How do you validate a LIMS system

Hi All,

As the chief validation analyst in our company, have been asked to put together a plan for how to validate our new LIMS system. I have many years of validation experience but I have never validated a LIMS system before.

Could someone point me in the correct direction as to how to begin this process.

I have read that validating a LIMS system is all about breaking it down into different modules.

Any input at all would be fantastic


Wow! I assume you are looking for an abridged version…I will assume that you are following some SDLC and you will have validation plan .

One thing you can do is to group equipment into families and then validate one piece of equipment in the family. Then making a flying leap that all equipment in the family is validated for the LIMS. Well not really a flying leap, the equipment should be the same (notice I didn’t say identical); the flying leap is the logical persuasion you use to define same. You can also write a procedure on how to add another, say HPLC, to the LIMS. That way you can release the LIMS into production before everything is validated. It can kill a project to require every piece of equipment to be validated on a LIMS before going live. That means you have to write into your validation plan how you intend to control this go live period.

You are correct that LIMS can be modular in design. Hopefully, you have somebody who understands the software and the underlying data requirements. You can also specify in your plan to validate data collection first with release criteria, then training or calibration. One thing I have learned, define what you intend to do in your plan and then follow your plan. The FDA loves it when you don’t follow your plan and provide no explanation for not following.

I got pulled away in the middle of this…

Hi Meyert,

Thanks for your response, yes we have got a system lifecycle, and we are starting our validation plan next week.

We have that HPLC scenario you are talking about, very interesting!

We have 8 in total which are identical, are you saying that we validate one completely
and as long as we can prove that they are like for like, then we can do reduced testing on the rest.

Perphaps even a connection verfication test would suffice in the IQ.

I would love to hear more of your thoughts on this.

Thanks alot