Automated Level IV Data Packages for Environmental Data Reporting
Adopting modern LIMS systems that can provide insurance for environmental laboratories
Khemia Software
Nobody likes to pay for certain types of insurance until they need it – especially home, auto, life etc.
But in the environmental sector, there is a type of insurance that is often utilized and is valuable even if the results aren’t being legally or scientifically challenged.
Level IV data packages provide the most complete picture of data, quality control, calibration and total traceability, helping environmental labs to remain current while serving high-end clients with legally defensible and scientifically valid data. These Level IV reporting capabilities allow automated data to be generated easily from a fully implemented modern environmental LIMS.
A Level IV package contains all raw data, such as instrument chromatograms and other instrument printouts, along with the data results. This type of reporting includes specific data that is required to fully reconstruct the laboratory results, with much of the information available through PDF reports. All information can be dated, time stamped and available for independent, third-party data validation.
A Level IV Data Package includes everything needed to trace the production of analytical results including field sampling and shipping chronology. All notes, printouts, sample results, dated materials, analysis and validation, communications and more are tracked and generated from the data elements stored in the LIMS. Every element needed to defend the validity of data is there, if it happens to be challenged years later.
The impact of Level IV
If you want to succeed and stand apart in your industry you will want your environmental laboratory to provide Level IV reporting. After Level I (analytical results) and Level II (QC data that confirms the level of required precision and accuracy, a Level III package goes a step further to include instrument calibrations. A full Level IV data package includes all level I, II, and III information plus raw data, reagents & chemicals used, prep logs, internal chain-of-custody etc.
For most LIMS providers, the reporting capability is limited to Level II because their product is designed for labs in general, but for commercial environmental labs, which routinely provide analytical services for projects funded by Federal & State governments, level IV functionality is essential to stay competitive and comes in handy when a client requires it. A sophisticated and easy-to-use “CLP-Like” level IV data package that is validation-friendly can provide all analytical data reporting requirements, including raw data and CLP Forms.
Scientifically valid and legally defensible
Level IV reporting has only been available through a minority of LIMS providers in the past few years. But it basically provides an insurance policy to your lab and a competitive differentiation that will benefit your clients.
Jerry Singh is the president of Khemia Software, provider of the Omega 11 LIMS production. He can be reached at jsingh@khemia.com. Visit http://www.khemia.com/ for more information.
