I work for a small clinical lab (aprox 20 lab techs) who has previously been subjected to CLIA rather than FDA regulations. As such, we have not validated our LIMS (Lab info management system) which tracks and creates our patient reports. My company recently decided to start accepting samples for pharmaceutical companies for clinical trial purposes, so I am implementing GCP for the lab. Obviously, we need to get our old (but still in use) LIMS validated, as well as the new one which is currently being debugged, and not yet iimplemented. The new system does have electronic signatures and is suposidly complient. I was not here when the decision was made to purchase the software.

My background is in QA and Regulatory Affairs not IT, and I'm not sure how to go about getting this validation accomplished. Is this something we can hire a consultant to do for us, or is it something the IT manager who is implementing the LIMS should be doing?

Thanks is advance, this area of software validtion is new to me and to my company and I really appreciate any guidence any of you have.

oh, one other thing I forgot,

The IT manager is wanting to do very minimal duplication between systems when rolling out the new software. He wants to roll out the software prior to validation, and with only a few weeks of duplication. I am against this, but need to know what other groups do prior to the roll out so I can give the management team a better reason for why an extended test period is a necessity.

You can absolutely contract validation out otherwise I'd be looking for gainful employment. ;-)

Start with a validation master plan. Decide what all needs to be validated and any general approaches you plan to take to validation. In parallel, develop requirements specification(s) for the software. You have to know what it's expected to do, what regulatory constraints there are (HIPAA?, part 11), security (both usage access & data control), etc. Ensure the software is locally under proper configuration control, ensure your software vendor adequately manages the software, develop the test protocols based on the requirements, run them, record the results, and viola! you're done.

Indeed, this is why many companies contract this stuff out. Having expert support really does save time and money in the long run, IMO (but maybe I'm biased).

My friend , yodon is right and I would also approach in a similar way. Most organizations contract this activity outside as this involves lot of expertise which our regular IT folks may not be having. Besides, the Computer System Validation (CSV) is a very dynamic area and the experts in this domain are abreast of all changes.

So, my suggestion would be hire a consultant or get in touch with the LIMS software supplier to provide guidance on validation :)

Good day Erikam

This process can be carried out by yourselves or an outside contractor. I would suggest that you start the process yourselves and define your basic requirements, by raising a User Requirements Specification (URS) and in it document what your end users want the LIMS system to do.

Follow this by executing a Risk Assessment against these requirements to define the seriousness of any default condition.

This will enable you to document a justification for the depth and scope of the validation you undertake. Once these two tasks are in progress, you should raise your Validation Plan (VP). In which you can detail all responsibilities, methods and requirements, that are essential to the compliant qualification of these LIMS systems.

At this stage you will be able to judge what can be done with in-house resources, and what requires external assistance. You will also be able to scope the subcontract work.

We have a free SOP on Equipment Validation, if you can post your email address I will send you a copy.

Alex Kennedy
validation-online

Thank you all for your advice. I think we are going to contract this out. The IT Manager "has all this information in his head" and extracting that information would be easier for a knowledgeable outsider.

Our consultant is going to develop an IT validation policy, create a validation plan for the old and new Lab info systems, develop change control documentation, and assist in conducting a retrospective vendor audit.

Thanks again, you gave me a great starting point in figuring out what to do!