FDA publishes Guidance for Industry: Blood Establishment Computer System Validation in the User's Facility

In March, the FDA published a Guidance for Industry: Blood Establishment Computer System Validation in the User's Facility. This document is supposed to assist blood establishments in developing a blood establishment computer system validation program, consistent with recognized principles of software validation, quality assurance, and current good software engineering practices.

the following background will be the base of the special requirements for Computer Systems in Blood Establishments:

A. Description of Blood Establishment Computer System
A Blood Establishment Computer System (system) includes: computer hardware; computer software; peripheral devices; networks; personnel; and documentation, e.g., User’s Manuals and Standard Operating Procedures (SOPs). The computer software used in a system includes BECS, which is a medical device. Systems are also regulated as equipment under 21 CFR Part 606 (Current Good Manufacturing Practice for Blood and Blood Components), specifically 21 CFR 606.60, and as automated or electronic equipment under 21 CFR Part 211, Subpart D (Equipment), specifically 21 CFR 211.68.

B. Description of Blood Establishment Computer Software
BECS is software designed to be used in a blood establishment and is intended for use in the diagnosis of disease or other conditions in donors, or in the prevention of disease in humans by preventing the release of unsuitable blood and blood components. Some of the intended uses of BECS include:

  • Use during the manufacturing process for determining donor eligibility and release of the blood or blood component as suitable for transfusion or further manufacture;
  • Use in transfusion services to perform compatibility testing and other related functions;
  • Use to establish positive patient identification prior to transfusion by scanning machine readable information such as barcodes on patient wristbands (or other electronic data storage items), specimen containers, and blood product labels; and
  • Use to perform other functions associated with transfusion, such as recording patient vital signs and tracking blood products.

This guidance describes the following:

  • Requirements in Title 21 Code of Federal Regulations (21 CFR) (e.g., 21 CFR 211.68, 606.100(b), and 606.160) that apply to blood establishment validation of systems; and
  • FDA’s recommendations for the validation of systems.

This guidance finalises the draft guidance entitled “Guidance for Industry:  Blood Establishment Computer System Validation in the User’s Facility” dated October 2007.

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