CFR section
21 CFR 1271.160(d): Establishment and maintenance of a quality program
PART 1271-HUMAN CELLS, TISSUES, AND CELLULAR AND TISSUE-BASED PRODUCTS · Subpart D-Current Good Tissue Practice
Key facts
| Citation | 21 CFR 1271.160(d) |
|---|---|
| Section | Establishment and maintenance of a quality program |
| Part | PART 1271-HUMAN CELLS, TISSUES, AND CELLULAR AND TISSUE-BASED PRODUCTS |
| Subpart | Subpart D-Current Good Tissue Practice |
| Subchapter | 21 CFR L Other |
| Product types cited | Biologics, Devices, Drugs, Other_Regulations |
| Regulation text (excerpt) | (d) Computers. You must validate the performance of computer software for the intended use, and the performance of any changes to that software for the intended use, if you rely upon the software to comply with core CGTP requirements and if the software either is custom software or is commercially available software that has been customized or programmed (including software programmed to perform a user defined calculation or table) to perform a function related to core CGTP requirements. You… |
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About CFR sections cited by the FDA
Title 21 of the Code of Federal Regulations contains the FDA's regulations, including current good manufacturing practice and quality system requirements that inspections cite.