Transforming Quality Assurance in the Laboratory
At AIT Bioscience, we have taken an innovative approach to utilizing the electronic laboratory notebook (ELN). Since 2011, an Oracle-based solution, IDBS E-workbook ELN has been the backbone of our operations. Over the years, we have customized this application to become what it is today, a powerful tool for high quality, audit-ready bioanalytical data. We have looked past the “electronic sticker book” functions of the ELN and comprehensively integrated the entire lab into the solution by creating workflows, which support processes outlined in our standard operating procedures (SOPs). The alignment of our processes with the ELN has proven to be worth the effort as it continues to improve our lab’s transparency and traceability.
So what does our ELN mean for you as a sponsor?
In the table above, we capture key benefits our ELN provides to our sponsors and we put together a more comprehensive top 10 list of benefits that our ELN provides:
1. Real-time quality control (QC) logic is built into our templates, which helps prevent errors as they are occurring. This QC aids in meeting fast timelines because there are fewer mistakes to correct that may affect study data. This QC also removes steps for the scientists to do, which allows them to focus on the scientific aspect of their experiments.
2. Our templates are validated, which creates consistent processes from study to study.
3. Quality assurance (QA) audit processes are aided by all electronic records being only a click away. There are no paper notebooks to track down in the lab, and no QC process to go through.
4. Our ELN has the potential to allow for remote QA audits.
5. ELN has a fully compliant audit-trail, which reduces sponsor and data integrity risks.
6. Our ELN encompasses Metrology. All instrumentation is prevented from use if it is out of calibration or out of service due to a maintenance event. The ELN prompts AIT Bioscience employees on upcoming maintenance activities, which prevents delays.
7. The electronic training component prevents staff from performing work if not trained adequately. Additionally, the training feature has the ability to notify staff of necessary SOPs to review prior to performing a task. These steps help assure the quality of test results and reliability of the source.
8. CAPA, deviations, investigations, and QA audits are all performed within the ELN.
9. The ELN is used by AIT Bioscience personnel for method development/validation and sample analysis. All data related to sponsor projects are held in a secure manner within the system, which ensures that the history of the project remains with the company even if specific employees are out of the office or are no longer available.
10. The ELN aids scientific review of data including statistics and assists in generation of report tables. These additional steps deliver better results in a faster timeframe.
Learn more about our ELN and its capabilities by reading our recent blog post, ELN as More than a Lab Notebook, which describes the capabilities of the ELN. Another blog post features an event where our employees served as experts on the ELN topic for IDBS. Please be sure to also check out our award-winning ELN poster or contact us for more information.