Product category:
Measurement and Quality Software and SPC
News Release from: Autoscribe | Subject: Matrix LIMS
Edited by the Manufacturingtalk Editorial
Team on 05 August 2005
Configurable COTS with LIMS
Autoscribe's Matrix LIMS is a GAMP Category 4 Configurable Software Package.
Autoscribe's Matrix LIMS is a GAMP Category 4 Configurable Software Package The hidden value and true benefit of Matrix LIMS lies in the power of its unique configuration tools
This article was originally published on Manufacturingtalk on 4 Jan 2006 at 8.00am (UK)
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Unified LIMS configuration for desktop and web use
The unique OneTime Configuration tools with Matrix LIMS automatically create a unified LIMS configuration for both desktop and web use.
Harmonizing LIMS and ERP/MRP systems
Matrix LIMS is designed for change enabling companies to easily meet their existing user and business needs and to regularly revisit new ways of working.
These tools enable us to fully meet your user requirements without the need for custom programming or esoteric, proprietary scripting languages.
LIMS requirements and business needs change throughout the long life-time of the system and Matrix LIMS is designed for change.
Matrix LIMS is fully configurable, but based on a standard product core.
Further reading
LIMS configuration for the nuclear industry
Matrix Rutherford is the latest configuration of Matrix LIMS, specifically designed for the nuclear industry and related test laboratories.
Solution for all water testing laboratories
Laboratories as well as new facilities being commissioned can benefit the most by installing a new configuration of the very successful Matrix LIMS product, called 'Neptune'.
Pharmaceuticals company bolts on with LIMS
As the UKšs oldest independent pharmaceutical company, William Ransom specialises in manufacturing liquid pharmaceuticals and natural extracts for the healthcare and food sectors.
Matrix LIMS comprises of an elegant suite of LIMS configuration tools designed to facilitate the smooth, fast implementation of a LIMS completely designed to meet your current and future user requirements.
This suite of tools can also be used to modify the LIMS as business and/or laboratory needs evolve.
A "wizard" style interface and use of a LIMS configuration knowledgebase helps the vendor, and later the system administrator, create and/or modify end-user screens.
Other tools facilitate documenting the configuration and providing configuration control.
Successful LIMS do not stand still and our unique next generation suite of LIMS configuration tools deliver significant business benefits throughout the lifetime of the system.
COTS is a term used to describe "Commercial Off-The-Shelf" software packages and some hardware systems.
COTS systems are manufactured commercially and are then tailored/configured for specific uses.
Almost all software fits into the COTS category such as operating systems, word processors, office products and email programs.
Such software applications are configured for use for a specific function without altering the basic program.
COTS packages were further categorized by GAMP in the Good Automated Manufacturing Practices guide for Validation of Automated Systems.
GAMP was started in 1991 by a group of UK pharmaceutical experts who subsequently partnered with ISPE (the International Society for Pharmaceutical Engineering) in1994 to publish the first GAMP guidelines and to run training seminars.
GAMP Software and Hardware Categories Category 1 Operating Systems Category 1 covers established, commercially available operating systems.
They are currently considered to be validated by use for any project in eg a pharmaceutical manufacturing environment.
Upgrades to the operating system could potentially lead to retesting of applications run on the operating system.
Category 2 Standard Instruments, Micro-controllers, Smart Instrumentation Category 2 covers instrumentation that is driven by non user-programmable firmware such as some standalone laboratory instrumentation, barcode scanners and weighing scales.
Such systems may be configurable and the configuration is usually recorded in the equipment Installation Qualification (IQ).
The IQ needs updating if the revision of firmware is changed.
Category 3 Standard Software Packages Category 3 covers 'canned', out of the box, widely commercially available configurable packages such as Microsoft Excel, Lotus 1-2-3 and other spreadsheet packages.
Such packages have usually been installed in multiple industries/environments and their sales often run into 100s of thousands if not millions of copies.
There is currently no requirement to validate such software packages, however new versions are usually treated 'carefully' and risk assessment should be performed prior to upgrades being performed.
Validation effort is typically focused on the application of the spreadsheet package eg to perform specific calculations such as those used in Impurities Analysis, Dissolution Testing, Bioassay Method Validation, Calibration Bracketing etc.
Category 4 Configurable Software Packages Category 4 covers configurable packages and includes some LIMS products and Chromatography Data System (CDS) products, Data Acquisition packages (SCADA), Manufacturing Execution Systems and MRP packages.
The system and platform should be well known and mature before being considered as Category 4 otherwise Category 5 applies.
Category 5 Custom or Bespoke Systems A complete life-cycle model approach for the development, testing and validation must always be completed for all custom built or bespoke systems. Request a free brochure from Autoscribe ...
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