| Decisions by laboratories around the world to implement Chromatography Data Systems (CDS) are primarily driven by the need to maximize efficiency and boost productivity. Huge savings can result from the use of a fully functional CDS in quickly and accurately converting raw chromatographic data into results, information and then knowledge for better and more timely decision making.
Modern CDS now also provide full application support for compliance with FDA Ruling 21 CFR Part 11 (electronic records and signatures). On March 20 1997, the FDA published its final rule (21 CFR Part 11) on the acceptance of electronic records, electronic signatures, and handwritten signatures executed to electronic records. The Rule became effective on August 20 1997 and establishes criteria for the FDA's acceptance of these items as the equivalent to paper records and handwritten signatures executed on paper. The Rule applies to electronic records and electronic signatures kept as a requirement of the FDA regulations. All companies in all industries regulated by the FDA have, or will have, to change or assure their working practices to remain compliant with the Rule. Moreover, there is a moving target since current interpretations of Part 11 compliance for CDS are likely to change as a result of future FDA evaluations and inspections.
The importance of CDS' addressing the compliance requirements of the biopharmaceutical industry is explained by the increasing importance of the life sciences sector to CDS vendors. The adoption of new methodologies, such as high throughput screening, have led to an increasing number of samples being analyzed. The pharmaceutical discovery industry is predicted to be the sector of most growth in the foreseeable future. Industry observers forecast the pharmaceuticals industry will spend more than $111 million per annum on CDS in 2001, of a total market worth of $468m and growing.
Integration is a key means of automating procedures and, therefore, today's CDS support data acquisition from all leading chromatograms, along with full bi-directional control. Chromatographers favor systems that are independent of instrument type or manufacturer, ensuring they can benefit from their choice of the latest and best technology for the task. Additionally, CDS are required to interface with LIMS so that chromatography results can not only be securely sent to the LIMS on authorization, but sequences of samples prepared in the LIMS can be imported to it, either manually or automatically.
The market for CDS is often divided for analysis into workstation (standalone) and client/server systems. According to the most recent report, the workstation segment accounted for 46% of the market. As one would expect, the number of workstation CDS installations is greater than the number of client/server implementations. However, due to the higher value of client/server systems (average price over $70,000), this segment is considered the larger market. The cost of a client/server system can range from two times the cost of a workstation system to close to 10 times the cost.
Atlas from Thermo LabSystems is one CDS which was developed to address the integration, automation and productivity improvement requirements and is acknowledged as a market leader in the mid to large scale (16 – 800+ channels) market. Thermo LabSystems serves Atlas customers in industries such as; pharmaceuticals, biotechnology, petrochemicals, chemicals, environmental, food & beverage, cosmetics, forensics and contract testing.
Designed originally as a client/server solution for networked laboratories with multiple users and channels, Atlas has not, however, been widely deployed in the small systems market (1-4 channels).
Thermo LabSystems' exhibit at the recent Pittcon conference saw the launch of a significant technological innovation designed to redress this disparity and make Atlas available for more cost-effective deployment in even single workstations and scaleable from one to thousands of channels. This is called A2D, a revolutionary analog-to-Universal Serial Bus (USB) adapter that connects directly to the analog output of the chromatograph.
The development of Atlas
Thermo Labsystems has been developing and supporting computing solutions for chromatography since the early 1980s. Its previous generation CDS include well known brands such as XChrom and Multichrom. In 1998, Atlas was released as a 32-bit system with a design focus on delivering laboratory productivity by adapting to laboratory workflow and offering improved ease of use. Its development has benefited from a Joint Application Development program involving leading chromatographers and their IT peers from organizations such as Dupont Pharmaceuticals, Aventis, GlaxoSmithKline and AstraZeneca, to ensure the system mirrors the way chromatographers actually work.
Atlas is comprehensive in its functional coverage and includes an integral Report Writer that allows the generation of report templates, using the point and click of a mouse, from within the Atlas application. This means that obtaining the right report is simple and reproducible, eliminating the need to export data into third party packages, thereby easing validation.
The most recent version has been developed and optimized for the Microsoft Windows 95™, 98™, NT™ and 2000 operating environments (including Windows Terminal Server) and uses the Microsoft Office™ style guide for its user interface.
Aventis Animal Nutrition complete CDS migration to Atlas
In February 1999 and with Y2K hysteria looming, Aventis Animal Nutrition made the decision to migrate from Multichrom to Atlas with the aim of completing migration within eight months. Such a timeframe represented a significant challenge in terms of project management and control, for both Aventis and Thermo LabSystems.
Aventis Animal Nutrition is the second largest supplier of nutritional feed additives for animals and poultry, with an estimated value of approximately $5billion. The Commentry site, in the Auvergne region of France, employs more than 800 people and was formerly part of the Rhone Poulenc Agriculture organization. Thermo LabSystems has enjoyed strong corporate relationships with the constituent parts of Aventis for many years prior to the Company's foundation at the end of 1999, including the Pharmaceutical and Crop Science businesses.
Leading the migration project was Aventis' Henri Bourbon. Mr Bourbon has system managed Multichrom since it was introduced in the early nineties and has been it's representative on the Atlas Joint Application Development (JAD) program since 1996.
While achieving Y2K compliance was a key objective, Aventis was aware of the new benefits that Atlas would bring to its users. Among the key benefits anticipated were increased productivity brought by its Microsoft Windows user interface and the improved flexibility in data processing. Aventis' acceptance criteria for Atlas were as rigorous as they would have been evaluating a CDS from a totally new supplier, including minimum requirements on ease of use, ease of system management and system performance levels.
At Commentry, their chromatography system is time critical and operates seven days a week, dealing with approximately 32,000 individual results and 7,000 analyses per month, so disruption during the migration had to be kept to an absolute minimum.
The migration involved quite a cultural change for Aventis; moving from character cell VAX terminals to Windows PCs. New COMPAQ servers were purchased and installed to carry up to 512 Mb of memory, compared to the 24 Mb capacity of the old VAX machines. Modification to the connections with the 16 chromatography servers was also required. In total, the Atlas implementation involved 54 channels of chromatography. Multiple levels of security were set up, including a third level where data is automatically acquired on a second server in the incidence of a crash of the main server.
Throughout the project, Thermo LabSystems consultants were on hand helping with the installation, providing technical assistance in the roll-out and training. With Thermo LabSystems' assistance, Mr Bourbon and his team achieved their objective within the aggressive timescales they set themselves and have now have a modern CDS which has gained speedy user acceptance.
Aventis' next big IS project is to link Atlas to SAP's R/3 QM module where Atlas results will be uploaded through Thermo LabSystems SM-IDI module, with an objective of going live before the end of 2000. Having met their original deadline for the migration, Aventis can have confidence that, in partnership with Thermo LabSystems, this integration project will be equally successful.
The A2D and DataServer
The A2D is a new, compact, high specification acquisition and control unit, based upon Universal Serial Bus (USB) technology. The A2D takes the analogue detector signal, digitizes it, and transmits the digital signal to the host PC via USB. It is a small footprint device and therefore suitable regardless of how crowded the laboratory may be. It replaces the multi-channel Atlas Chromatography Server, yet is able to co-exist upon the same network. It communicates the signal to Atlas via the host workstation PC (or Data Server) to provide true ‘Plug and Play' durability and fault tolerance, protecting against loss of data should a unit fail.
Features of A2D include:
- Bi-polar functionality with software selectable data input range, from +/- 1V, +/- 2V, +/- 5V & +/- 10V. This allows Atlas to handle baseline signal drift with ease, eliminating the requirement for reruns to be required for those that drift below zero
- 24-bit resolution Analog-to-Digital (A/D) converter provides outstanding resolution for integrating small trace peaks in the presence of larger components
- Base acquisition rates of 250Hz, 500Hz &1KHz
- Constant digital display via a 2x16 alphanumeric LCD of voltage output, status of detector signal and sample identification
- 8 TTL inputs and 3 contact relays to permit easy valveswitching
The new Data Server unit provides a 'server' service to A2D's and uses embedded Windows NT in order to enable it to run unattended without user interaction. The Data Server also introduces a superior level of fault tolerance and redundancy to networked data systems as well as providing a gateway to the network for the laboratory instruments. As part of the network, the Data Server connects directly and locally with up to 4 digital channels and, using tiered USB hubs, can expand to support as many channels as the technology permits. This presents users with a high degree of flexibility and scalability.
Regardless of the instrument type or manufacturer, instruments can be added quickly and easily to Atlas. Utilizing Thermo LabSystems' A2D and DataServer technologies, Thermo LabSystems supports data acquisition from all of the leading laboratory chromatographs.
Until this year, laboratories that required a single workstation CDS were unable to deploy Atlas cost-effectively and therefore missed out on all the features that made Atlas a leading CDS, particularly its instrument independence. With the availability of A2D and DataServer data acquisition and instrument control technologies, Thermo LabSystems has brought all the productivity and cost-saving benefits of Atlas well within the means of even the smallest laboratories conducting chromatography.
Thermo LabSystems was delighted to receive two nominations at the Pittcon Editors' Awards 2001 for Atlas release 2001 and A2D.
About the Author
Tony Johnson is the Director of the Data Systems Group at Thermo LabSystems, based at its Altrincham UK headquarters. Tony has both a B.Sc. and a PhD in Mathematical Physics and has worked for 12 years in sales and marketing roles for Thermo LabSystems worldwide.
*An edited version of this article was published in the August edition of International Labmate's Software Computing Solutions.
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