Suite of tools can be used to modify this commercial off-the-shelf (Cots) laboratory information managment system (Lims) as business and/or laboratory needs evolve
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, says Autoscribe.
These tools enable it to meet user requirements without the need for custom programming or esoteric, proprietary scripting languages.
Lims requirements and business needs change throughout the lifetime of a system, and Matrix Lims is designed for change.
Matrix Lims is fully configurable, but based on a standard product core.
It comprises a suite of Lims configuration tools designed to facilitate the smooth, fast implementation of a Lims completely designed to meet 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.
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 categorised 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) in 1994 to publish the first Gamp guidelines and to run training seminars.
Gamp software and hardware categories category 1 operating systems 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 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 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 hundreds 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 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.
Autoscribe is involved in the development and supply of software for Lims (laboratory information management systems) and the scientific laboratory and business markets.
Autoscribe says it pioneered the use of innovative configuration tools within the Lims market and today its Matrix Plus Lims software is seen as the industry standard to which others aspire, it claims.
Autoscribe offers a wide portfolio of products and services including systems for Lims, sample tracking, instrument calibration and maintenance, stability testing, customer complaints management, support management system, ISO9000 protocol driven training records management and resource planning.
Founded in 1981, Autoscribe is a privately owned UK company.
Worldwide it is represented by a network of business partners in regions including the USA, Canada, France, Benelux, Germany, Indonesia, Switzerland, Scandinavia and Australia.
Its organisation includes a dedicated team of developers, technical support specialists and sales and marketing professionals.
Customers include analytical, oil, pharmaceutical, biotechnology, chemical, and consumer products companies as well as academic research institutes, hospitals and many others.
