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Scientific Expertise & High Performance = Winning Combination for Sponsors

If you’ve been involved in outsourcing projects to bioanalytical CROs for any length of time, you’ve probably sorted the CROs you work with into two groups: the ones who are really good at cranking through samples as long as you can provide them a robust method, and the ones who can solve the complex problems … 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 » »

Categories: Electronic Lab Notebooks (ELN)

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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 » »

Categories: Electronic Lab Notebooks (ELN)

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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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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 » »

Categories: Quality Assurance and Electronic Laboratory Notebooks

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Implementation of an Electronic Laboratory Notebook in a CRO Environment – May 25

By: Ron Shoup   January 2009: Build a new bioanalytical CRO with a vision unencumbered by legacy constraints. Key goals:•Paperless, completely electronic data-no conventional forms or lab notebooks•Catching errors in real time•Quality audits by exception•Sample preparation by robotics•LIMS providing instrument controland data acquisition•Automated document generation   To read more see the attached pdf.   Implementation … read the full article » »

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Implementation of an Electronic Laboratory Notebook in a CRO Environment

By: Ron Shoup  Key goals:•Paperless, completely electronic data-no conventional forms or lab notebooks•Catching errors in real time•Quality audits by exception•Sample preparation by robotics•LIMS providing instrument control and data acquisition•Automated document generation    To read more see the attached pdf.    Implementation of an ELN in a CRO Environment   Share this with your colleagues.Tweet

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