (and thus any data at all) by choosing the corresponding option in the group settings. Also, read the article on Group settings for more information, please.

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