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Quality Control and the University Application of a COTS LIMS

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Written by Robert Benz, Sales & Marketing Director at Khemia Software

Proper quality control is critical for the production of any valid laboratory data, whether regulatory or research. However, how this quality control is applied may vary greatly depending upon the application. In the regulated environmental community, set rules are applied to the type, limits of and number of quality control samples. These rules are well established and published by various organizations (www.nelac-institute.org; www.epa.gov; www.iso.org).

Within academia, the set rules of the regulated community do not always apply. In many cases, even the simple batching methodology used within regulatory compliance does not smoothly fit. While anyone with laboratory experience will vouch for need of proper quality control, how and how often may vary greatly depending on the research being performed.

The use of COTS (configurable, off the shelf) LIMS by academia is often made possible through the ability to turn on/off various QA/QC criteria, as well as adjust holding time acceptability, minimum/maximum temperature allowances, etc. The configurability in a particular COTS LIMS can be key.

Upon occasion, the typical QA/QC processes used in regulatory laboratories may be overkill for a certain project. In other cases, especially if there exist potential for matrix interference, the quality control may go extremely in the other direction with virtually every sample matrix spiked. It is definitely not a case of one size fits all. The end user must have the flexibility required to adjust QA/QC to the appropriate levels for a given project even if it varies between multiple projects.

For any additional information or questions regarding the article, please contact Robert Benz (rbenz@khemia.com) at Khemia Software, Inc. (www.khemia.com).

Interfacing LIMS to Other Commercially Available Software Packages

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By Robert Benz, Sales & Marketing Director, Khemia Software Inc.

A LIMS by its name is a laboratory information management system. LIMS over the years have increased in their breadth of coverage, however, at no point is a LIMS a full accounting package or geographic information system (GIS) nor does a true LIMS replace a customized enterprise resource planning (ERP) system. A LIMS though may be very effectively interfaced with other software platforms to provide a business entity the full breadth of information and ability it requires.

We often get asked, particularly from clients who run an internal support laboratory, about additional functionality that goes far outside of the LIMS. As opposed to expanding and customizing the LIMS to areas outside of the laboratory, we discuss the ability to adjoin the LIMS with existing applications already on hand. We often explain that while we may not be the best at accounting, their existing accounting software already in place is ideal; we instead demonstrate how to push the needed data into their accounting package as needed. In internal laboratories in a production environment, often conversations on how their fully customized SAP system (http://go.sap.com/) need not be messed with come into play, but how to simply push the needed data to the LIMS and how to extract the needed data out takes center stage.

Similar examples can be seen within engineering companies that have a laboratory attached. As opposed to recreating a wheel, we commonly work with outside software packages for the field data and graphical reporting like SampleServe.com (www.SampleServe.com) from which we pull/push data to/from as it flows through the laboratory. This approach best allows each platform to do what is designed to do best.

In the end, a good LIMS is written by programmers and chemists/biologists who understand specific laboratory environments, similar to the way programmers and accountants work on accounting software, programmers and geographers work on GIS, etc. There is no substitute to having professionals within the industry write a specific software platform in conjunction with good programmers for that industry. With that in mind, there is no better way of handling operations than adjoining the programs to let each take care of what it does best.

For more information contact:
Robert Benz, rbenz@khemia.com, 843-810-2075
www.khemia.com

You may also see this article in this weeks LIMSfinder.com newsletter:
http://www.limsfinder.com/BlogDetail.aspx?id=41973_0_2_0_C

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Benefits of a LIMS implementer’s firsthand laboratory knowledge

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By Robert Benz, Sales & Marketing Director, Khemia Software Inc.

No LIMS, no matter how great it may be, is one hundred percent beneficial without proper implementation and training. Modern day LIMS are too complex with too many functions to truly just figure out on your own. However, many times, a LIMS implementation has failed simply because the implementer understood the computer system but fail to comprehend the laboratory itself or vice versa.

For LIMS companies, one of the hardest positions to fill is that of a good implementer. It is no easy task. For starters, a good implementer must have a full understanding of the LIMS and its functionality. The trick is in finding a person who has done this for a while, yet at the same time, fully understanding the laboratory’s needs. To pretend a programmer knows chemistry methodology would be the same as pretending that a chemist is the best programmer; very rarely the case. And, to truly understand a laboratory from start to finish, one must spend some number of years working within laboratory environment. There is no substitute and no book that you can read to replace firsthand laboratory experience. I myself spent years in the laboratory and can vouch for this. The laboratory staff always quickly learns if the implementer has had true laboratory experience or not.

Implementation and training are the key steps to successfully using the right LIMS once selected. Having an implementer who has sincerely been in your shoes with a new LIMS, who understands the analytical methods you are running, who understands the quality control and validation methods you are using and who has been through the audits which you will be undergoing is something you cannot replace. At Khemia Software, we have been especially lucky. Our lead implementer of over nine years now had over 14 years’ experience in the laboratory ranging from a bench chemist to running GCMS to QA/QC to being in charge of audits and accreditations. As is the case in many areas of life, there truly is no better background than true experience.

For more information contact:
Robert Benz, rbenz@khemia.com, 843-810-2075
www.khemia.com

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