Robert Megagle Department of Ciwmlsby Cleveland State University Cleveland, OH 44115 Many analytical service laboratories are faced not only with increasing sample loads and testing demands, but also with growing record-keeping requirements. Reports to customers, legal archives, quality assurance records, good laboratory practice standards, regulatory oversight, workload justifications to management, and a host of other demands contribute to the paperwork explosion. When this paperwork is coupled with the logistical problems inherent in running a laboratory that must procesa thousands of samples. the stage is set for the acauisition of a laboratory information management system (LIMS). A LIMS is intended to help manage the daily workflow of the laboratory and act as a paperwork processor. Since 1983, when the functions and configuration of a typical LIMS were described by Dessy (1, Z), a number of evolutionary developments have occurred. This A/C INTERFACE will discuss some of these new developments and provide an idea of things to come. ScopeofaUMS In recent years, the term LIMS has hecome popular in sales brochures and is often used in a variety of ways that make it difficult to know exactly what is being described. Sometimes the term
is applied to any computer system that saves and manipulates laboratory data, even if it is from only a single instrument. In this discussion, LIMS will be used to describe a more encompassing system that includes some or all of the functions of test ordering, sample tracking, workstation management, results reporting, archiving, quality assurance, and the gathering and reporting of laboratory management data (3). A LIMS applies to all or at least major parts of the laboratory, as opposed to a 612A
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single-instrument system. A typical LIMS hardware configuration is shown in Figure 1; a typical logical organization is shown in Figure 2. Commercial UMS There are more commercial vendors in the LIMS field than ever before, and the producta they offer are powerful and sophisticated. Many of these systems permit a surprising degree of enhancement and adaptability, and they can he closely tailored to the needs of their owners. In the early years of LIMS, researchers often found it necessary to implement a customized system, using either in-house personnel or a contract software vendor, to achieve the features they wanted. Today, bowever, custom systems are needed only for special requirements or constraints, such as when there is an unusual lah-
oratory workflow waen existing resources must he used (4). Commercial systems cnn usually be delivered quickly and inexpensively, and the lahoratory benefits from a large user base, compatible accessories, future enhancements, and the flexibility usually found in commercial systems.
Enhanceduseof UMSdata One recent development in the LIMS field has been increased use of the data produced by the laboratory. Early
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LIMS merely correlated test results from different workstations and printed a report for the analyst. In many laboratories today, however, LIMS must do much more (5). The quality control lab. Consider a quality control laboratory that tests incoming raw materials. The LIMS is designed to allow the analyst to enter a set of specifications for each material tested. Each specification contains a list of the tests to be performed for that material and a range of acceptable test result values. When a sample from a new delivery is sent to the lab and logged into the LIMS, the material type is identified to the system. Then the LIMS automatically schedules the entire battery of tests given in the material specification. As each test result comes hack to the LIMS, it is compared with the acceptable high and low limits. If all the test results are within range, the new shipment is accepted. If any test result is out of hounds, the material may be rejected. In some cases, a failed test may cause the system to automatically schedule one or more repeat tests, possibly with fresh samples from the shipment. Because rejected shipments are costly to the supplier and may cause manufacturing delays for the buyer, it is important that the laboratory he certain of its results before rejecting a material. The pass/fail result for each shipment tested can he reported automatically to the receiving department and to the corporate management computers. Long-term records can he maintained hy the LIMS in the form of total pass/ 0003-2700189/0361812AI501.50/0 @ 1989 American Chemical Soclety
/ fail counts, number of passes since the last fail, and supplier rating (6). This helps the laboratory identify both reliable suppliers and those who need to tighten the quality control a t their facilities. Similar approaches can he adopted for quality control laboratories that test intermediate substances and final products. In these cases, sample collection is often the responsibility of the laboratory. The LIMS can he programmed to automatically generate collection lists and sample container labels, thus reminding the analyst when it is time to gather samples and to help the laboratory staff with that task. There are often very tight time constraints on quality control testing of intermediate and fmal products. If a process is starting to go out of specification, the plant needs to know quickly so that corrections can be made before whole batches of material are ruined. The LIMS can help speed the turnaround of results hy improved workstation scheduling and automatic electronic transfer of results from the lab to the plant floor. Another way to speed the turnaround of process control results is to locate the test sensors physically in the manufacturing stream. The instrument readouts can he placed near the sensor in the plant environment, or the raw signal can he digitized and transmitted to the laboratory where the data will be processed. Even when the test results are generated in the plant, they may also he sent to the laboratory and into the LIMS. The LIMS can then assist with quality control of the test methods, maintain the permanent archives, and correlate the results of numerous testing sites. Research projects. Many laboratories must support various ongoing project studies, which results in a series of similar samples that frequently require the same set of tests. There may he many samples, and they can arrive in the laboratory over a period of a few days or a few years, depending on the size, scope, and nature of the study. The individuals in charge of these studies are usually more interested in data comparisons, trends, and correlations with study parameters than they are in the results of any particular sample. A
st 8 workstali configuration
Flgure 2. Typical LiMS organization. heav m o w s ahow me wual analysls sequence. SMe ol me malor data 111es we shown insideme daC?Jmse. OuaIW mntml and managemMt r e w d functions m n i t u me main data flow thou$? he anaiyiIcaisequMcs.
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LIMS that can help the study personnel analyze the entire set of data will he more useful than one that treats samples as individual, disconnected items. To be useful in this application, the LIMS must have enough disk storage space to hold all sample information and test results for all the active studies underway within the organization. It must also be able to identify the particular study to which a sample belongs so that related data may be retrieved. For study correlations, the LIMS must also save important experimental parameters associated with each sample. This portion of the LIMS must he customized and should include a number of extra database fields in the sample records, along with software tools that allow retrieval based on these fields. Obviously the selection of these parameters depends heavily on the nature of the studies being conducted and is based on how study personnel would most likely be analyzing the results. Finally, a method must he devised to enter this information for each sample. For example, suppose a study involves collecting environmental samples from 10 different rivers at six different sites on each river every day for six months. The extra LIMS fields can he used to identify the river, the collection site on that river, and the date of collection. When the study data are analyzed, these fields can he used to retrieve and correlate test results by river, location, date, or any combination of parameters. For a laboratory supporting drug metabolism studies, the LIMS might be configured to capture the subject identity, time and date of drug administration, dosage, and other data needed for the overall study. A. L. Rapley of Shell Research Limited in Sittingbourne, England, has described a laboratory that supports field trials of agrochemicals (3. A protocol, which includes general information such as estimates of the number of samples that will be measured, the pests (insects, weeds, fungi) being targeted, field locations, duration of the study, crops used, soil type, and agrochemical formulation used, is entered into the LIMS for each study. When the samples are collected, the time and date of collection, recent weather conditions, physical observations, and other information are also entered. The sample context information is entered by field workers into battery-operated, hand-held microcomputers and is electronically transferred into the LIMS when the workers return to their home base. All of this information is saved with the sample records, along with the results of the lab tests. After results are accumulated for a study, they are ana614A
lyzed by various statistical routines. Another example of an applicationoriented system has been reported by Edward Subak of Pfizer, Inc. (8),whose laboratory develops analytical methods for new drugs and then analyzes each drug as it is tested for efficacy and safety. The methods, their correctness, and the studies must all he documented according to strict government regulations. Therefore, in addition to the usual LIMS requirements, this system is designed to prepare the regulatory documents, manage and document the analytical methods development, and define and measure the analytical performance over a long period of time.
LlMS in a regulated laboratory Laboratories suhject to government regulations (9, 10) have special concerns related to the development and operation of a LIMS system. In the United States, some laboratories must meet requirements of the Food and Drug Administration (FDA), the Environmental Protection Agency (EPA), the Occupational Safety and Health Administration (OSHA), the United States Department of Agriculture (USDA), and the Nuclear Regulatory Commission (NRC). The FDA, for example, requires laboratories that support the manufacture of drugs to meet regulations known as “Good Manufacturing Practices” (GMP), and lahoratories that collect information to demonstrate the safety of new drugs must comply with “Good Laboratory Practices” (GLP). Similar requirements exist within the EPA for laboratories that measure compliance for environmental discharge. Clinical laboratories that
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provide diagnostic data to physicians must follow “Good Clinical Practices” (CCP). Not all regulatory guidelines are equally comprehensive with regard to LIMS. When they are applicable, it is usually because the regulating agency has chosen to consider the LIMS part of the laboratory data-gathering procedure and therefore suhject to review. In general, the major impact occurs in the areas of system validation, documentation, data security, operating procedures, and personneltraining (12).The following information generally pertains to FDA requirements for GLP; similar concerns exist in other regulated settings. A year-long project involving 65 individuals from government, industry, and academia has produced a document (IO) that discusses these issues in detail for all types of computerized data systems in FDA-regulated laboratories, One major objective of government regulators is to assure that the data being gathered and used by laboratories subject to audit are accurate, consistent, and reliable. In those laboratories that have automated their data management, the LIMS is normally considered part of the data process. It usually sits between the data collection step (sample preparation and measurement) and the data presentation, review, and interpretation process. Evidence that data are not lost or corrupted while in the LIMS is required hy government regulators. Validation. Part of this evidence is assurance that the LIMS itself is correctly designed and implemented, which is acquired through Validation, a formal testing step designed to determine the correctness of a system. Validation is considered a distinct step during system implementation and is different from uerification, the testing and reviewing of each component of the system during development to he sure it is correct. When the LIMS is delivered from a vendor, the validation step may more typically he called acceptance testing. Whereas verification is usually done by the system developers, system validation is almost always the sole responsibility of the system users. Only they can make the final decision that the system works properly in their environment. The usual way to validate a system is to provide it with a set of known input data and observe the results that the system produces. Because it is not feasible to test all possible combinations of input, considerable care must go into the selection of the test data so that maximum confidence in proper system operation can he attained. It is also im-
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portant to perform the validation carefully, because government inspectors will likely he checking how well validation was carried out. The recommended procedure is to develop a validation plan, which is often started early in the LIMS proiect and refined as the project is carried out. It is developed from the 3ystem specifications, the design documentation, and the user manuals. The plan describes the various tests to he performed, the cest data sets to he used, and the ac. ceptahle results expected for those tests. The plan should do more than simply assure that good data entered under normal conditions are handled properly; it should find every possible flaw in the system. In addition to normal input, data sets should test the limits of the system and put the system under stress. They should include various kinds of improper input to check the system's error-handlingability. The validation plan should also describe the system that is to be tested, the environment in which ir will he operating during the tests, and the personnel who will carry out the tests. Any assumptions or limitations about the system or the validation plan itself should he indicated. Finally, the plan should state clearly what constitutes acceptable performance, and it should tell how m resolve any problems or errors that are uncovered during the validation. In some cases, the entire validation plan must he repeated after errors are fixed in other situations, only part of the validation needs to he repeated. When the system is deemed ready for the users, the Validation plan is enecuted as a final step before the system goes inm regular use. As the individual tests are carried out and passed, they are signed off. When all the tests have been passed, the system is declared to he validated and can he used for regular operations. Change control. In most applica. tions, the LIMS is continually heing enhanced with new methods, improved software, and additional features. Special procedures called "change contnil" need to be in place to ensure that the LIMS remains in a validated state after changes are made. The change control procedures will usually require that some or all of the validation tests he performed again in order to ensure that the enhancements did not corrupt unchanged parts of the system. In addition, there may be new tests t u demonstrate that theenhanced featuresof the system work correctly. The amount of testing that needs to be done depends on the nature andextent of thechanges made to the syjtem. Operating procedures. Even a
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properly designed LIMS can he used incorrectly. Government regulatory concerns, therefore, go beyond requiring a formal procedure to validate system operation. A written Standard Operating Procedure (SOP), which describes the policy and procedures to he followed for each activity, is usually required for each main activity or study in which the LIMS is used. Study SOPs normally go beyond the LIMS, describing the entire experimental plan of the study (experiment design, sampling, analysis methods, data processing, quality assurance, and interpretation strategy). SOPs for LIMS operations often include procedures for entry, storage, backup, archiving, and security of data. System security, disaster recovery, access, and maintenance procedures are also sometimes included. Training. Personnel training is important to the success of any LIMS and thus needs an SOP, indicating who will he trained, what subjects they will learn, and who will do the training. Different job functions require different training. For example, system operators and maintainers need to know more about the LIMS than individuals entering data and getting hack results. Data security. Regulatory agencies are concerned about the integrity of data within the system. I t should not he possible for information, especially raw data, to he corrupted or changed either accidentally or intentionally. Accidental data corruption should he guarded against hy appropriate computer strat-
egies such as error check characters, redundant backup data storage, and database transaction logs. It should only be possible to alter or ignore data known to be in error under controlled conditions. Normally, original data are never erased. New values are instead substituted with appropriate approval and sign-off, and the old values am retained with an indication as to why they were unacceptable. An audit trail thus exists so that it is always possible to review the history of any altered data. The LIMS should enforce these rules, and there should be an SOP describing the conditions under which data alterations are permitted. The definition of what constitutes raw data varies a t different sites. Sometimes it is the output of the primary laboratory instrument, even if the computer in that instrument has already done some data processing. Other times it is the digitized version of the original instrument signal. In chromatography, for example, the retention time, area, and height of each peak would be the raw data by the first definition. By the second defmition, the full chromatogram would be considered the raw data. Documentation. In a regulated laboratory, it is necessary to prove to a government inspector that the validation, change control, operating procedures, personnel training, and security requirements have been met. This is accomplished by maintaining complete and secure documentation. For system validation, the validation plan itself, the test data sets used,and the results obtained are all saved, along with the times, dates, and signatures of the responsible individuals who signed off each test. (The latter might take the form of a test log book.) There should be enough information in the validation archive to allow any portion of the validation plan to be repeated should questions arise a t a later time. A complete statement of the change control policy should be saved. Documentation of each system change should be maintained along with the results of the tests done to assure the system is still valid. Change control documentation may be maintained in the LIMS (12). The documentation should also include a complete copy of the SOPS,and there should be a record of all the changes that have occurred in the SOP documents durine the life of the system. Records should be keot on the individuals who received-training, the dates and nature of their training, and their job function insofar as it affects their use of the system. It should be possible to document that all system I
programming. Not any more. Now the Keithley Model 556 GPIB Measurement &Control System lets you interface a full range of transducers to the IEEE-488 bus. Mix any 10 signal conditioning modules from a library of over 25 specialized functions. Thermocouples, strain gages, digital and analog110, power control, frequency, motion . . . more. Simple yet powerful commands run with the language of your choice, and work with Mac, NEC, DEC, HE or an) 488 controller. On-board intelligence and memory let the 556 run as a stand-alone datalogger or process controller. Best of all, this power and performance start around $2500. Check it out, I‘DQ, with a toll-free call t u the PC Team at 1-800-552-1115. Or write: Data Acquisition & Control Division, Keithley Instruments, Inc., 28775 Aurora Rd., Cleveland, OH 44139.
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users were properly trained for the tasks they performed. General comments. The procedures and documentation described here do not fully guarantee that everything was done correctly or that the system is truly without error. They should, however, be sufficient to track problems and isolate responsihility should trouble become evident later. Although these procedure and documentation requirements may be expensive and time-consuming, they do enforce an accountability that tends to discourage shortcuts and other carelessness by the system developers or users. All information systems should go through a similar process, but it may be less formal and considerably less thorough without the pressure of regulatory oversight. Laboratory personnel must decide by some method that the LIMS is working correctly and is being properly used. In spite of the extra expense and bother, unregulated lahoratories should consider voluntarily adopting formal procedure and documentation policies similar to the regulations. It is a sound and dependable way of managing a complex LIMS operation.
lntematknal UMS conlerence The organization of the International LIMS Conference has been an important development in the field. The first conference was organized by Gerst Gibbon of the U S . Department of Energy’s Pittsburgh Energy Technology Center and attracted about 400 people. The papers, which dealt with various conceptual plans, design configurations, nifty features, and implementation stategies, were presented by both large and small laboratories for quality assurance, customer service, environmental monitoring, research support, and other functions. Although some of the systems described were designed and built in-house, others were purchased from commercial vendors. The audience varied from experienced system designers to novices seeking advice and knowledge. The second conference, led by Victor Zadnikof Alcoa, attracted a similar size and mix of audience. Sessions were devoted to ohjectives for a LIMS, managing a LIMS, LIMS and quality contrul, and LIMS and government compliance. Poster sessions and vendor presentations were also held. The Third International LIMS Conference will be held June 6-8, 1989, at the Anugraha Conference Center, Egham, Surrey, England, and will be the first European meeting. Sessions include LIMS: The Foundation of In-
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formation Technology in the Laboratory, LIMS and Quality, Strategies for LIMS Implementation, LIMS and Automation, Postimplementation Issues, and The Future of LIMS and Labs. The European meeting promises to be well worth attending. For registration details, contact: C. J. Jackson, Royal Society of Chemistry, Health and Safety Executive, Broad Lane, Sheffield S3 7HQ, England. Standardization activties An increasing number of vendors are offering LIMS products, and more lahoratories than ever are planning or implementing such systems. Many who already have a LIMS are planning for ita expansion or replacement, and instrument and laboratory equipment suppliers realize that their products must be able to work properly in a LIMS environment. More and more, the LIMS must be able to communicate with other data systems within the organization. In this context, most users and vendors realize the need for standards. With appropriate standards, growth of this technology will he more orderly and productive, and users will enjoy the convenience of more components and subsystems that will work properly when tied together. In an attempt to address the need for standardization, ASTM Committee E-31 on Computerized Systems created Subcommittee E-31.40 on Laboratory Information Management Systems with Victor Zadnik as chairman. Numerous issues have been identified, and three task groups have been established to address the most important of those issues. One task group is charged with developing common terminology for the LIMS field, and a second task group will produce a LIMS guide. This handbook is intended to provide authoritative information to beginners in the field as well as a guide to LIMS functions. It should help laboratory personnel develop functional requirementa for a LIMS installation. The third task group will address is-
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sues involved in communications with LIMS, inrluding instrumentLIMS in. terraces within the laboratory and communications with computer systemsandotherusersoutsideofthelab. oratory. The intention is to reach consensus on communication standards and protocols so that if adopted by vendors, plug-together compatibility ran be achieved. The consensus standards process works hest when there is wide representation of all users. Users, lab managers, in-house developers, and representatives from LlMS companies and instrument vendors are encouraged to send their comments to Victor Zadnik, Alcoa, Alcoa Techniral Center, Alcoa Center, PA 15069 (412.3372022).
Futuro directions LIMS technology is still experiencing rapid growth and significant innovations. User groups for established rommercial S Y S ~ ~ I Umeet S regularly to discuss problems, new features, and desired enhancements, and these groups are playing an important role because the suggestions frequently are used by the vendor to increase the power and usefulness of the next release. Among the trends that ran be expected are an inrreased use of interfaced instruments (13). More instruments will be able to arcept instructions from the LIMS, surh as which tests to run on each sample or which conditions to use for each test. The thorny problem of sample identification will be attacked with more instruments that can read bar codes. It is likely that local area networks will play an inrreased role, both for connecting instruments to the LIMS and for connecting the LIMS to other users and computers in the organization (14-17). When instrumentsaredeveloped with circuits and software for direct connection to s m d a r d local area networks, and when standard instrumentLIMS message protocols are defined, the interfacing problem is largely solved. A new instrument is plugged into the nearest network port, an enrollment procedure is performed at the LIMS, and the new workstation is up and running. A network configuration also serves the users of the laboratory service. They can enter orders for tests. see status information about work in progress, and obtain final results without leaving their labs and offices. Lab data can be passed into other computers in the system for project studies, corporate databases, more complex data analysis, or other business purposes. Artificial intelligence is likely to
have an impact on the LIMS of the future. Interpretations based on the combined results from different workstations will he performed within the LIMS. The knowledge to do this will he entered into artificial intelligence data structures by the professionals that are currently using the LIMS results to analyze problems, draw conclusions, and make technical and business decisions. An important driving force behind this scheme is the desire to capture such knowledge and experience so that it remains available to the organization even after the professional that learned it through a lifetime of experience has retired or left the company. The LIMS provides better recordkeeping functions, streamlined laboratory workflow, and improved performance through faster reporting, better quality control, and fewer mistakes. It also raises expectations ahout the level of service that can be expected from an analytical laboratory. Most testing laboratories that have not already done so will elect to install a LIMS in the next few years. Those who do not will find themselves falling behind increasingly enhanced professional and productivity standards that are made possible by this new technology.
References (1) Dewy, R. E.Anal. Chem. 1983,55,70A. (2) Dewy, R. E. A d . Chem. 1983, 55,
Gilmore, T.Amer. Lab. March 1988.34. (14) Megargle, R. G.; Sbecket, G.; Foulis, P. R Anal. Instrum. Comput. 1984,1(1), 6.
bauer-Seng, L. A. Anal. Instrum. Com-
P G I Goldber , R , So mani, K.; Gikore,T: Amer. La!. Septem: her 1987.98. (16) Scheil, W. A,; Hoffmann, K. M. Presented at the First International LIMS Conference, Pittsburgh, PA, June 23-25,
Press: New York, 1987. (5) Tpbin, F. Presented at the First Inter-
1987. (17) Cooper, C. A. Presented at the First
277 A. (3) Megargle, R. G.; Auping, J. V.; Green-
ut. 1984.1(2), 5. (4PMcDowell,R. D., Ed. Laboratory Informotion Manugement System; Halsted
(15) Berthron
International LIMS Conference, Pittsburgh, PA, June 23-25,1987.
national LIMS Conference, Pittsburgh, PA, June 23-25.1987. (6) Guy, W.; Irwin, R.;Bindell, J. Presented at the Second International LIMS Conference, Pittsburgh, PA, June 14-16, 1988. (7) Rapley, A. L.;
Jar+, D. Presented at the Second International LIMS Conference, Pittsburgh, PA, June 1616,1988. (8)Subak, E. J. Presented at the Second International LIMS Conference, Pittsburgh, PA, June 1&16,1988. (9)Wm, N. Presented at the Second International LIMS Conference, Pittsburgh. PA, June 1616,1988. (lo) Lepore, P., Ed. Computerized Data
Systems for Nonclinical Safety Assessment; Drug Information Association: Maple Glen, PA, 1988. (11) Mattes, D. C. In McDowell, R. D., Ed.; Laboratory Information Management System; Halated Press: New York,1987, n I__. 229 r.
Robert Megargle earned a Ph.D. f r o m Clarkson University in 1968. He has specialized in laboratory automation and instrument development since 1969. His earlier work i n instrumentcomputer interfacing has expanded t o include computer networks f o r the laboratory, LIMS,and laboratory robotics. ~~~~~~~~~
(12) Myer, R. S.; Faulkner,H.C.; Farment, H. 'Iesented at the Second Interm.I,,". tionall LIMS h l f i 19Conference, Pittsburgh, PA,
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(13) Janney, R.; Davis, C.; Brencovich, E.;
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