Since August 1997, Rule 21 CFR Part 11 has provided criteria under which the US Food and Drug Administration (FDA) will consider electronic records to be the equivalent of paper records, and electronic signatures equivalent to traditional handwritten signatures. Requirements of this rule include the need to demonstrate the integrity of electronic records, validity and non-repudiation of electronic signatures, and auditing of changes to records.
Even though the implementation of electronic records that are compliant with 21 CFR Part 11 would greatly reduce the flow of paper and the need for physical signatures, there has been a reluctance to convert from paper records.
According to a recent poll conducted by NuGenesis Technologies Corporation, 58 per cent of those surveyed believe that the ability to share data is the most significant benefit of a paperless environment. Increased collaboration, and the ability to share data, greatly speeds up the drug discovery process, for instance, because it allows the entire organisation to view others' experiments and data.
However, most scientific laboratories are still paper-based, with experiments being archived in notebooks. Almost 80 per cent of those surveyed cited cost and resources as major obstacles to implementing a paperless laboratory. Nonetheless, 63 per cent of the respondents were confident that their organisation would become paperless in the next five to seven years. Most laboratories are using a mix of software systems because they are unaware of any comprehensive software systems that are compliant with 21 CFR Part 11 and have electronic signature capabilities. Over 50 per cent of the participants' systems were missing some Part 11 technical control functionality, and 23 per cent were using systems that did not provide them with electronic signature functionality.
Michael McGuinness, NuGenesis Technologies' president and chief executive officer, said: 'NuGenesis Technologies has understood the impact of the regulation since its inception in 1997 and our software was created with the regulation in mind. With our understanding of 21 CFR Part 11, we've created a website to better educate the scientific community, and to be a resource on this critical issue.'
Another company that has launched a website on 21 CFR Part 11 is Laboratory Data Solutions (www.labsform.com) to support their 21 CFR Part 11 friendly software application, Labsform. FAQs about Labsform have been included. It is envisaged that the website will be further expanded this year, to provide more detail regarding 21 CFR Part 11 issues, together with a discussion group facilitating debate amongst existing and prospective users of Labsform.
As part of the whole 21 CFR Part 11 compatibility, NuGenesis has recently launched version 6 of its Scientific Data Management System (SDMS). The optional Compliance Module for Microsoft Office applies the technical controls required by 21 CFR Part 11 to Excel spreadsheets, Word documents, and PowerPoint presentations, without changing the native MS file format. The system also has the capacity to deal with future data requirements, like XML, and its modular construction gives it a scalable architecture, enabling deployment at a single laboratory or across a global enterprise. During recent performance and scalability testing, 9.75TB (terabytes) of data were successfully captured in one week (equivalent in size to the entire printed collection of the US Library of Congress).
One feature of the system is that data can be viewed without using the instrument software that created it, facilitating collaboration by research members and managers. The system seamlessly integrates all data sources within the existing IT infrastructure, exchanging data with other common systems and software tools such as statistics and visualisation programs.
Michael McGuinness commented: 'With version 6 we provide revolutionary enhancements to our solutions for the lab and the enterprise that enable broad data management across the entire life cycle of scientific data and easy integration within the existing technology structure. This solution meets the needs of scientists, IT, regulatory and business management.'
A web-based platform integrates within existing technology, without disrupting current systems. Automated archival and audit trail capabilities for security and compliance simplify backup for disaster recovery of critical scientific data, without disrupting scientific workflow (with full validation protocols and services).
The company has just signed an agreement with IBM to co-market the SDMS with IBM eServer and TotalStorage solutions. The combined offering is designed to help life sciences companies, including drug makers, access and utilise research data more effectively throughout the drug discovery, development and manufacturing cycles. A link has also been formed with LabWare and its Electronic Analytical Worksheet, so that users of SDMS can now create worksheets that include selected and derived results from the LIMS.
The FDA rule is sometimes viewed more in relation to the pharmaceutical industry's needs, but it is as well to remember that the food industry is also highly regulated and a significant market for LIMS systems.
Analytical Information Systems (AIS) has just released a new revision of the stability pre-scheduling module for laboratory staff in the pharmaceutical and food industries, who can now manage their stability trial and results entirely by LIMS.
In the pharmaceutical industry, the stability of medicines and packaging is of key importance. In the food industry, shelf-life studies and packaging stability is paramount. Unstable medicines, and food with very short shelf-life, can be very costly to the manufacturer.
The new stability pre-scheduling module allows samples to be pre-registered onto the LIMS for planned release at predetermined times. The AIS LIMS organises the work protocol by informing lab staff of what resources are required for the stability study, what needs to be done and when to do it.
Still with food, LabVantage Solutions of New Jersey has signed an agreement with WestFarm Foods to supply LabVantage Sapphire LIMS. WestFarm Foods will be using Sapphire to provide customers with access to data via Sapphire's browser-based, 'virtual user' licences. WestFarm Foods will implement LabVantage Sapphire with a centralised Microsoft SQL server database at its headquarters in Seattle, Washington, and will be integrating Sapphire with its Oracle CPG information management system.
Customers will be given virtual user licences that will enable them to submit and review quality samples via secure Internet browser connections that expand data access beyond the laboratory's traditional four walls.
'LabVantage has clearly become the leading laboratory software solution provider for food and beverage manufacturers by offering a secure, browser-based solution that can scale and perform,' said Scott Deutsch, vice president, global marketing, LabVantage. Other organisations that use Sapphire include Excel, Northern Foods, Tropicana, Foremost Farms, Jones Dairy, Kerry Foods, ConAgra, Unilever and Danone.
Applied Biosystems, on the other hand, sees a rapidly growing market for its systems in forensic science. The current explosion in DNA profiling means that automation of DNA fingerprinting is now standard, and the amount of data that forensic laboratories have to analyse and manage has become unfeasibly large. Forensic laboratories, of course, are legally bound to maintain the 'chain of custody' of evidence and so must be able to track and document everything precisely, to ensure that evidence used in court is not compromised.
The company organised its First European Forensic Informatics User Meeting in Amsterdam in January, attended by scientists from both European and non-European forensics laboratories. It has produced a version of its Rapid Integration Solution (RIS) for Forensics, which offers experimental design facilities and DNA Databanking, in addition to the usual features of workflow and data management. Applied Biosystems believes these latter capabilities can be easily applied to other aspects of forensic science, such as analytical chemistry and toxicology.
Whether the LIMS application is in the food industry, pharmaceutical sector, or elsewhere, the interface between a LIMS and the instrumentation in a laboratory can be the weakest link in the installation. The RS 2000 instrument interfacing module from QSI is a one-off solution to instrument interfacing, unique in that it is fully user-configurable, and designed and supported by the LIMS supplier. Because RS2000 is an integral part of the WinLIMS installation, bi-directional communication between WinLIMS and the instrument is much easier. Sample data queues can be set up in WinLIMS and transferred, in the right format, to the PC that is controlling the instrument, avoiding the lengthy setting up of individual sample queues for each instrument.
This can dramatically improve efficiency - for one QSI client it reduced the time to process a sample from seven hours to 35 minutes. One PC can interface to several instruments, saving on hardware costs. Interfaces are configurable by the user, and fully supported by QSI, so flexibility and expandability are readily available as instruments are replaced and procedures change.
And if you need to access all this data from your mobile, Accelerated Technology Laboratories (ATL) could have the solution. ATL's Sample Master Pro LIMS software is now available, bundled with the Toshiba Magnia Z310 wireless mobility server to provide flexible laboratory data management.
Interfaces, but this time language interfaces, are a preoccupation of PerkinElmer Life and Analytical Sciences, which has demonstrated a new version of Labworks that can be easily modified to provide a native language interface in nearly any language.
The Labworks ES (Enhanced Security) system now provides one of the most comprehensive language capabilities on the LIMS market, the company says, including native versions in French, German, Italian, Spanish, Japanese and Chinese. The software is one of the first on the market to support double-byte characters for true Asian language support.
Finally, Thermo LabSystems has announced that new analytical quality control (AQC) functionality is now available as part of the latest version of its Nautilus LIMS.
AQC is a technique for monitoring the accuracy of analytical methods, through the use of control samples processed by laboratory instruments. Such information provides analysts with confidence that results acquired from actual samples are correct. The new AQC functionality in Nautilus is expected to generate particular interest from laboratories where samples are taken from many diverse sources - for example, an environmental lab testing samples from various points along a river using a wide variety of instruments and analytical methods.
However, in a move resembling that of PerkinElmer's decision to integrate LIMS within a newly created 'life and analytical sciences' division, Thermo LabSystems and Thermo Galactic have been merged to form an informatics division within the parent company, Thermo Electron. The name, Thermo Labsystems, has now ceased to exist.
Thermo Galactic had expertise in the development and support of desktop spectroscopy systems, and this is now combined with the LIMS, Chromatography Data Systems, and long-term data archival aspects of the former Thermo Labsystems.
Marc Casper, president of the Life and Laboratory Sciences sector of Thermo Electron, said: 'In the last few years, Thermo Electron has made great progress in transforming itself from what was a disparate array of businesses into a single, focused company. It is significant that our informatics business is the first of our businesses to embrace the Thermo Electron brand in this way, given the role their products play in integrating so many of our customers' laboratory operations.'
