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choosing the right client

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The old Latin riddle 'Quis custiodet ipsos custiodes?' ('Who guards the guardians themselves?') is a good one for scientists and managers to ponder when they are considering the integrity of data in LIMS. Alex Crawford reports

In the canons of journalism, 'Dog bites man' is not news, but 'Man bites dog' goes on the front page. Sadly, the history of Laboratory Information Management Systems (LIMS) has many examples of suppliers selling expensive bespoke solutions inappropriate to the clients' real requirements to the point that it's a story hardly worth the telling. However, when a LIMS supplier acquires a reputation for success by refusing to sell to clients who don't meet certain criteria, that's rather different.

'There's so much potential LIMS business out there that we have to be selective about the clients with whom we're prepared to work,' according to Quality Systems International (UK) managing director Clive Collier. In that way, the company can avoid many of the pitfalls that have caused some 60 per cent of LIMS to fail, he claims.

QSI bases its choosy approach on the confident knowledge that the privately-owned company has had consistent success in getting its clients' LIMS live.

QSI has over 600 live sites in some 38 countries around the world, including 'blue-chip' corporations that have many of its WinLIMS installed. It has had some big global deals, such as those with pharmaceutical companies Boots and Merck, soft-drinks maker Pepsi, oil majors Exxon Mobil and Castrol, skin-care company Este Lauder, speciality chemical producers Rhodia and Rohm & Haas, gas and chemicals supplier Air Products and Chemicals, and fragrance, flavours and food ingredients manufacturer Quest International.

To assist in the implementation of LIMS, and to provide back-up service after installation, QSI has been using WebEx OnCall for the last two years. This browser-based, real-time solution offers clients an interactive service. It provides a secure way of showing them demonstrations and applications on their own PCs.

With WebEx, QSI has been able to solve seven out of 10 service enquiries immediately. It is security encoded so, although QSI can see the graphical images that the client is seeing, it does not have access to the client's data unless it has permission to do so. WebEx is said to be like having a technician on site and it reduces the time to resolve non-repeatable bugs dramatically.

EPA: Guardians of the environment
So to the riddle posed at the beginning of this article: 'Who guards the guardians?' The mission of the Environmental Protection Agency (EPA) in Ireland is to protect human health and to safeguard the natural environment - air, water and land - upon which life depends.

Maeve Quinn, EPA's Regional Manager in Monaghan, sees its work as vital in maintaining the clean, healthy environment of Ireland. She explained that, to achieve this, the Agency, among other things:

  • Licenses and regulates large/complex industries with significant polluting potential by means of Integrated Pollution Control (IPC) licences;
  • Licenses and regulates waste disposal and recovery activities, including landfill sites;
  • Monitors environmental quality, establishes environmental databases and publishes periodic reports on the state of the environment;
  • Licenses the contained use and controlled release of genetically-modified organisms (GMOs);
  • Licenses large fuel-storage installations;
  • Co-ordinates environmental research within the country;
  • Operates a national hydrometric programme; and
  • Advises public authorities on environmental issues, and assists and generally oversees the performance of local authorities in the performance of their environmental protection functions.

To accomplish its mission, EPA employs 242 people across the country. Among its staff are engineers, scientists and environmental protection specialists, working in its five laboratories (Castlebar, Cork, Dublin, Kilkenny and Monaghan). EPA operates a regional structure with headquarters in Wexford, five regional offices (Castlebar, Cork, Dublin, Kilkenny and Monaghan) and four sub-offices (Athlone, Letterkenny, Limerick and Mallow).

In 2001, the EPA as a whole analysed 23,176 samples for 503,032 determinations. 'In Monaghan, we put through 40,585 determinations (3,144 samples),' said Quinn.

The LIMS handles air, water and wastewater samples, which are collected from hundreds of sites around Ireland. At the end of 2001, there were 522 IPC and 101 waste licences issued, Quinn said, emphasising that each site might have several sampling locations. 'Most landfills have 10-20 sampling sites, while licenced industries can have several emission points. There are about 230 groundwater sampling locations, about 400 estuarine sampling points, over 3,000 river-monitoring stations and about 300 lakes,' she said.

EPA first started to discuss installing a LIMS in the early 1990s, and QSI's WinLIMS became the EPA's first official LIMS in 1999. Initially, QSI spent some time establishing EPA's requirements, by holding meetings and carrying out site surveys, before carrying out the installation and the training. On the whole, she was very positive about QSI's service. 'During installation and training they were very helpful. Our IT Manager was fully trained by them but, if he wasn't available to assist us, we could ring QSI directly and sort out any problems,' she said.

However, because queries with QSI are now dealt with through the EPA's IT Section, it can take longer. 'I asked our IT people what they thought of the service, and they are generally satisfied,' she reported.

'We find the LIMS an excellent way to manage the passage of samples through the laboratory - it helps ensure the correct tests are done on each sample and nothing is overlooked,' Quinn said. 'We installed the LIMS in July 1999 and would not go back to life without a LIMS.'

Boots: Guardians of health
As well as a well-protected natural environment, life also depends on good health, to safeguard which, pharmaceutical companies such as Boots, provide medicines. To maintain the reputation of the company as a safe source of pharmaceutical products (both over-the-counter and prescription), the Boots Manufacturing (BM) Quality System is designed to ensure that its products and services meet customers' requirements, according to BM Quality Assurance (QA) Manager Robert Cleave.

It's not easy, as there are stiff regulatory requirements placed on BM QA's data about the company's products, as recorded on its LIMS. 'As a company involved in the development, manufacture and supply of pharmaceutical products, BM is subject to regulatory inspection by government, e.g. Medicines Control Agency for the UK, and Food and Drug Administration for USA,' Cleave explained.

Regulators inspect (audit) facilities looking for evidence of control of operations, including the use of computer systems, such as LIMS, where these can affect the quality of products. 'Systems that can affect the safety, purity or efficacy of medicines are required to be validated,' he said. 'This involves the system having been developed by a quality assured process, generating documentary evidence that the system functions according to its agreed specifications, users being trained and operating according to documented procedures, and, once live, being properly change controlled.'

This means that BM QA ensures that all aspects of the business operate in compliance with quality-related regulations and standards governing the products that BM manufactures, packs and tests, including release of raw materials, bulk ingredients, manufactured intermediates, packaging components, stability testing and release of manufactured finished products. The medicines, cosmetics and toiletries include well-known brands, such as Nurofen, Optrex, Strepsils, and Clearasil, many of Boots's own brand medicines, and products manufactured for other pharmaceutical companies.

It's very demanding, as BM QA carries out more than 100,000 tests a year on some 19,000 samples taken in six laboratories: Microbiology; Stability; and four Analytical. These serve the Beeston, Nottingham, site, where there are five factories, and the Airdrie site.

The tests involve a wide range of different analytical techniques: high-performance liquid chromatography (HPLC); atomic absorption (AA), inductively coupled plasma (ICP), near infrared (NIR) and X-ray fluorescence (XRF) spectroscopy; X-ray diffraction (XRD); gas chromatography (GC); ion chromatography (IC); titrations; wet chemistry; assays; limit tests; identifications; and dimensional measurements.

Not surprisingly, with such complexity, a LIMS was seen as the way forward. 'The LIMS was required to replace a manual record-card system,' explained Cleave. 'The drivers were improved control, cost savings and tighter lead times.'

QSI was selected to establish the LIMS requirements, which it did with BM's ITT department and by conducting site surveys. The installation required servers, PCs, scanners, printers and label printers.

Cleave has a very positive view of QSI's service during installation and post-installation. 'QSI understands the customer's business needs and is flexible and responsive,' he declared.

The answer to the riddle
In The Hitchhiker's Guide to the Galaxy by Douglas Adams, the answer to the question 'What is the meaning of life, the universe and everything?' (as given by a computer specifically built for the purpose) was... '42'. For these two organisations, the answer to the question 'Where do we procure the LIMS to protect everything upon which life depends?' was... 'QSI'.

Criteria for choosing clients

Criterion 1: QSI will install a WinLIMS system only if its own staff perform the site survey and write the specification, because the company is sceptical about the worth of specifications drafted by some independent consultants. Although apparently comprehensive, they often do not deal with the real situation in the laboratory where the unfortunate staff may eventually have to work with an inappropriate LIMS.

The NPL Best Practice Guide 'Selection and Use of LIMS' was written with a view to encouraging all laboratories to look at the benefits of LIMS. But, even with the help of such a Best Practice Guide, it is not enough for the management of a laboratory to draw up its own specification, however thoroughly managers do their audit to define what they want from the LIMS.

For QSI, the first step is for two of its own professional staff to go in on a walk-through survey. They will go through the whole cycle of the laboratory's operations to build up a complete picture and talk to each department in turn. One person reviews the workflow, the instruments in use, the reports required, security, system redundancy, service needs and communications. QSI has many solutions to bring to the table.

Criterion 2: QSI will review the proposed specification with the client and fine tune it until they agree on the ultimate blueprint for the LIMS.

The the absence of an agreed blueprint can leave supplier and client with different perceptions of what they are expecting, and of what is expected of them. Clients must agree training and implementation objectives before QSI will take on a project.

Criterion 3: QSI will explain the human resources that the client needs and will make them available. Because a LIMS is seen as improving the efficiency of the client's laboratories, there is a danger that the client will seek to save on human resources and training. The company insists that all its clients make available adequate human resources, establish open communications and adopt realistic timescales.

Criterion 4: QSI will insist that project management is in place. Often the daily demands on laboratory managers are such that they do not have enough time or personnel to allocate to the project management required for implementing a LIMS. Aware of the potential trouble that failure can cause, QSI also offers project management. Without project management to insist that timescales are set and deadlines are met, the project could lose impetus.