New Computer System Validation

[Kim.Turner]

We are beginning the process of validating a new computer system. Does anyone have any advice or forms that they would be willing to share about proper documentation of this validation?

Thanks!

[Cliff]

Hi Kim,

I think this is tough for anyone to answer for you.

Is this a new blood bank system, or a computer you are using for a function - such as something you might be tracking?

If you are talking about a vendor supplied blood bank system, then you might want to ask them for suggestions.

Also, there are companies that perform validations of blood bank systems, you might want to look for one of them. I know there is at least one that consistently goes to the annual aaBB meeting.

Provide some more info and I'll try to help some more.

[Kim.Turner]

Cliff,

We are building a new laboratory system for our multiple purpose laboratory. This is the first endeavor for our vendor in a laboratory site. Therefore, they are not providing any validation suppose (ie. test case studies, guidelines, etc.). It is left up to us to test the system and make sure it does everything that we need. So.... What I am in need of are any general forms/documents that could be used in multiple areas to organize/simplify testing data. Something like this may not exist.

But.... I just had to ask.

Thanks,

Kim

[luhubert]

Our computer company provided a very large notebook full of scenarios to validate all aspects of our system. Your best bet would be to ask your company for something. Otherwise - Meditech in Boston, Ma. does have a validation guide for their system that might be worth buying. It would show you everything you need to do. It's a long, time-consuming process. Ours took about a month.

[Cliff]

Hi Kim,

I want to make clear that I don't represent or support organizations or companies through this site. All are free to express their opinion.

We hired the vendor, Mediware, to provide validation assistance. We are a large facility with a difficult configuration and will spent a lot of money on this validation, I won't say how much, but it's more than I will make this year.

I know the owner / founder of this company http://www.rfnozick.com/ and I know she has material you would be interested in. They will either perform the validation, or you can purchase scripts from them. Robin is a very nice person with a lot of experience.

[ChrisH]

Kim, you said "This is the first endeavor for our vendor in a laboratory site." Then I would agree with Cliff to go with an known outside vendor to help validate your system.

I do not know if you get FDA inspected (not even sure if you are in the US). But if the FDA can come in you better have miles of paper work since you are the first group to use that system.

[John C. Staley]

If it is in the US and is for Blood Banking it had to have it's 510K approved by the FDA therefore they will know all about it. Being first should require no more effort or "paper" than being 100th. Just make sure it does what you and the vendor say it does. If you have the money available I would go with a professional validator. In the long run they will save you much more than they will cost. Like anything, besure and check references. You want the best you can afford.

[Jane]

I would definitely agree with the outside vendor. We hired a consulting service to perform our validation. My director also wanted us to do some validating of our own. I did this in conjunction with our integrated test plan. Be sure to save screen shots of everything. Misys estimated something like 80 or 120 hours for our validation and they provide a step by step guide. The most important thing is probably validating the system like you will use it.

[Blupo]

We are in the process of installing a new LIS for all our sites. It will be the first time we are all on the same page. Fortunately we are working with a company who has done many installations and are providing a tremendous amount of support in the clincal lab areas but can not in the BB and Donor room since the FDA requires independent validation separate from the vendor. We are using Validation Partners for data conversion and validation assistance. There are many publications on the subject but it still boils down to how and where do I start. In August ISBT published a supplement with Vox Sanguininis "ISBT - Guidelines for Validation and Maintaining the Validation State of Automated Systems in Blood Banking". How much validation is required is a difficult question - it depends on how critical the process your are trying to validate is.

Good luck

[Terry]

I agree with the previous post. At the AABB annual meeting in Baltimore, Robin Nozick gave a presentation to the assessors on how to inspect computer validation at a facility. Her presentation was based on the August 2004 Vox Sanguinis article on computer validation. Good examples of forms for your Validation Master Plan were presented.

[Kim.Turner]

Thanks to all for the great information. I will use it wisely. I also was at the AABB convention in Baltimore. Robin's lecture was excellent.

Kim

[korchek]

We also are a computer validation company. There are many ways to skin a cat and no one way is correct. The purpose of validation is to demonstrate confidence in the system. You are the one that must be confident with the system and whoever does the validation. Rarely do inspectors cite validation defeciencies.

If you have any questions feel free to contact me. Gregory Francis, Korchek Technologies, 877-KOR-CHEK, greg@korchek.com

[conwaysbb]

Having been involved in several validation for blood bank computer systems over the years, it has increasing become very time consuming, and personally I don't have the time or the resurces to do this in-house. I have used the services of an outside third party validation service for the last two upgrades.

I know that several of the blood bank computer companies are offering validation services, but I have a issue with the services offered. There is a serious conflict of interest here. Validation should include trying to identify if there are any faults to the functionality of the system as you are using it. You are trying to break the system. If issues come up you notify the company and they fix it or you need to include a work around. Many upgrades to the computer systems involve issues that are reported to the computer company by their clients when they validate the system. This costs the company lots of $ and time. So how much trust would I give to a validation service that is directly associated with the company? If they find an issue will they report it to you, will they sugar coat it when they inform you, will their testing even try to break the system? I personally would not have 100% trust. The FDA also recommends that if you are using an outside validation service you should use a third party validator.

I have used Korchek Technologies, but know about RFNozick and even Validation Partners and feel that they all would give you valuable validation services and have only your best interests at heart.