Along the way, in trying to sell my services, I hear a variety of stories about systems and their problems. Recently, I’ve been hearing stories of non-compliance. I hope this is a coincidence rather than a trend.
Too Few LIMS Resources
One group I spoke with purchased a LIMS system that was just too big for them to handle. As a result, they’re stretched beyond the ability to manage it. They don’t have a LIMS system administrator, staff gets so stressed-out and overworked that they leave for other jobs, and they have a list of compliance tasks that they think they should do but just don’t have the time for.
As I always like to remind people – I’m not a compliance person. As such, any opinion I give on the matter is suspect. With that said, somehow, I doubt that telling regulatory auditors that you didn’t have time to handle your compliance activities is considered to be a valid excuse.
And, let’s suppose that an audit merely gives them an ultimatum by giving them some amount of time to take care of the issues rather than a fine or being shut-down and they don’t have the people to do that work, don’t have the know-how to attack it. In speaking with them, even if they could come up with the money to do this work, I don’t think they are at a point where they could work with someone to resolve the issues in a timely manner. For example, in asking them several times about what their plans were to get or create a LIMS system administrator, they just couldn’t seem to attach to the idea.
LIMS Gets Off-Track
Over the years, I’ve run into several LIMS implementations that have started in what was thought to be a compliant manner but that went off-track and became non-compliant in some way or another. In speaking with this particular group, their LIMS implementation was appropriate in size for what they needed, the features were appropriate, they finished their validation activities in what they thought was a reasonable amount of time, and they thought they were all set. But they were wrong.
Somehow, they let themselves stray from their SOPs (Standard Operating Procedures) and their system became non-compliant. Sadly, just like all the other systems I’d run into that let this happen, they never made the effort to address the issues. The problem with addressing the issues, people think, is that it shines a light on the problems. It’s as if it’s inviting an audit. That might or might not be true. But in their case, as in some others I’d known of, the results were dire. When the eventual audit came along, that system no longer now exists nor do those people still work in that group at that company.
LIMS Compliance Lessons
Hope doesn’t make a system compliant nor do excuses. We all know that there’s no more pressing issue for labs then getting the samples in and out and it can be difficult to make time for other issues such as figuring out what to do with compliance problems. In the end, though, without proper compliance you might have no lab at all to worry about. Take time for compliance. Don’t let “We don’t have time” or “We don’t know what to do” be the excuse that stops you from handling these things.
Note: While these stories are about LIMS systems, keep in-mind that I work more with LIMS than other products so I hear more LIMS stories. It doesn’t mean that LIMS implementations are worse than the other types of systems implemented.
3 Thoughts to “Matters of Non-Compliance”
Gloria, loved your post today. Very appropriate to all industries. Data integrity is making systems that used to be compliant non-compliant due to the controls and auditing that regulatory agencies are expecting as of lately.
Please also consider that when a LIMS is used in other areas like pre-clinical, clinical and post-market surveillance other regulations need to be added to the mixture, such as HIPPA, SOX, DEA, etc.
By the way, when you mentioned that this is appropriate to “all industries” it brings up the point that it’s not just regulated industries that have to manage their systems. Even though the examples I gave are specific to regulated industries, even non-regulated systems need a LIMS (or ELN, LES or SDMS) System Admin, plus proper care and maintenance. It’s a terrible thing when any of these systems are left to “rot” because companies spend so much money on them, to begin with, that a few proper maintenance and usage practices really make a difference between the system becoming an investment or a waste of that money.
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