CBER Tissue/Cell Compliance Policy Guide

FDA’s Center for Biologics Evaluation and Research issued the following:

“Compliance Program Inspection of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) 7341.002”

This guide mentions software and computer systems in one paragraph which is provided below:
“Computers: The performance of computer software must be validated (if customized) or verified (if used “off-the-shelf”) for the intended use if the firm relies upon it to comply with core CGTP requirements. Requirements are outlined in 21 CFR 1271.160(d). If the firm is using a computerized record-keeping/ tracking system, ensure the integrity of records is maintained and traceability of all HCT/Ps from donor to the consignee or final disposition; and from the consignee or final disposition to the donor. ”

Keywords: BECS, Blood Establishment, CBER

Software Verification

Do you have gaps with IEC 62304 compliance or with FDA expectations for software verification?  We can help you quickly remediate gaps with unit verification including unit testing, code review, and static analysis, as well as integration and system verification testing.  Call us at 781-721-2921 or email office@softwarecpr.com to start a conversation.  We can provide estimates of cost and support your development tools.

Corporate Office

15148 Springview St
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN) and Italy.