Quality Assurance and Electronic Laboratory Notebooks Archives - AIT BioscienceAIT Bioscience


Category Archives for Quality Assurance and Electronic Laboratory Notebooks

AIT Bioscience Presents at 14th Annual Indiana Life Sciences Summit

On October 9th and 10th, AIT Bioscience employees had the opportunity to attend and present at the 14th Annual Indiana Life Sciences Summit in downtown Indianapolis. This summit is presented by BioCrossroads and highlights and celebrates innovations in life sciences from Indiana and around the world through both business and scientific tracks.   This year’s … read the full article » »

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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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The People at AIT Bioscience have been Busy

Jasmine Roach passes Registered Quality Assurance Professionals Exam. In late April, Jasmine Roach, Quality Assurance Specialist, sat for the Registered Quality Assurance Professionals Exam for GLP. Jasmine passed this exam on her first try. This certification is highly regarded by quality professionals internationally. As of December 2016, only 620 people worldwide had successfully passed this exam. Jasmine … 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 » »

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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 » »

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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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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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A Systems Integration Approach for Fully Electronic Regulated Bioanalysis

A Systems Integration Approach for Fully Electronic Regulated Bioanalysis By: Brian Beato    Integrating LC-MS/MS Instrumentation and LIMS•Tracks sample receipt and analyses•ISR tracking and reporting within routine analytical runs•TSQ Module™ provides seamless control of Waters UPLC®and Thermo TSQ Vantage™ MS/MS•Compiles run data, MS/MS conditions, instrument control files all in one bundle for review and archive. … 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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