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AIT Bioscience Presents Poster at the Society of Quality Assurance Annual Meeting

The Case of the Failing Pipette Last week, Anaheim, California hosted the Society of Quality Assurance (SQA) 34th Annual Meeting. The SQA Annual Meeting is committed to advancing the standards of quality assurance. The theme for this year’s SQA annual meeting was The Wonderful World of Quality. During this year’s meeting, AIT Bioscience’s Quality Assurance … read the full article » »

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ELN as More than a Lab Notebook

ELN as More than a Lab Notebook Does your CRO use its ELN to its full potential?   Electronic laboratory notebooks (ELN) have been adopted across a wide range of scientific research and development companies. Typically implemented as an add-on to an existing system of paper notebooks, these systems have largely served as a “sticker … read the full article » »

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Tailoring ELN Workflows

  By: Ron Shoup   Setting up an Electronic Lab Notebook requires time, money, and most importantly, knowledge of the workflows that are performed in your laboratory.   As lab scientists, we sometimes overlook the inherent flexibility and numerous options that paper-based forms offer, whether for informal research or regulated analysis.  For example, graduate students can … read the full article » »

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Strategy for Designing Electronic Lab Notebook Workflows Both Flexible Enough for R&D and Comprehensive Enough for Regulated Work

By: Brian D. Beato*; April L. Pisek; Jessica M. White   Electronic laboratory notebook (ELN) workflows are typically designed for either research or regulated use. Documentation requirements for regulated sample analysis are unnecessarily comprehensive and rigid for free-form research. Creating and validating separate templates targeted for different uses is inefficient. Presented here is a widely applicable, strategy for … read the full article » »

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Efficient Strategy for Generating Method-Specific Workflows in an Electronic Lab Notebook

By: Brian D. Beato; Jessica M. White; and April L. Pisek   One common concern among scientists regarding implementing an electronic laboratory notebook (ELN) is that method-specific workflows (or templates) may either lack sufficient detail to be useful, or require repeated validation exercises for each new method. However, with the widely applicable strategy for designing ELN workflows outlined … read the full article » »

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Using Electronic Lab Notebook Functionality for Validating Electronic Lab Notebook Workflows

By: Brian D. Beato*; Timothy P. Grever; Laurel E. Branstrator   The use of electronic laboratory notebooks (ELNs) for regulated bioanalysis requires validation of numerous ELN workflows (templates). Presented here is a strategy for using common ELN functionality to validate workflows such that reviews are more efficient and comprehensive than for traditional software validation. The resulting electronic records … read the full article » »

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Accelerating Data Review in a Paperless Laboratory with ELN

By: Ron Shoup   The issues with paper:– Searching for information in paper systems– Printed methods and companion paper forms– Detecting disconnects between various papersystems (equipment calibration expiration vs. use in study)– Knowing when data is truly created in a paper system– Knowing whether results are built from secured and validated resources– Exhaustive QC checks to verify data … read the full article » »

Categories: Electronic Lab Notebooks (ELN), Quality Assurance and Electronic Laboratory Notebooks

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Auditing a Regulated Study Utilizing an Electronic Laboratory Notebook (ELN)

By: Abby K. Bousum and Laurel E. Branstrator   The steps for auditing always will be an exercise in puzzle-assembly –but now we have electronic tools (eTools) for assistance. Assembly of all the pieces that constitute a study occur within the laboratory, various electronic systems, and culminate within the ELN. The ELN serves as both a … read the full article » »

Categories: Quality Assurance and Electronic Laboratory Notebooks

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Automated and Validated Bioanalytical LC-MS/MS Data Analysis

By: April Pisek; Jessica White; and Michael Schneider   Bioanalytical projects require numerous types of calculations to be performed on LC-MS/MS data.• Manually transferring MS/MS data into an external spreadsheet program to perform calculations requires indepthsecondary review.• A more efficient workflow is presented here in which LC-MS/MS data is acquired directly into a LIMSsystem and automatically … read the full article » »

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Streamlining Bioanalytical Processes with QC in Real Time

By J. Rajarao; Brian Beato; S. Weiss; April Pisek; Laurel Branstrator; Tim Grever; and Ron Shoup   All bioanalytical (BA) LC-MS/MS labs strive to provide quality data in a timely manner. One important means of assuring adequate quality is performing quality control (QC) checks on the data and laboratory procedures. Traditionally, QC is performed after … read the full article » »

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