FDA Guidance for Industry on Validation of Blood Establishment Computer Systems

The computer systems used in blood establishments are often customised to cover their specific needs (Blood Establishment Computer System - BECS). The US American Food and Drug Administration (FDA) has now published a Guidance for Industry "Blood Establishment Computer System Validation in the User's Facility". This document is intended to assist blood establishments in developing a validation programme for their IT systems. It contains the good practices from software validation, quality assurance and software development.
It is expressly stated that this guide does not address the software manufacturer's validation responsibilities.

The Guidance for Industry is divided into 4 main chapters:

I. Introduction
II. Background
III. Discussion
IV. References

The main chapter "Background" includes the following subchapters:

A. Description of Blood Establishment Computer System
B. Description of Blood Establishment Computer Software
C. Definitions and Terminology

It is pointed out in the guidance that such systems are also regulated under the following paragraphs of the Code of Regulation (CFR):
- 21 CFR Part 606 - specifically Part 606.60 (Current Good Manufacturing Practice for Blood and Blood Components)
- 21 CFR Part 211 - specifically Part 211.68 (Subpart D (Equipment))

To avoid common confusion between the terms "validation", "verification" and "testing", the FDA has given a definition for each of them. The largest main chapter "Discussion" is fairly detailed about the specific aspects of validation like:

A. Vendor Selection of BECS (with a reference list of 510(k) approved software (see Literature))
B. System Documentation
C. Validation Plan
D. Scope of Validation
E. Risk Assessment
F. Validation Procedures
G. Validation Activities
H. Validation Report
I. Validation after a Change
J. Integrated Package vs. Stand-Alone

Here again, throughout references are made to chapters and sections of 21 CFR Part 606 and 21 CFR Part 211.

All in all, this Guidance for Industry is a quite clear and informative document which takes into consideration blood establishments' specific needs.


- Guidance for Industry "Blood Establishment Computer System Validation in the User's Facility"
- Definition 510(k)
- Reference List 

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