Quality Assurance and Electronic Laboratory Notebooks Archives - AIT BioscienceAIT Bioscience


Category Archives for Quality Assurance and Electronic Laboratory Notebooks

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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