Yes. We build and manage IT for HCT/P establishments regulated under 21 CFR Part 1271, including donor-eligibility recordkeeping under Subpart C and current good tissue practice under Subpart D. We know that FDA expects you to track any graft from donor to recipient and to retain records for years after distribution, transplantation, or expiration. Our job is to make sure your systems, backups, and documentation support those obligations rather than jeopardize them. We also align your environment with AATB accreditation expectations for traceability, validation, and confidentiality. That means your infrastructure is ready when an inspector or accreditation surveyor arrives.


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