Let’s start by making it clear that there are many things an electronic management system can do to improve your laboratory: a good system, properly configured, can deliver lots of efficiency gains, data integrity improvements, record controls and data sharing through the organization. It also becomes a source of data for company-wide analytics and monitoring.
Once you implement a system, you will wonder why you took so long to adopt one. But sometimes, companies that are in desperate need of electronic data management mistakenly see LIMS/ELN as the solution to all their data woes. We all need an occasional reminder that buying a software solution is not the same as solving a business problem.
So what will a LIMS/ELN system not do for you? I’ll give you three to consider:
- LIMS/ELN will not fix your ineffective business processes. I would even go so far to say that you will not many of the benefits of LIMS/ELN without looking carefully at your existing business practices, then changing them as needed to align more effectively with your electronic system. For example, interfacing the LIMS/ELN to standalone instruments not only reduces transcription error, but also adds metadata about the collected testing data (who collected, date/time, instrument ID, etc) and accomplishes the work more quickly as well. The ability to electronically link back to the source data also has the potential to improve second person verification prior to test result release. Again, these are all possible after the business process has been modified to use the new system strategically within the business processes. To modify your current process, it is necessary to formulate a list of business requirements, create a flowchart of the current process and have a current systems inventory. These tools enable a cross-functional team to draft a new, efficient process that will increase the return on your systems investment. Don’t neglect the fact that a new process might also change your configuration of the new system. For example, your team might determine that a test result needs five statuses for its life cycle (created, logged, in process, complete, released) plus other statuses for alternate situations (withdrawn, suspended). These will need to be configured in the electronic system, possibly along with associated business rules. So the process may be influenced by the technology, and the technology influenced by the business process.
- LIMS/ELN will not address many of your data integrity issues. Yes, it can address some of your integrity issues. If capable and properly configured, a LIMS/ELN can record every change to critical steps in the data lifecycle. The electronic system also provides lots of timestamps that cannot be altered by users, providing a wealth of metadata that can be used to confirm the validity of reported data or conduct detailed forensic investigations to answer what happened, when did it happen, and who did it. This wealth of non-modifiable metadata is one of the greatest benefits of LIMS/ELN and enables many of the future reports your organization will create to create metrics for data integrity and laboratory performance. But on the dark side, there are still many ways for determined individuals to improperly manipulate data, even with the best LIMS/ELN installations: users can perform testing on a standalone instrument multiple times, pick their favorite run and send it to the LIMS/ELN and delete the additional runs on the standalone system—LIMS/ELN will have no record of this behavior. Test data can be stored on local computer controllers with no backup. Manually-entered data can be changed at will before entry and without a witness, nobody will detect the inaccuracy. Electronically-collected data can still be manually changed—yes, a record of the change is recorded, but without robust second person verification the improper changes will go unchallenged in too many laboratories. If access controls are not properly designed or managed, it will be possible for users to move test results into “parked” statuses (e.g. Suspended), or even removed from the system altogether. Many of these improper actions are possible even in well-implemented systems; therefore, the organization must detect these behaviors through queries that can be managed as part of the company’s cultural excellence programs.
- LIMS/ELN will not improve your data quality. The electronic system will do a marvelous job of collecting poorly defined data. To be able to have powerful searches that can compare data across multiple business sites, stages of product lifecycle or data lifecycle, the business must have corporate-level data standards to name all attributes that will be collected and managed. These standards must be embedded into the practices of the new LIMS/ELN, or the business receives little benefit for the move from paper to electronic data. Permitting each business unit to have their own naming convention is a death sentence for forward-looking data analytics. A LIMS/ELN, used with data standards, can yield a treasure trove of business insights—I have seen it, and it is a beautiful thing. The ability to compare multiple labs across the globe, and ask, “why does lab X have a 5 percent difference from everyone else using potency Method XYZ?” can be a game-changing insight in your Quality journey. But you will not get there without standardized data—and your new LIMS/ELN will not standardize it. This is where experienced people craft a standard, supported by senior management and enforced throughout the organization.
As I said earlier, the decision to implement a LIMS/ELN system provides numerous benefits and can even create competitive advantages for an organization, but along with the investment comes the necessity to make business changes that will maximize the return on investment. These added steps will provide long-term rewards many times their initial investment.
Originally published by Mark Newton (Principal) on 11 July 2018