Electronic Lab Notebooks (ELN) Archives - AIT BioscienceAIT Bioscience


Category Archives for Electronic Lab Notebooks (ELN)

AIT Bioscience Offers New Screening Level Assay

AIT Bioscience Offers New Screening Level Assay     A fit-for-purpose approach to bioanalytical assay support balances intended use of data with regulatory requirements and budgets. FDA regulated studies (GLP Tox or Clinical) require the use of a fully validated bioanalytical assay. However, for non-regulated studies sponsors often ask themselves, and their bioanalytical CRO partners, … read the full article » »

Other Categories: Ligand Binding Assays (LBA), Screening Assay



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Is Your ELN Lab Optimized for Faster, Better Data?

Bioanalytical contract research organizations (CROs) have been adopting electronic lab notebooks (ELNs) for several years now, but few ELN labs deploy a validated, fully-integrated platform. As we recently wrote for Contract Pharma, the jump from an electronic sticker book to a truly paperless workflow can revolutionize a lab’s efficiency and prevent errors before they happen. … read the full article » »



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Electronic Raw Data and the Use of Electronic Laboratory Notebooks

By Ron Shoup, Ph.D.   Computer-based electronic data capture has been the standard in chromatography and mass spectrometry data systems for over 20 years.   About 15 years ago, FDA recognized the widespread use and convenience of electronic data for regulatory submissions and implemented 21 CFR Part 11 to broadly describe the requirements for the collection, … 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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A Paper-Free Fully Regulated Bioanalytical Assay Validation of Fentanyl in Human Plasma

By: Brian J. Engel; Michael R. Pugh; Barbara J. Carel; and Ronald E. Shoup   A fully validated bioanalytical method for fentanyl in EDTA human plasma spanning 5.00 – 5000 pg/mL was generated in a completely paperless laboratory. The model presented illustrates the application and interaction of multiple electronic laboratory systems to execute and document a validation … read the full article » »

Other Categories: LC-MS/MS Methods

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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 » »

Other Categories: Quality Assurance and Electronic Laboratory Notebooks

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Going Paperless: Implementing an Electronic Laboratory Notebook in a Bioanalytical Laboratory

By Brian Beato; Laurel Branstrator; Barbara Carel; Brian Engel; Timothy Grever; April Pisek; Michael Pugh; Michael Schneider; Ronald Shoup; and Jessica White   The aim of any bioanalytical laboratory is to deliver quality data fast. Proper implementation of an electronic laboratory notebook (ELN) can play a major role in accomplishing these goals by both increasing laboratory … read the full article » »

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