Electronic record keeping is slowly making inroads into the analytical chemistry side of the dietary supplement business. But for many lab techs, it’s still a pencil and paper world.
Laboratory information management systems (LIMS) have been around for a while and promise some powerful benefits, including significant costs savings realized over time as errors and retests are reduced. But it’s not nearly as easy or clear-cut a decision to implement these systems as it was when personal computers replaced typewriters.
Federal regulations govern how records are taken down, manipulated and stored in a laboratory setting. This applies even to notebooks and copy paper, but they apply especially to the kinds of software that labs can use. It must all be compliant with rules designed to prevent falsification of data.
“The software that you use needs to certified with the federal code of regulations,” Frank Jaksch, CEO of California-based Chromadex , told NutraIngredients-USA. “It’s some very simplistic stuff. Is the software designed in a way to protect things so you can’t just go in and start modifying data?”
LIMS can be purchased as whole systems, bare-bones platforms with customizable features or companies can choose to write their own, said James Neal-Kababick, director of Oregon-based Flora Research Laboratories . He cautioned against the last option, however.
“A lot of times people would go in and they haven’t understood what the full implications are. I encourage people who are looking at doing any kind of electronic records to look at the detailed requirements.
"If they don’t know enough about it it’s a good idea to get a consulting expert to help them. It can be very much a money hole,” he said.
Systems must protect data integrity
The key element of the software from a compliance standpoint is that it be designed to protect the chain of custody for the data via electronic signatures and other controls. Changing values in lab notebooks would usually leave some sort of trace, Neal-Kababick said. But the concern, when the regulations were written, was that data could be altered in such a way as to be all but undetectable without the electronic controls.
Many companies operate a hodgepodge of record keeping methods, Neal-Kababick said. Companies often have electronic project management tools, but still keep their lab records on paper. Or they might have a version of a LIMS, but still output the results of their various pieces on lab equipment on paper. Contract manufacturers seem especially prone to these situations, he said, as they deal with so many different customers, many of whom might have different specific requirements for how they want their testing data recorded. These hybrid systems, composed of different parts brought on at different times, are most prone to contain one or more non-compliant parts, Neal-Kababick said.
The systems promise significant savings, especially in cutting down on human error. Using paper notebooks, if a lab tech enters a wrong value in a given box on a form, it often necessitates that the particular test from which that value arose be done over. Sophisticated LIMS can take the output from testing equipment and export it directly into the spreadsheets that form the heart of the record-keeping system.
“The biggest benefit to it is to cut down on the number of errors,” said Jaksch.
There are other savings, too. Lab systems can automatically track when equipment needs calibration and when consumables need to be replaced. And recreating how a certain test was done can be a matter of minutes, Neal-Kababick said, rather than the hours it might take to comb through and cross reference several forms of written records.
Compliance is costly; noncompliance is more so
None of this is cheap. Up front costs, including implementation, can run from $150,000 on the low end into the millions, Neal-Kababick said. Flora Research Laboratories will begin the process of integrating a LIMS this fall, he said.
However a company chooses to get it done, compliance is the key. FDA has been making rumblings about taking a harder look at software compliance, Neal-Kababick said, and getting called out by the agency on this score could be devastating.
“If there is an aspect of it that doesn’t meet Part 11, you could end up having all of your data kicked out by FDA. That’s a huge deal. A lot of people are just so overwhelmed by it that they say, we’ll just keep it all on paper. There’s nothing wrong with that.
“I think we are going to see a lot warning letters, a lot of 483s on this,” he said.