How does labfolder comply with GLP guidelines?

The legal standard for electronic lab notebooks is stated by the OECD Series on Principles of Good Laboratory Practice (GLP) and Compliance Monitoring. As equally compliant documentation tools since 1997, digital archives and electronic signatures are specifically explicit in GLP Series No 1, No 10 and No 15.

This means a full audit trail (i.e. every modification made to the document are recorded with a timestamp) and a prohibition to delete any data are prerequisites for the compliance with GLP. labfolder ELN keeps every entry’s history including date, time and content of each modification in a chronological order. Users can view the history and retrieve the old data.

Although entries are shared among group members, only the author can modify an entries’ content. Thus the history also clearly tracks who made changes in a project.

Entries can only be hidden but not deleted. Prohibition of project/folder deletion is set by default. If a group admin changes the setting, warnings are always displayed before removal. Multiple instances of confirmation are required before anything is deleted.

The option to export your labfolder projects as PDFs is always provided in the warning lightbox. Any exported PDFs are provided with a page number, date and timestamp, and a signatory field. As an essential component of laboratory equipment, labfolder ELN easily complements your paper notebook.

For further information, please download our dedicated whitepaper:

labfolder and GLP Compliance

 

labfolder and good laboratory practice compliance

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