on the paper trail
One of the most notoriously unfulfilled promises of the computer age has been the idea that the advent of electronic technology would usher in the era of the 'paperless office'. The reverse has happened - computers mean that we generate more paperwork in the office, not less - with the result that the very phrase 'the paperless office' has become something of a standing joke. It is a brave move on the part of several LIMS companies therefore, to come up with a modified version of that promise. Offices may be drowning in more paper than ever before, but Laboratory Information Management Systems (LIMS) will create the 'paperless laboratory'.
In various guises, the paperless laboratory has been a theme running throughout the period that is the subject of this LIMS review for Scientific Computing World. Of course, other important trends are also visible, most notably how it has become almost conventional for LIMS companies to develop their interests in informatics for the life sciences. The period has also been marked by some major new releases.
LabWare exemplifies two of these themes. In announcing a new release of its software, the company explicitly pledges that its LIMS 5.0 will be a vital link in delivering on the promise of the paperless lab. According to LabWare, the configurable system design also allows a lab to spend less time installing a system, and more time applying it to specific information needs.
But the company's CEO, Vance Kershner, stressed the new theme: 'LabWare LIMS 5.0 is an important step toward achieving a paperless lab. Now that electronic records are fully upon us, a LIMS platform must offer new levels of responsiveness.' As always, vital aspects of electronic record-keeping are security, tamper-proofing, and the provision of an audit trail. The new release offers integration with Adobe ePaper Forms, allowing laboratories to replace notebooks and paper-based documents with interactive electronic forms created by, and managed exclusively within, the LIMS. Electronic signatures can be obtained and verified across the global enterprise through a secure digital workflow application.
The US Food and Drug Administration's regulations for electronic records and signatures (known as 21 CFR Part 11) are driving developments in this area and LabWare has adopted an Open Systems format using Public Key Infrastructure and Digital Certificates. The company believes that this technology will enhance collaboration among product teams because digitally signed electronic documents will be less dependent on the applications that created them, but the authenticity and integrity of the data will be maintained.
Enhanced security and compliance with 21 CFR Part 11 are the main features of the new release of LabWorks from PerkinElmer Life and Analytical Sciences. The new LabWorks LIMS offers a centralised point of authentication to simplify the process of making critical laboratory data secure.
Other companies are writing variations on the paperless theme. Laboratory Data Solutions Limited believes that the launch of its new product, Labsform, 'brings the paperless laboratory a step closer'. Labsform has been designed to operate alongside existing LIMS as a software application for routine data recording, filling a gap in electronic data recording and management. Users can convert existing paper-based recording systems into electronic templates. The application enables secure forms to be generated that accept laboratory data input via PCs and/or laptops, and it can be directly linked to electronic devices such as laboratory balances. The package then allows data to be interrogated, tabulated, checked, approved, stored and archived to comply with the latest regulatory guidance and legislation. Labsform has been produced by Terrington Systems Limited, in conjunction with laboratory scientists from York Bioanalytical Solutions.
More modestly, but perhaps sensibly in view of the unhappy precedent of the paperless office, QSI does not quite promise a paperless laboratory but offers 'a less tiring paper chase'. The company's Document Control Module is designed to integrate essential documents into any LIMS application. For example, the module can make instantly available the Standard Operating Procedures for a rarely used method, when a sample specification is detected that requires this method. Similarly, if a particular type of sample presents specific risks or requires special handling precautions, the appropriate Health and Safety data sheet could be attached automatically to that sample. In this way, the Document Control Module can create and maintain a convenient central repository for all the documents used by the laboratory.
Integration in a slightly different sense is visible with the new Nexxis Information Integration System from Labtronics. Nexxis combines instrument interfacing with user definable interactive procedures, automation of standard operating procedures and the ability to communicate with databases and database applications. The result is a fully integrated solution that provides analysts with one central access point for all of the information they need to control, monitor, and document the proper execution of each analysis. Nexxis includes the security components that are necessary to meet the requirements of 21 CFR Part 11.
The other theme - informatics solutions for the life sciences - is exemplified by both Applied Biosystems and LabVantage. Both have seen that life science laboratories are in danger of drowning in data as powerful, high throughput instruments became more commonplace.
As noted in the previous LIMS review, Applied Biosystems has developed a strategy not only of enhancing its LIMS for tracking, analysing and managing data to the standards required by pharmaceutical manufacturing and QA/QC laboratories, but also of going out to the R&D laboratories by offering Rapid Integration Solutions (RIS) - combining software and professional services. An integrated informatics solution supporting analytical research and development will frequently take the form of several lab management systems of differing complexity operating under the same umbrella to support the whole range of research and development.
For pharmaceutical manufacturing and QA/QC, Applied Biosystems' core product is its SQL*LIMS, built on Oracle RDBMS using the Oracle Developer 6 4GL tool set and providing a scalable Client/Server architecture. Version 4.1 has recently been introduced offering: streamlined user accounts, audit and electronic record/ signature configuration and monitoring; plus enhancements to the audit trail and electronic signature capabilities that allow more precise mapping of a laboratory's workflow.
In the research and development arena, the company's Rapid Integration Solutions (RIS) programme combines software with professional services. In a proteomics laboratory, for example, the RIS could integrate sample handling, sample analysis (such as 2-dimensional polyacrylamide gel electrophoresis), isotope-coded affinity tag experiments, gel image analysis, instruments (such as gel cutting robots and mass spectrometers), bioinformatics tools for managing and analysing mass spectroscopy (MS) data, sequence and protein expression data, post translational modifications and other types of data coming from protein identification and characterisation experiments. All MS and sequence data can be stored in a single database, with all gel or ICAT reagent, MS and protein ID/expression information stored in a results' management system, to be analysed and visualised with standard statistical packages.
Interestingly, the company is not going it alone in this area. It has, for example, signed an agreement with geneticXchange to resell the latter's discoveryHub software through its RIS programme. discoveryHub combines IT and life science applications for real-time data integration of virtually any life science data source. Together with MDS/Sciex, it has also recently signed an agreement to integrate its Pro ICAT software with DecisionSite for Functional Genomics, the software program from Spotfire Inc. for protein expression analysis.
Other LIMS companies, too, see a rosy future in the life sciences. LabVantage, for example, nowadays explicitly describes itself as a 'provider of life sciences LIMS' as well as of enterprise LIMS. The US National Cancer Institute (NCI) recently signed a software and services agreement for NCI's Core Genotyping Facility, to use the company's Sapphire software to perform high throughput genotyping analysis.
NCI will use Sapphire to manage and track details of every sample from the DNA provider through to their Core Genotyping Facility Units. The software will assist the NCI in discovering and validating single nucleotide polymorphisms (SNPs) as part of the SNP 500 cancer re-sequencing effort - a programme to find distinctive cancer-related 'signatures' in DNA. To achieve this, the NCI's researchers have to develop genotyping assays, to track and genotype DNA samples - all of which generates a requirement for sophisticated data management. To increase operational efficiency, the Sapphire software system will also be used to track costs of all samples and genotypes processed.
The life sciences' theme is discernible too in the latest release of Thermo LabSystems Nautilus 2002 LIMS. According to Peter Yendle, R&D director at Thermo LabSystems: 'Its release is a real endorsement of our decision to appoint a Biotechnology Special Interest Group. This multinational group includes selected Thermo personnel from sales, support services and development that were tasked with collectively determining and prioritising functionality and providing field testing.' Release 2 offers increased flexibility in the processing of microtiter plates, and a new Result Browser for the presentation of plate and aliquot results. A series of features to support the processing of results and tests at the plate level is aimed at laboratories involved in high throughput screening and experimentation.
In the upgrade to its other product, SampleManager 2002, the company's enterprise LIMS, Thermo LabSystems has struck out in a rather more independent direction, offering improved capabilities for data analysis. A new software component, Calculation Builder, allows users to simplify the creation of complex calculation formulae, to create calculations across different sample types, and to use previously saved data-searching criteria in their calculations. An extensive library of mathematical functions is included.
The picture that seems to be emerging from this review, then, is the promise of less paperwork and more maths in the QA/QC laboratory while, almost independently, offering better management of the flood of data being produced in the discovery labs. Increasingly, customers - the big pharmaceutical companies for example - want to integrate the two ends of their production process, and to be able both to feed forward to the process line data from the research lab, and to feed information back from formulation and quality control to the research laboratory. This is a huge task of integration, not only of data but also of different ways of working. The role of LIMS in facilitating this integration will doubtless feature in future reviews in Scientific Computing World.