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

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Our cybersecurity experts are NESSUS Pro Licensed and can quickly remediate cybersecurity deficiencies with your medical device or digital health software.  Planning, requirements, validation, and submissions – we can assist with all.

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