Reviewing Paper-based Records is Tedious and Slow.

Quality Unit and Production managers realize the importance of reviewing lab notebooks, logbooks, and batch records. Unfortunately, much of that review work is done manually. Lab notebooks, log books, data packets, and data entry forms all have to be checked and rechecked for accuracy and authenticity to verify that raw data are retained to support results.

• QC tests correspond with batch manufacturing dates?
• Equipment identification numbers and calibration dates documented?
• Expired reagents used by mistake?
• Material quantities reconciled?
• Calculations done correctly?
• Handwriting make records illegible?
• Is all this done in a timely fashion?

In paper-based data review processes, the most significant time sink is that reviewers need to look at everything. Given the volumes of data produced on a daily basis, it would be easy to overlook a mistake that might cause an investigation later on. Not only is the review process time consuming, but the resulting rework loops cost significant time and materials.

Reviewing Electronic Records is Simple and Fast!

Fortunately, SmartLab gmpELN offers a solution to the data review blues we like to call "review by exception". Any deviations that may occur during the execution of an automated procedure in the VelQuest system is tagged with a color-coded flag on the SmartLab data review dashboard.

Records cannot be rewritten or changed. But if data are retaken, the original value still resides as a permanent part of the record and is flagged on the dashboard. The system captures audit trails, electronic signatures, reasons for change, and even annotations so you don’t have to get an explanation from the analyst after the fact. Because validated calculations reside within the validated procedures, transcription and calculation errors are eliminated.

Want to see the original instrument report or an audit trail? Just click the color coded flag on the data review dashboard and it appears on-screen for review. And because the sample ID, user ID, method, preparation data, and results are all dynamically linked and accessible on the dashboard, you’ll never have to physically roam the labs or document storage areas looking for that particular data binder, log book or form in the event of an audit.

To learn more about the SmartLab data review dashboards and how much time it saves you, visit our Products page.