Our Blog 
Keep up with the latest

How an ELN Mitigates the Risks Associated with Regulatory Compliance

Posted by Michael Price on Aug 17, 2012 2:00:00 PM

Paper notebooks are subject to increased scrutiny by an audit commission, since they lack traceability, generally do not follow common entry methodologies, are often difficult to read because of legibility issues and lack any mechanism for validation.  Furthermore, because they are restricted to paper, the continuation of experiments across multiple pages or even notebooks, can lead to confusion regarding experimental comprehensiveness.  Being paper, they are also subject to increased risk simply because of the environment common to laboratories as well as accidental loss or destruction.

Risk blog3a

Regulatory compliance risk can be lowered because:

  •  Security enforcement allows access to only authorized users with integration to corporate directories.

  • Comprehensive audit trails provide a traceability matrix to what has changed and who made the change.

  • Versioning assures a historical record of experimental data.

  • Quality of data is improved through mandatory fields, the use of forms, templates, controlled vocabularies, and checks.

  • Workflows improve the process through enforcement of stepwise progression.

  • Electronic signatures and witnessing assure proper data authentication in a timely manner.

  • Reporting features can produce integrity reports for auditors on-the-fly.describe the image

Download Whitepaper:  The Value of  Electronic Laboratory Notebook Technology

Latest Posts