New System Implementation

[Cliff]

Hi,

We are in the process of installing Mediware’s HCLL and LifeTrak Lab / Donor.

I know there are not many implementations of HCLL at this point.

I am looking for information on how people have approached the process of system validation.

We will be relying on the vendor quite a bit to provide validation scripts to us. We also have in our contract to have Mediware assist us with the overall validation process. At this point Mediware has not authorized any third party validators to work with HCLL.

We have a very complicated conversion process. We are currently operating as two separate donor centers that have separate deferral systems yet share donors, so data conversion will be a challenge.

Has anyone undertaken such a large project? If so, it would be great to hear from you.

[korchek]

We have performed validation and data conversions on many different systems. We are currently talking to Hemocare about being a certified validator. Send me email if you would like to discuss further.

[David Saikin]

It hasa been my experience that most folks go overboard with validation. Some feel that you must validate everything a system does, or can possibly do. I feel that you only have to validate the aspects of a system that you are going to utiliize. I look at what my facility does and how my system is going to perform those things. So far, I have validated 3 systems, including a donor module, with no problems from the FDA regarding my implementation.

[korchek]

I agree that you can go overboard. How often are people cited for validation? The primary goal is for you to be confident in the system. Why would you validate functionality you are not using. Best thing is to keep it simple.