What is blood bank and donor system validation?Validation of blood bank and donor systems means establishing (by objective evidence) that all the software functionality has been met, implemented as specified, and is traceable to system requirements. This includes meeting the requirements of the U.S. Food and Drug Administration (FDA) and the American Association of Blood Banks (AABB).
Why perform software validation?- Required by the U.S. Food and Drug Administration and AABB
- Reduces risk to patients
- Reduces legal liability of your institution
- Minimizes reportable incidents and corrective actions
- Decreases failure rates
Why use an outside firm for blood bank validation?- Lack of staff available to spend the required 300 to 500 man-hours of work to complete validation
- Staff is inexperienced or untrained in software validation
- Independence of review
Why R.F. Nozick and Associates?- Specialists in blood banking and information technology
- Experts at validation documentation development including: cases, scripts, SOP’s, and plans
- Current in all U.S. FDA, AABB, and ISBT requirements
- Member of AABB information technology committee
- 18 years performing validation services for 475 hospital blood banks and donor centers
- Experience with all major blood bank systems including: Cerner, Mediware, Sunquest, Soft (SCC), and Wyndgate
Why should we support third party validations?Join the discussion or read others' opinions in the California Blood Bank Society forum.
Is it possible to completely test systems?The short answer is no. Your best bet is to assess risks and concentrate on validating those issues. R.F. Nozick follows this principle to ensure maximum safety and reliability for our clients. Check out Cem Kaner's article "The Impossibility of Complete Testing" for more discussion on how much testing is enough and why you can not test exhaustively.
|
