LIMSzine
The following column highlights an interview with Dr. Jo Webber , as
well as LIMS reports of interest.
Auditing a Client/Server LIMS Vendor
Report on LIMS User Satisfaction
New LIMS Study
New Hewlett-Packard Analytical Products Brochure
Validation audits are a time-consuming, paperwork-intensive, high-priority
task for organizations operating in a regulatory environment. For many,
they are a necessary evil. At the recent LASF conference in Nashua, NH,
in October 1995, numerous presentations highlighted various aspects of validation,
from how to prepare for a validation audit to how to perform one. Research
Director for LabWare, Inc. (Wilmington, DE), Dr. Jo Webber gave one of those
presentations. She covered not only how to prepare for and perform a site
inspection, but also the nuances of how to assess a Client/Server (C/S)
LIMS. This interview highlights some of the issues she detailed.
Gillespie: You mentioned a "Client/Server Curve Ball" during
your presentation. What is that?
Webber: C/S LIMS often throw a curve ball into the validation process.
Most LIMS suppliers have an accredited quality system in place that was
created around the development of minicomputer or PC based systems using
traditional systems development. With C/S technology now being the industry
standard, most LIMS vendors are rewriting their products to use this technology.
However, the development environments used to create successful C/S products
utilize object oriented methodologies, and these new tools require an entirely
different approach to systems development. One example of the differences
between the old and new development environments is the issue of prototyping.
In a traditional character cell development environment, it is difficult
and time consuming to create prototypes, which discourages their use. Hence
the software development cycle often goes directly from the development
of the functional specification (in paper form) to the code. The main disadvantage
of this approach has been the age-old issue of "I know I agreed to
the functional specification, but this is not what I wanted"; i.e.,
the customer is often disappointed by the end result since they have only
seen a paper description of what will be produced.
With C/S development, it is much easier to develop prototypes and let the
customer 'see' the system before completion. During the development lifecycle,
the functional specification is typically briefer but followed by a series
of prototypes for the customer to review during development, thereby ensuring
that the end result is favorably received.
Therefore, the main difference between character cell and C/S development
is that the waterfall method of designing code, which went from analysis
to design to code to test, no longer applies. With C/S development, the
design phase is longer and contains more prototyping. It goes from analysis
to design and then code, but repeats the design and code cycles with several
prototypes before final test. It is critical that the quality system accurately
reflect the development methodologies suitable to the new development environments
being used.
Gillespie: How do these different development cycles impact the auditing
process?
Webber: The auditing process is the same, but you need to be more alert.
In particular, look for two things. First, that the LIMS vendor has a set
of quality procedures that are sensible and acceptable to you. And, second,
that the LIMS vendor follows those procedures.
ISO 9000 reflects the way you work, so the mode of working should be and
is different for the two types of LIMS, and should reflect the mode of development.
Some LIMS vendors have incorporated the new method of development, most
haven't. So look for more prototyping when auditing a C/S LIMS. If the vendor
is not using this capability to its full advantage, they are not developing
the LIMS in the best way. The reason you need to make sure they are using
the correct process is because if they are not, you are just going to get
a poorly developed system.
To this end, ask for references. This is going to be difficult because every
C/S LIMS is really version 1.0. The company may call it version 4.0, but
it's not. The numbers leap from a character cell system to a C/S system.
And as you now know, C/S is a complete re-write. You have to recognize that
any references are probably using character cell systems.
Gillespie: What are some specific items the audit team should look for
during a C/S LIMS audit?
Webber: Again the development process is key, so inspect QA and software
development in-depth. Specifically, review administration, the QA SOPs and
the development SOPs, and maintenance and change control. In particular,
review the following:
1.) If you require the LIMS to link to other in-house systems, then the
linkage will need to be validated. Ensure that the LIMS has the ability
to communicate with the outside world in a structured manner.
2.) Ensure that the development procedures are available, adequate, and
followed.
3.) Check the internal training records. Look for training on C/S development
not only for the programmers but also for the support and implementation
staff.
4.) Take a well-balanced audit team that includes an applications expert,
an Information Technology (IT) person, and a QA/QC person. It's key that
the IT person have an understanding of C/S development.
Compare the difference between C/S and character cell development to the
difference between assembling cars by hand versus using an assembly line
-- it's a completely different method of development. With C/S, there are
far more rules and it's more structured. And it isn't particularly obvious
from the end result how the product was created. The only way to absolutely
tell the difference between the two LIMS is in how the development process
was documented.
Report on LIMS User Satisfaction
Analytical Consumer, a monthly newsletter that covers laboratory instrumentation
user satisfaction, offers a comprehensive report on LIMS. The LIMS Report
includes two in-depth surveys of LIMS owners; advice for planning, specifying,
implementing and validating computer systems; case histories, and more.
The report is available free with a one-year subscription, or for US$150
in North America and US$160 elsewhere. For details, contact Analytical Consumer
at (508) 369-9079.
New LIMS Study
Strategic Directions International (SDI) has published another detailed
LIMS study. Labs on LIMS: Customer Satisfaction Among U.S. & Canadian
Users shares LIMS managers' views and experiences regarding their current
LIMS as well as new systems they are considering for purchase. Interestingly,
the top three products differed from the top three suppliers. The 56-page
report costs US$695. For details, contact SDI at (310) 641-4982.
New Hewlett-Packard Analytical Products Brochure
Hewlett Packard has just published
a brochure that provides an easy-to-read yet comprehensive overview of HP's
entire line of analytical chemistry products, systems and services. It covers
industry-specific solutions, liquid and gas chromatography, spectrometry,
integrated information management, and more. For a free copy, contact HP
at (800) 227-9770 X1788 and ask for Literature #5964-3661E.