Just yesterday, I ended up in a conversation about product safety. Today, I’m writing about how LIMS product safety tracking is part of that.
What We Do
Occsaionally, people outside our industry ask me what I do for a living. I tell them that I work with product testing software, both for research and for quality control.. While that definition covers most of what we do, it does require being loose with the definition of a “product.”
Five Basic Elements of What We Do
Here is what I see as five basic elements of what it is that we’re trying to accomplish with the software we use,. This includes LIMS, ELN, LES, LIS and all the other acronyms:
- Collect information to track research.
- Gather data that might be needed for patent applications or to show to investors.
- Aid in ensuring product safety.
- Ensure quality control beyond merely product safety, to create consistent products.
- Help meet regulations.
Notice that I said they can “help” with meeting regulations. Software only helps you meet regulations. You as a company meet or don’t meet regulations. A classic example is that too many companies look for 21 CFR Part 11 – compliant systems. A system is not 21 CFR Part 11 compliant – it is only capable of being so. Your implementation and use of it is what makes it compliant or non-complaint. Stop asking vendors for “compliant” systems, please, and start asking how their systems help you to meet the compliance you need. It’s similar with LIMS product safety – the system doesn’t ensure safety – it just helps YOU ensure safety.
Comments on Product Safety, In General
While many companies are serious about product safety and consistency, others aren’t. In addition, some of the companies who are serious about safety, don’t necessarily understand what it takes to make products safe and consistent. They might not be able to consider LIMS and product safety.
For example, I recently read an article about the explosion dangers of canning fermented products without the proper pH. When we brew things at home, there is the occasional danger of exploding bottles. This depends what we’re doing and how well we control our process. And, keep in-mind that some commercially brewed products began as someone’s hobby. That is why some people no longer use glass bottles when home brewing. It’s because they don’t want to risk the glass shards. In addition, they don’t necessarily plan to do the testing that helps avoid that.
Then, making a product commercial requires an understanding of what it takes to package it and make it in a safe manner. In our systems, we test for specific parameters to check for safety, basically. But without understanding the science behind products, it can be a tough hurdle to figure out how to ensure that the products are safe.
Think of this another way – people come up with all sorts of great ideas for products. They make them with the best of intentions and work hard to sell them. It does happen that there are occasionally uses or issues that they didn’t foresee. And, in some cases, these unforeseen situations are a safety hazard.
How LIMS or Other Software Can Help With Safety
Once, again, product safety is merely one aspect to what we’re trying to accomplish. However, to accomplish the best safety possible, our efforts go a long way toward ensuring safety.
Some projects test their raw materials that go into the products. This means that the final product is more likely to conform to whatever standards apply to it. There are some products sold in a variety of situations or various geographic areas. Some of our software implementations allow different types of specification checks against a single product batch.
Example #1: Grains
Pick a grain, any grain. We use grains in cereal, brewing, distilling, cosmetics, and many other applications.
When you harvest and sell a grain, you might or might not have a specific customer. Depending on the grade of your grain or the moisture in it from a specific harvest, or many other factors, it might be sold for various purposes.
The example, here, is that you can test for the variety of factors. These factors will allow you to sell your grain to whomever would pay the most money for it. You can have specifications set for the different applications to see what industries or customers might be able or interested in this particular harvest. That allows your sales people to start calling potential customers to see who needs and wants your grain. In addition, they can do this in order of who they think will pay the most for it. Some customers are merely left off the call list if the grain just doesn’t meet their requirements This makes the sales process shorter.
Example #2: Drugs
For drugs that are made in volume, there are sometimes facilities in several countries that might buy that drug. Other times, there are facilities that just make a whole big pile of pills to sell to a large portion of the world. It depends a bit on how specialized the manufacturing for the item is. It also depends on how cost-effective it is to have a plant in a particular area. It’s also important to know how it’s going to work out to meet the regulations of the places that batch will be sold to.
Different uses of grains have a wide variety of specifications that we think of more as a product “grade.” However, in the pharma and biopharma areas, don’t think of it as a “grade,” per se, but just that different countries have come up with different criteria for testing.
In any case, where we have the case that the system must check various testing for various countries, it is often possible to implement the system to show us which countries these drugs can be sent to.
Issue in Implementation
Just as a side note to the examples I just gave, let’s talk about one issue you might already have thought about. It is that you must decide early in implementation whether it is that you make something then figure out who you can sell it to. Or, possibly, it’s that you make something that must be able to be sold to just anyone on your “customer” list?
In the pharma/biopharma example, it’s not uncommon that, all countries’ specifications must be satisfied so that that drug can be sent to absolutely any customer. This is the easiest route to take and certainly not an uncommon strategy in implementation.
If you don’t determine this, early on, you might find you have to go back close to the beginning of implementation to get everything to work. That will affect reports of all types, whether they’re regulatory, certificate of analysis, statistical, or any other type. It will typically have a ripple effect through everything you need.
Does Software Help Ensure Safety?
First, you do have to know what the safety parameters are. So, if you don’t know the science to test a new product, you can’t ensure safety. If you don’t have all the situations identified, you can’t test for them. LIMS product safety isn’t a “plugin” or “module” – it’s how you use the system.
The software we work with is expensive and time-consuming to implement. There are many situations I run into where there is no software in-place. There are a number of places where people will just go type some numbers into a document or spreadsheet if they need to report to a regulatory agency, investors, or if they start to think they want to track something.
Spending a small fortune on one of our systems isn’t necessarily in their radar. They probably don’t have the money or personnel to use and maintain the system. Even if they did, they would need something more than just software training to really understand what they need to do with the system.
With that said, there are times where implementations are industry-specific in order to help customers truly understand the issues they are trying to address with these systems. But, if they don’t understand those issues, to begin with, they might not see the value in these systems in order to bother.
More Notes on LIMS and Product Safety
So, what comes first? LIMS or product safety? I don’t know the answer to that, myself. However, for anyone reading this who is just starting with a new product in a new company, here is the link to the Consumer Product Safety Commission. They have a tool to help you at least get started with understanding the regulations behind your product.
While this isn’t going to necessarily ensure product safety, it might be a guideline that helps you get started.
For everyone else, get involved with any industry groups that are available to you. Some industries have trade groups that discuss just about anything you might need. For example, discussions on product safety, including using the safest packaging for the type of product you’re making.
I understand that some of you have concerns that employees might share too much information in these groups. Just set some guidelines for them. Put appropriate people in these groups, give the guidelines on what is appropriate or inappropriate, then check in with them on this, once in a while. However, I hear too many companies struggling to do every single thing on their own as if they’re the first company to invent the use of a packaging item. And, these are companies that aren’t in the packaging business – they’re just making something new to put in the package. So, stop reinventing the wheel.