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.
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
specific needs.
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).
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.
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.
21 Cfr Part 11: Complete Guide to International Computer Validation Compliance for the Pharmaceutical Industry
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...
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
A step-by-step, how-to reference and guide, Practical Pharmaceutical Laboratory Automation explores the processes needed to automate the majority of tasks required in research today.
Presenting a comprehensive design of alternative collection systems, both conventional and innovative, for the treatment and disposal or reuse of treated effluent, this text focuses on decentralized systems and smaller plants (less than 5 Mgal/d)
Now in its 20th edition, this text presents significant improvements of methodology and enlarged its scope to include techniques suitable for examination of many types of samples encountered in the assessment and control of water quality and water pollution.
