Drowning in a Sea of Paper
Tedium
Supervisors, managers, and others who review data are all too familiar with the important but tedious paperwork involved in a typical lab operation. A myriad of 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.
 Scrutinizing every analyst notebook and lab log book is a painstaking process, and a huge time sink. Do analysis sequences documented in the notebooks correspond with batch manufacturing dates? Have analysts correctly documented weights, dilutions, instrument calibration dates, and other values correctly? Were expired reagents used by mistake? Are all the calculations done right? There’s also a handwriting style for each analyst in the lab – can you read them all? Is all this done in a timely fashion?
Simplify
Fortunately, the SmartLab GMP Electronic Notebook System is the answer to the problems inherent in your paper-based documentation processes. Anything that might cause an investigation can be addressed in real time using SmartLab. As deviations occur in the lab, the system will alert analysts and can provide them with user actions that you define, all in real-time. These deviations will also appear in a data review dashboard as color coded flags, enabling you to review by exception.
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.
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