n Monitor/Lab. Inf: Manage 17 (1992) 305-307 305

Monitor

m News

New TIB for Beckman Lab ~ana~erT~. LlMS

A new technical information bul- letin (TIB) gives details of instal- lation and operation qualification validation services for Beckman Lab Mansgerm LIMS.

The installation qualification (IQ) service sys~mati~lly tests the hardware, wiring, electrical supply, and other physical equip- ment comprising the laboratory computer environment to ensure that each component of the com- puter automated laboratory sys- tem (CAL@ is installed to recom- mended standards. The results of IQ testing provide a well-docu-

mented ‘base state’ that is useful the intended use of the CALS sys- in system validation and for fu- tem; stress-testing of all security ture revalidation efforts resulting mechanisms; collections of test from system evolution. The tech- cases developed to challenge the nical information bulletin begins full range of functionality on the with a brief definition of IQ serv- specific configuration; and high- ices versus operational qualifica- quality, accurate d~umen~tion. tion (OQl services and an over- The TIB outlines the setup of an view of the entire process. It goes OQ protocol, the execution of the on to examine each aspect of the OQ plan, the role of the Beckman IQ validation procedure, includ- Quality Assurance Department, iug focused testing, documenta- and the value of automated OQ tion and approval. services in revalidation.

The operational qualification validation service is an integrated set of actions performed on site to verify and document the perform- ance of configured CALS system software on previously qualified hardware. OQ validation services consist of an extensive survey of

To obtain a free copy of these TIBs, please contact Beckman In- struments, Inc., 90 Boroline Road, Allendale, NJ 07401, USA. Tel.: (+12011818-8900.

m Meeting Report

Sixth International LtMS Co~ferenee Pittsburgh, PA, USA, 9-l 1 June 1992

The Sixth In~r~tional LIMS Conference was held in Pitts- burgh, 8-11 June 1992. Confer-

ence chairman, Dr. Robert Megar- gle (Cleveland State University) and programme chairman Rich- ard Mahaffey (Eastman Chemical Company) put together an excel- lent conference, consolidating and expanding on the themes of the five earlier conferences and focus- iug the sixth conference on topical issues in laboratory information

management, although the open- ing of the conference was some- what subdued by the untimely death some weeks earlier of Earl Cooper.

As with previous Pittsburgh Conferences, those who arrived on the scheduled opening day found that they had already missed a couple of informative and edu-

306

cational sessions on Monday. Joe Golden’s LIMS Primer course was attended by around a hundred delegates, while around a further hundred, perhaps more ex- perienced LIMS initiates at- tended the ASTM workshop on ‘Standards impaling on LIMS’ involving presentations by Jim Powers of Wyeth-Ayers& on the ‘ASTM E31 guide for LIMS’ and Robert Uleski of Boehringer- Mannheim on ‘Standards for validation of LIMS’.

The concerns of the clinical LIMS users, who have been in need of interface standards for some years now, were covered in Leon Wolf+4 presentation on clini- cal instrument interfaces and Steven Howlett’s report on pro- gress in setting a standard for bar-coding for use with clinical analysers.

Rick Lysakowski of DEC then brought the audience up to date with the progress of the ADISS Analytical Information Model - analytical data interchange and storage standards.

On Monday afternoon, the delegates were invited to learn more about GALP - good auto- mated laboratory practice - the extension of GLP to automa~d analytical procedures. US En- v~onmeu~l Pro~ction Agency personnel explained that GALP had arisen as it became clear that GLP auditors lacked guidance from the EPA in assessing compli- ance of automated systems to GLP principles. The logical way in which the GALP principles of co~dentiality, integrity, data security and audit trail gave rise to specific GALP recommenda- tions was covered by Rick John- ston, and certainly excited consid- erable interest from the audience.

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The simultaneous sellout at- tendance at the LIMS Primer course and the ASTM and EPA presentations clearly demon- strated the wide range of LIMS experience among the delegates, and provided a clear challenge for the conference proper, in catering for such diverse applications areas and depths of knowledge.

The first session on Tuesday dealt with ‘LIMS and information technology’. Ray Dessy (Virginia Polytechnic Institute) got the con- ference off to a tho~ht-provoking start with his argument that it was necessary to network to- gether the analytical, research, office automation and production aspects of i~ormation ~chnolo~, and that such integration was no luxury - it is essential to sux- vival, Education in LIMS was the theme of Dr. Robert Merrer whose Western Co~e~icut State University was one of the few to teach LIMS as part of the under- graduate chemistry curriculum. Mark Ifshin then outlined the benefits of LIMS in a clinical stu- dies environment, identifying a 50% ~provement in turn-round time of clinical studies protocols through implementation of ICI’s in-house Study Manager soft- ware. The session continued with papers which recognised the dy- namic nature of the laboratory and the need for systems to adapt to the changing requirements of business and end-user. It ended with a superb presentation on ADLAS - an integrated UNIX- based computer system inte- grated with a PC-LAN computer system and developed by the Sumi~mo Chemical Company to support their research require- ments from planning an experi- ment, through data acquisition, to

analysis and reposit-~ndliug, in the process graphs, tables and images.

Tuesday morning also saw the opening of the poster session, and a new departure for the Pitts- burgh-based International LIMS Conference, an integrated equip- ment exhibition.

The afternoon session ex- amined ‘Experience gained ac- quiring a LIMS’ with advice on user involvement when selecting a LIMS; the justification for LIMS in terms of proven improvement in the staff productivity, princi- pally in the performance in verifi- cation and validation of calcula- tions procedures. Randy Hice (DEC) looked at the reasons why LIMS implementations fail, listing faulty decision-ma~ng cri- teria, no workflow analysis, lack of user involvement and miscon- ceptions both among users and management of what a LIMS would do. Hand-in-hand with this went a lack of appreciation of what had to be done to support such a major project. Randy finished with a plea that all in- volved should try to separate pre- implementation, the reality from the wish-list, and reminded us that there are a hundred ways of making a LIMS fail, but only one or two ways of making it work. The rest of the session continued the theme of a systematic assess- ment of LIMS software prior to the purchase decision,

Session 3, on the topic of ‘LIMS - a foundation for quality’ began with Bob McDowall (Well- come Research) who identified the factors critical to a successful laboratory au~mation project - a strategic plan, a knowledge of the tools available, and a clear understanding of the require-

1 Monitor/Lab. A$ Manage. 17 (1992) 306-307 307

ments - in particular, success criteria must be defined before the start of the project. Key points for success included: a single in- dividual to coordinate the project, synergistic teams to implement systems, and the positive man- agement of change.

The session covered stand- ards-based approach to LIMS development, and ended with per- haps a typically ~al~ornian con- cern where Tim Long (Amgen Inc.) looked at the human issues in the ma~gement of change. He identified that only 2% of person- nel would be classed as ‘innova- tors’ - the rest have to be en- couraged.

A short, but worthwhile, fourth session under the headline ‘LIMS - fact or fantasy’ featured presentations by Peter Schilling ollcoa) who pointed out that, since the 197Os, there had been no correlation between the amount spent on computing, and a company’s productivity, and went on to point out that time spent on assessment prior to im- plemen~tion was well worth- while because, in his words “LIMS is like a marriage - it will change your life, it lasts for a long time, and it is difficult and expen- sive to get out of’.

Doug Kirkwood @EC) listed current LIMS issues - require- ments for global comm~ications; integration of the desk top en- vironment and management of the multi-vendor environment, and reduction of complexity, to- gether with increased functional-

ity - and listed the likely re- quirements of ‘Lab 2000’ inciud- ing voice operation, image secu- rity, and electronic notebooks.

After the oppo~u~ity for dele- gates to participate in an at- tended posters session, the confer- ence resumed with a session on clinical applications with Kenneth Ellich (University of Oklahoma Health Sciences Center) discuss- ing elimination of the paper trail within the laboratory, and methods of making laboratory re- ports more easily understood by clinicians. Jay Jones (Gelsinger Clinic) discussed the network~g necessary to link two hospitals and forty general practitioners of- laces in rural Pennsylvania, and the session continued with Dave Chou (Cleveland Clinic) talking about the problems of sample trading and turn-round of a 17 million test per annum workload.

Session 6 covered regulatory issues with pre~n~tions by Paul Lepore (FDA) on GLP regulations and assessment of compliance of the LIMS systems; Joseph Solsky on the US Army Corps of En- gineers’ development of a data management standard, whose function is to provide the Corps with a uniform mechanism for processing, reviewing and using chemical data and Sandy Weinberg (Weinberg Associates) who e~imat~ the cost of valida- tion as 4-14% of system cost.

The final session, on stan- dards, functionality, and quality control, featured Michael Rank (H-P Instruments Division) who

reminded us that all LIMS will require significant cus~misation “to fit your o~ani~tion~. He went on to outline H-P’s response to this requirement for flexibility - a language-based approach to Lab Management Systems. Joe Liscouski (Laboratory Automat- ion Standards Foundation) then identified the need for a ‘labora- tory automation engineer’. The need arises because the tradi- tional approach of chemists and programmers learning a little of each other’s discipline is expen- sive and prone to problems of mis- ~ders~nding.

The Sixth LIMS Conference continued the traditions of the previous conferences by discuss- ing current topics in LIMS and the reviewer’s discussions with individual delegates suggested that the organisers had fairly successfully bridged the often dif- ficult gap between novice and ex- perienced LIMS practitioners. The Sixth LIMS Conference Com- mittee has given both the 1993 European conference next June at the Anugraha, and the next Pitts- burgh-based conference, in June 1994 under the chairmanship of Jeff Miller (Miles Inc.) a hard act to follow.