Legislation in any well-functioning industry evolves over time. Life sciences and clinical research are no exception. Becoming aware of those changes in good time to meet regulatory compliance is your first issue. However, regulatory bodies such as the Human Tissue Authority (HTA) issue advanced notifications about proposed changes to the licensees. So, you should have a “heads up”. Now, you’ll have to consider whether the change is relevant to you. Plus, you’ll need to consider whether you need to change your Standard Operating Procedures (SOPs) to comply. If your Laboratory Information Management System (LIMS) is supporting regulatory compliance you’ll also need to think about what changes you’ll need to make to the software.
Do you need to change anything to maintain compliance?
You’ll need to review the legislative changes and decide whether they affect your lab operations. It might be that a clarification has been issued about processing donated tissues from a deceased donor. If your lab never processes tissues from the deceased then there will be no impact on you.
However, even if a change doesn’t apply you still need to give it due consideration. And it’s worthwhile formally documenting the consideration, even if it results in no SOP changes. You can then present that documentation on your next audit. This will show the auditors that you’re operating due diligence in this area. It may win you some “brownie points”!
Where do you record such information so that it’s easily producible for your auditors? Well, if your LIMS allows you to store activities or process documentation then that’s the obvious place. If not then hopefully you have some kind of document management system to record the new versions (and archive the old versions, too).
Don’t forget that if you’re also operating to ISO 9001 or equivalent standard then you’ll need to update your Master Document Register. Also, don’t forget to record when the review meetings took place and who was involved. If you’ve gone to the effort to follow best practice then you want audit trails to provide good evidence of that!
Rolling out new SOPs to your team
If the updates are relevant to your laboratory operations then you need to decide what changes you need to make to your daily work to accommodate them. This may be just clarifying the wording of relevant SOPs or introducing new steps. Alternatively, it may just be changing the data that’s recorded afterwards.
Whatever the changes are you must ensure you communicate them clearly to your team. It’s also a good idea to record the fact that you have done so.
You may also need to revise your SOP documentation and make them available to all staff. This could ideally be via your LIMS, which is where they record the results of their lab processes. It’s obviously best to keep the results of your processes and the processes themselves recorded in the same system, if you can.
Remember to keep the old versions as well. This is so that you can show auditors which SOPs were current at the time of historic processing. They’ll then be able to check that your team was following correct practice at any point in the past.
You may need to hold some refresher training to relevant lab staff, and you should record both the updated SOPs and the training records in your LIMS if that facility is available. Your staff training records help to show competence but also supports compliances such as HTA, GxP, MHRA, ISO 15189, etc.
Do you need to change your LIMS for regulatory compliance?
Now, if an SOP changes, consider any processing in your software that may be in place to support it. This could include changes to your sample management workflows, data entry screens or quality control measures. If the SOP has changed are you able to easily change your system to match?
If your system is built in-house e.g. using Excel or Access you need to find out who can make the changes and, importantly, test them. You’ll need to fully document the changes made in your system as well prove that the new system processes have been correctly validated.
If you are using a commercial LIMS it should be easier as much of the work is lifted from your shoulders. However, you still need to make sure that the changes are easy to make, either by you or by your supplier on your behalf. Again, budget not just for the costs of making the changes but also the time for your team to test them thoroughly.
Even a small legislative change can have significant knock-on risks and costs. You need to thoroughly consider the changes and manage them carefully.
It’s important for you to show that you’re are working to current best practice and working legally. This means your lab or Biobank having regulatory compliance. Plus, you want to demonstrate that your process review/change protocols are effective and you’re managing changes to SOPs effectively. This may also include updating any lab or Biobank software supporting regulatory compliance. Effectively managing and evidencing these changes goes down very well with auditors and increases your lab’s reputation within your institute and, in turn, the institute’s reputation externally.
Changes in legislation are an opportunity for you to show the world just how professional you are and why they should be using your services!