Irwin Memorial Blood Centers 3/20/97 Blood Center
Please be advised that the agency’s memorandum dated April 6, 1988, entitled “Recommendations for Implementation of Computerization in Blood Establishments” indicates as a data security issue that “if key elements of the database are changed, these changes should be traceable as to the time and person making the changes so that integrity and reproducibility of data are assured.” In addition, the agency’s memorandum dated September 8, 1989, “Requirements for Computerization of Blood Establishments” states that among other requirements, “Security procedures to prevent unauthorized entry and physical access to the computer system” and “Procedure for control of changes in hardware/software” must be incorporated into SOPs. Copies of both these memoranda were provided to your firm with the Warning Letter dated January 13, 1993 and are enclosed with this letter.
