Hello everyone,

The FDA has put out Guidance for Industry: Blood Establishment Computer System Validation in the User's Facility.http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Blood/ucm072560.htm?source=govdelivery

D. Scope of Validation

“Your activities should assure that the system components have been validated and are suitable for your specific operations and workload and can accurately and repeatedly meet your needs (as defined in your requirements documents). You should validate your system at your location using the same software, hardware, SOPs, and personnel who will use the system after it is formally implemented. Thus, in cases where a central server is used by multiple locations, not only the main server but also each individual location should have a validation plan that is specific to the functions and configurations at each location. Equipment vendors may provide assistance for equipment qualification and consultants may provide assistance with the validation project. However, you are ultimately responsible for validation of your system in your facility.

Validation of your BECS falls under your Current Good Manufacturing Practice (cGMP) requirements and should reflect and anticipate the BECS’ actual use in your establishment. We recognize that it is a common practice for software manufacturers to provide test cases to blood establishments for use in system validation. We recommend that you carefully assess the software manufacturer’s test cases, consider your own intended use of the software, your internal policies and procedures, and add or change test plans as appropriate to ensure that the software will accurately and repeatedly meet your requirements. The test cases should include those that represent “worst case scenarios,” e.g., maximum numbers of users working simultaneously, all possible activities occurring simultaneously, etc.

We recognize that BECS validation is difficult because you cannot test indefinitely, and it is hard to determine how much evidence is sufficient. Generally, software validation is a matter of developing a “level of confidence” (Ref. 1) that the software device meets all requirements and user expectations for the automated functions and features of the software.”

FDA, April 2013

We have in the past used an outside company to provide validation services for us. With limited staffing we don’t have the time or expertise to complete this testing at least not on our initial conversion. We are due to upgrade soon and wondering; everyone’s take on this new Guidance. Our Validation Company does not come on site; I know that they will be an additional cost if they do. Any comments or suggestion would be helpful. Should we us any outside company or not?

I have never used a validation company or the the vendor's scenarios. As with any validation I define the function I am testing, how I am going to do it, what the expected results are, what the results really are (if they differ from anticpated - how I eventually got to the anticipated results), attach documentation and save ad eternam. I have validated Hemocare (twice) and a few versions of Cerner, including Donor modules.

Granted it is time consuming but I have found that by doing my own validation I discover any quirks and/or multiple means of obtaining the same end. It is good for the staff also as it provides hands on experience aside from the training that is incumbent with the new system.

I know larger places have farmed out their validation due to the concerns you have - expensive and, while accepted in the regulatory environment, I think doing it yourself provides a much better perspective.

Just a thought. SHOULD does not equal SHALL. I know that's been a bone of contention for many years but the word should does give you some latitude. :raincloud :raincloud

I have done both- used an outside company and performed it myself. For our implementation of Sunquest several years ago, we hired an outside company to perform all the vendor scripts- basically making sure the system did everything Sunquest said it would. I then performed a validation of every procedure the way I wrote it for the computer system to make sure it would work as we expected it to. Future upgrade validations were not usually so time consuming so I did those myself.

I agree with David- if you do it yourself, it will help you understand how it works better and will let you know that it all works as it should.

I agree with David too, validation helps you learn the system inside and out.  

 

I've never worked anywhere that farmed it out, too expensive.  Of course I like to do this kind of stuff, I know I'm crazy, can't help it.