Regulatory library
21 CFR Part 1271
Part 1271 governs human cells, tissues and cellular and tissue-based products (HCT/Ps). Its current good tissue practice rules ask for equipment that is suitable, cleaned, maintained and calibrated, and for controlled storage conditions with records.
ValDoc's library holds 3 provisions of 21 CFR Part 1271. It can apply to URSs for biosafety cabinets, centrifuges, cryogenic systems, controlled temperature units, environmental monitoring, incubators, label printers, stability chambers, sterilization equipment, transport systems, thermal sealing and welding systems and vacuum pumps, depending on their intended use. This page is guidance in our words. The regulation's own text governs.
Last updated
Thirty minutes. Bring one piece of equipment.
Baseline requirements that cite it
- Reusable transport equipment shall support defined cleaning, preparation, inspection and reuse qualification without compromising payload or personnel protection.
- The approved retention schedule shall identify each record class, governing period, accessible format and tested retrieval/archive arrangements throughout the required life.
- Storage controls shall preserve tissue identity/conditions; computerized inventory changes and retained records shall be controlled and recoverable.
- and 2 more
Provisions in ValDoc's library
See your own equipment in ValDoc.
Bring one piece of equipment, or one you plan to buy, and we’ll walk it through ValDoc with you, from its intended use to the signed record.
Thirty minutes. Bring one piece of equipment.