Company: Stough Enterprises
Date: 4/18/01
Product: Blood & Plasma
Product Category: Biologics/Blood
Failure to appropriately determine the suitability of donors prior to the collection and distribution of the blood product because on January 30, 2001, a donor screener was observed reading the questions too quickly for the donor to respond prior to the screener entering the information into the computerized system and another donor screener was observed asking the questions while the donor was watching the pre-donation video [21 CFR 640.63(d)].
Lack of proper validation protocols and the maintenance of complete and accurate documentation of the performance of the validation protocols and an analysis of the results for the computerized system, Plasma Center Module [21 CFR 606.160 and 21 CFR 211.68(b)].
Failure to establish and implement adequate computer security to assure data integrity in that during this inspection it was observed that an employee was found to have utilized another person’s computer access to enter data into the Plasma Center Module computerized record keeping system [21 CFR 211.68(b)]. Review 21 CFR 11 for regulations pertaining to the utilization of electronic records and signatures, and security controls pertaining to both.
FDA District: Minneapolis District
SoftwareCPR Keywords: Part 11 Electronic Records;Electronic Signatures, Blood Bank
