Quality Management
21 CFR Part 1271.160 Subpart D mandates that an organization that performs any step in the manufacture of HCT/Ps must establish and maintain an effective quality program. An electronic quality management system (QMS) can facilitate compliance with CGTP quality requirements by automating and integrating quality-related tasks, standardizing and streamlining operations and promoting efficiency.
Written Procedures
21 CFR Part 1271 Subparts C and D and 21 CFR Part 1270.31 require that written procedures must be prepared and followed for all significant operational steps and that associated records must be maintained. A QMS solution simplifies compliance with these requirements by centralizing document databases and automating document routing, approvals, escalations and revision control.
Inspection Readiness
21 CFR 1271.400 Subpart F and 21 CFR Part 1270.41 Subpart D state that the FDA may inspect HCT/P manufacturing locations at any time to determine compliance. Robust QMS solutions enable companies to maintain inspection readiness by storing documents and records in an accessible web-based repository where they can be easily located and retrieved during inspections or audits.
Software Validation
21 CFR Part 1271.160 Subpart D states that software used during the fulfillment of any tissue processing steps must be compliant with core CGTP requirements. A CGTP-compliant software solution can ensure continuous validation and dramatically reduce the time, pain and costs involved in validation.
