The “Monster LIMS” of the past could be the dinosaurs of the Lab Industry. These huge under takings have given the LIMS (Laboratory Information Management System) acronym a bad name. Many companies have spent hundreds of thousands or even millions on a product that is so complicated and resource draining that it sometimes never gets off the shelf.
Since the early 1990’s we in the environmental lab industry have seen many changes in the laboratory operation. The huge contract laboratories have combined, absorbed or just plain disappeared. Midsize labs became giants or also vanished with the environmental dollars. The small laboratories have been under the watchful eye of government, big brother, and anyone else that pays the bills.
Innaphase has been acquired by Thermo. What’s next?
August 29, 2004 - Automating Document Change Control in FDA Regulated Environments: Increase Efficiency, Ensure Compliance and Improve Profitability
The purpose of document change control systems is to ensure that manufacturers build products that are safe and reliable. Good Manufacturing Processes (GMP) presume that both the process and documentation directing the process follow pre-approved methods, and any change to these methods is both restricted to authorized personnel, and tracked for future review. All FDA-regulated companies are mandated to have a document change control system.
ARUP Laboratories owned by the University of Utah (UU) is a leader in the laboratory testing market space. Serving clients in all 50 states, ARUP offers an extensive menu of over 2,000 diverse medical laboratory tests and test combinations, with a particular expertise in the more exotic analyses. Operating 24 hours a day, the company processes over 20,000 specimens of blood, body fluid, and tissue biopsies each day. Although ARUP maintains super human testing efficiency and turn around time, their success hasn’t happen overnight.
Today there is much written and talked about when it comes to “Web Services”, but what does it mean to you and your laboratory data management systems. This article will address a specific technology that makes “Web Services” possible and useful to the laboratory.
August 16, 2004 - The Impact of the Guidance for Industry Part 11, Electronic Records, Electronic Signatures – Scope and Application
This document will interpret and discuss the impact of the Guidance for Industry – Part 11, Electronic Records, Electronic Signatures – Scope and Application which was released as a final guidance for industry by the FDA in August of 2003.
A driver can be a very effective tool for transferring data from a source to
a destination because they are specifically designed to work within a very
clearly defined and fixed application. However, in the real world of
instrument interfacing each laboratory has unique needs and requirements
that are continually changing. In that environment the better choice is a
flexible solution that can be readily configured to meet each laboratory’s
This article discusses an approach to planning and assessing the implementation of a System in an environment that is regulated by the U.S Food and Drug Administration (FDA).
July 18, 2004 - Equbits product suite helps High-Throughput Screening (HTS) scientists develop accurate predictive models to support virtual screening efforts
Equbits product suite helps HTS scientists develop accurate predictive models to support virtual screening efforts. Based on a common and open platform, Equbits Insight™ sets new standards in predictive modeling accuracy for HTS prediction.
Over the past few years the Andrology Lab at Hammersmith Hospital has been deeply involved in the development of an electronic Sample Tracking and Laboratory Management software system that is now commercially available.
The Expanding Role of Mass Spectrometry in Biotechnology covers the basic concepts in mass spectrometry as well as advanced topics including protein identification/protein structural analysis, carbohydrate and oligonucleotide analysis.
June 29, 2004 - Practical Interfacing in the Laboratory: Using a PC for Instrumentation, Data Analysis, and Control
This practical text describes how to use a desk-top computer to monitor and control laboratory experiments.
Instrument Interfacing has been the talk of the lab informatics for several years now. Many a times interfacing is the key subject when a LIMS project is initiated and during the finalisation of the project it is normally pushed to phase 2 of the project.
Meeting regulatory compliance requirements, decreasing the time to market for new products and upholding the highest standards of quality are key objectives for any pharmaceutical company. In an increasingly competitive industry, how well a company achieves these objectives can be critical to their on-going success.
June 22, 2004 - 21 Cfr Part 11: Complete Guide to International Computer Validation Compliance for the Pharmaceutical Industry
21 Cfr Part 11: Complete Guide to International Computer Validation Compliance for the Pharmaceutical Industry
June 22, 2004 - Current FDA Thinking on 21 CFR Part 11: Effects Upon IT Vendor Strategies [DOWNLOAD: PDF]
This IDC study examines the trends and events in the pharmaceutical and medical device industry as a result of 21 CFR Part 11 and of the FDA’s latest regulatory guidance issued on February 20, 2003. It will explain Part 11 at a high level and describe current FDA thinking related to Part 11.
Choosing the Right Instrument Interfacing Technology In the early days of LIMS interfacing, technology was limited and interfacing solutions tended to be inflexible. Advances in interfacing technology have provided users with more flexible options to choose from.
Most chemical inventory software will help to eliminate some of the paper
work involved in managing laboratory inventories, but they don’t provide any
real control over your inventory management procedures or the accuracy of
the inventory data. Find out how to guarantee the accuracy of your inventory
data and take full control over inventory management procedures – and spend
less time doing it…
June 14, 2004 - Good Laboratory Practice Regulations (Drugs & the Pharmaceutical Sciences, Vol 124)
Fully updated and revised to include the latest information since publication of the first edition in 1989, the Second Edition of this highly praised reference covers all aspects of the Food and Drug Administration’s (FDA) Good Laboratory Practice (GLP) regulations and techniques for implementation