Computerization of Blood Establishments (9/8/89)

Date:      September 8, 1989

From:      Director, Center for Biologics Evaluation and Research

Subject:   Requirements for Computerization of Blood
           Establishments

To:        All Registered Blood Establishments

I.  INTRODUCTION

This memorandum is intended to provide further guidance on the
use of computer systems in registered blood establishments as
previously addressed in a memorandum dated April 6, 1988.

Computer systems are being employed more frequently in blood
establishments, not only for recordkeeping, but for activities
intimately involved in processes and procedures integral to the
collection, processing, storage and distribution of blood and
blood components. When personnel depend on the computer system in
making decisions regarding the suitability of donors and the
release of blood or blood products for transfusion or further
manufacture, the computer system is considered to have "control
functions."

Computer systems which perform control functions are subject to
current good manufacturing practices, 21 CFR 211 and 606.
Computer systems, both hardware and software, employed in the
performance of these control functions fall within the meaning of
21 CFR 606.60 (Equipment) and 21 CFR 211.68 (Automatic,
mechanical, and 21 CFR 606.160 (Records).

Computer software used for retention of data relating to donor
suitability and deferral, blood processing (including testing),
component preparation, storage or disposition is subject to all
recordkeeping requirements applicable to manual systems as
prescribed by 21 CFR 606.160 (Records).

Blood establishments using computer systems in control functions
must assure that the computer system performs consistently and as
required in meeting all user requirements. Documentation of
validation criteria and procedures must be maintained, and
computer systems installed or modified after the date of this
memorandum should not be incorporated into daily operations
without initial acceptance testing and management review. The
volume and type of documentation required to validate the
computer system will vary according to the nature and extent of
the control functions and the degree of reliance placed on the
computer system during critical steps in use. Documentation
should clearly show that all components of the computer system
have been qualified and operate properly before final
implementation of the total computer system. For systems that are
currently installed, retrospective review must demonstrate
compliance with 21 CFR 606.60 and 21 CFR 606.160. Documentation
must also demonstrate that the computer system has been properly
challenged and that conversion to and reliance on the system does
not contribute to the release of unsuitable blood products.

II. STANDARD OPERATING PROCEDURES

The following items must be incorporated into standard operating
procedures and be available for review during establishment
inspections of all registered blood establishments: 

     1. Procedures relating to integration of the computer
     system into operations.

     2. Procedures for reverting to manual procedures when the
     system is not functioning.

     3. Back-up procedures for data storage including
     frequency and the disaster recovery plan.

     4. Procedures for the partial or complete shutdown of
     the system or its interfaces to ensure the integrity of
     data and to document proper functioning of the system
     after restarting.

     5. Maintenance procedures for hardware and software.

     6. Security procedures to prevent unauthorized entry
     and physical access to the computer system.

     7. Validation protocols followed to independently test
     and challenge the critical functions and procedures.

     8. Procedures for the active review of system
     functioning and timely correction of errors.

     9. Procedures for control of changes in
     hardware/software.

     10. Procedures for initial and continued training of
     personnel.

III.  RECORDKEEPING

Registered blood establishments must maintain records of the
outcomes of procedures outlined in III above including
identification of personnel involved in performing and reviewing
the procedures. These records must be in compliance with 21 CFR
606.160 and available for review at the time of inspection.

IV. ESTABLISHMENT LICENSE APPLICATIONS/AMENDMENTS

Blood establishments are responsible for assuring that the
computer system repeatably and reliably performs as intended. 
For
LICENSED establishments only, the use of computers in control
Functions constituted a change that must be reported to the
Director, CBER [2lCFR 601.12 (a)].

The following information should be submitted by licensed
establishments in the form of amendments to their establishment
license applications. Submissions should be directed to the 
Director, CBER, through the Division of Product Certification
(HFB-240), 8800 Rockville Pike, Bethesda, MD 20892 within 90
days of the date of this memorandum:

     1. Identification of the source(s) of the application
     software used in control functions and the current
     version(s) in use.

     2. A description of the control functions to be
     performed by the computer system.

V. QUESTIONS AND COMMENTS
Please refer questions concerning licensing to the Division of
product Certification, HFB-240, (301) 443-5433. Other questions
should be referred to the Division of Blood and Blood Products,
HFB-400, (301) 496-4396.


                        Paul D. Parkman, M.D.