When it comes to configurable Laboratory Information Management System (LIMS), Biobank Information Management System (BIMS) and Sample Tracking Software – “It Ain’t What You Do, It’s The Way That You Do It”… And as the old song continues, “…that’s what gets results”.
Well, with Laboratory Information Management Systems (LIMS) and Biobanking software we know that everything is about results. If you’re in the market for a new system, then you need to be confident that any promised benefits will actually materialise.
A configurable Biobanking system or LIMS can help you get the most from your investment by increasing the software’s longevity. As a result, the software continues to meet your requirements in the future. And if you can do this without investing in months of training or specialist developers this will keep costs down.
But let’s face facts. Absolutely every LIMS or BIMS supplier says their system is “ultimately flexible” and “configurable to your exact needs”. So, how do you start to differentiate between all those wonderful claims? And what exactly does ‘configurable LIMS’ mean?
Firstly, you need to understand the different configuration tools suppliers use in their systems. This allows you to validate those claims and understand which best meet your needs. You can also look at their techniques and technologies. This will then help you decide whether you think the claims are valid or whether it’s just marketing hype.
What are configurable screens and fields?
It’s almost impossible to find a LIMS or Sample Tracking system being sold that doesn’t allow you to add your own fields to screens. But are all of them actually providing you with the same capability?
Several systems still employ the technique of building some pre-configured general-purpose fields into their data tables. This includes fields named something like USERSTRING1 or USERNUM2. You can then relabel these on screen to look right.
But are there any drawbacks of this low-tech approach? Well, yes, there are some big problems.
Firstly, when exporting or analysing your data you’ll always need to remember that USERSTRING1 actually holds, say, your Tissue Type. You’ll have to remember all of the field names all the time. Also, it becomes very difficult to ask others to analyse your data for you.
Next, using renamed general-purpose fields limits the number you can use. Once you’ve got past USERSTRING10 and you find there aren’t any more, you’re stuck! You find yourself “making do” by repurposing fields. As a result, you’ll end up losing historic data or blurring business rules.
The very best way to provide this is to allow users to add all new fields with whatever name and data type you want. However, you also should be adding these fields right into the core data table – not into an “extension table”, which has its own set of problems!
Can you really make the changes yourself?
When calculating return on investment the total cost of ownership is a key consideration. Being able to make your own changes to the LIMS software impacts this calculation. When it comes to being able to make configuration changes to your lab information management system or Biobanking LIMS, understanding how much you can do yourselves is important.
If there are limitations, then it’s critical that you understand what these are. You may be able to change fields, for example, but not able to change laboratory processes or workflows.
You should also try and get an indication of what skills or training you’re going to need to make any changes. Plus, identify if there are any additional licenses or support services that you need to put in place – these could be seen as an advantage depending on what they cover.
Even if you’re not planning on making any changes yourself all this can give you an idea of how much time it will take for any configuration changes you need to be made. You may think it’s too time consuming for you to carry out changes. However, armed with this information you’ll have a rough indication of how much it’s going to cost for the supplier to make the changes for you.
Finally, make sure that any changes you do make are not going to disappear when the supplier upgrades the software.
What about configurable encryption in LIMS or Biobanking software?
Data security is important. Several (but not all) LIMS and Biobank systems support encryption. Some may say “the entire database is encrypted. What could be safer?”.
Well, if you encrypt the entire database then that means access to the encrypted data is granted as a whole. You either see it all or you don’t see anything. It’s certainly good if your database is hacked but it’s not providing data to staff within your organisation on a “need to know” basis.
The best solution is one that allows individual records to be decrypted based on business rules that consider the current user, record type and task. You should also be able to change those business rules, too, and decide which individual fields are encrypted.
Adding to or changing what you’re auditing
Another key feature of a LIMS or Biobanking software is an audit trail. This can support you in meeting regulatory compliance requirements as well as provide chain of custody information. So, what about configurable auditing in LIMS or BIMS – where you can decide what you want to audit?
If you’re subject to HTA or MHRA legislative oversight or just want to maximise your data quality, you’ll want appropriate changes to be automatically audited in your database. But “Automatic Auditing” is another of those boxes that LIMS and BIMS suppliers always tick in the literature.
Again, there are very different ways to do it with big implications. Some systems provide “full auditing” by taking a snapshot of an entire record every time you make a change to any field. That works and you can view a record as it appeared at a particular time in the past.
However, it’s massively inefficient and isn’t scalable. If a record has 200 fields and you change one of them then you save 199 of them unnecessarily! The overhead will be massive.
At the other end of the scale is simple record-level auditing. This is efficient and scalable but limited as it only tells you when a record was changed and by whom. Not which fields you changed and not what the values were before or after.
The best option is for you to be able to decide which fields you need to audit in order to record the before and after values, when it was changed and by whom for only that field. If you want to audit every field, say for MHRA compliance, then you can switch them all on, but you only need to record changed fields. As a result, you get the perfect balance between performance and compliance.
Managing your data validation rules
A successful system must work with accurate data. We all know the adage “Rubbish in = rubbish out”. So, your system should support you in enforcing good data quality.
Plus. you should be able to enhance this where needed.
Again, all systems purport to provide this. However, usually it’s just by selecting appropriate field data types to ensure that only numbers are accepted in numeric fields. That’s good as far as it goes but you also need to have text fields restricted to picklists of valid values.
You must be able to maintain those picklists yourself and you should have the ability to specify those on a per-team basis. Also, check whether you can apply business rules based on values in other fields and whether you can change the rules.
How do the data transfer tools manage fields and tables you add?
Your system is a tool to help you do your job and you can best do that when you’re not having to manually enter data when you have it in some electronic format already. Exchanging data with other systems can be a very efficient way to speed processes and minimise manual data entry errors. Therefore, good import and export tools can be very important.
Make sure, though, that your import and export tools can fully support those new fields that you’ve added. Your own custom fields shouldn’t be “second class citizens” and you shouldn’t have to work with fields such as CUSTOMSTRING1!
Similarly, when you are searching for records in your LIMS or BIMS you need to make sure that any fields you have added or amended are automatically available for you to use.
Understanding the configuration skills of your LIMS or BIMS supplier
Ultimately your supplier is supporting your system and you need to know that they have your best interests at heart. If they are a reseller then chances are, they supply other systems as well so their skills will be spread. If you deal with the software developer themselves then their product support team will most likely be more knowledgeable.
Having contact with the people who decide how the product develops can be really useful! Also, if something goes wrong, who do you want on the phone – the actual developer or a reseller with little or no ability to actually fix a bug?
Final thoughts about configurable lab information management systems
Although every LIMS or Biobanking software supplier has ticks in all the boxes that matter to you, it’s possible with a bit of digging to verify whether they really do “walk the walk” when it comes to configuration. Talk to existing customers. Ask a few questions about how they do the things they advertise.
As a result, you’ll be able to decide whether each claim is backed by evidence or just marketing hype. This all helps you understand just how configurable Biobanking software or LIMS actually is. And, importantly, what it’s actually going to cost you.