CHECKLIST FOR WRITTEN DOCUMENTATION REQUIRED BY THE cGMP

CHECKLIST FOR WRITTEN DOCUMENTATION REQUIRED BY THE 21 CFR 803 (MDR) and 21 CFR 820(QSR, cGMP)

*Required Procedures*	*21 CFR Section*	*Check*
Procedures for MDRs	*803.17*
A documented quality program	*820.20*
Documentation of Management review of quality system at defined intervals and at sufficient frequency	*820.20*
Procedures for audits	*820.22*
Records of audits	*820.22*
Procedures for identifying training needs	*820.25*
Documentation of any necessary personnel training programs	*820.25*
Documents relating to design controls including the Design History File	*820.30*
Procedures for specification control measures to assure that device, components , and packaging design results in approved specifications	*820.40*
Document controls not previously mentioned	*820.40*
Document of specification changes	*820.40*
Procedure of approval of change of manufacturing process	*820.40*
Record of percentage of defective components for each lot and the percentage of lots rejected	*820.50*
Purchasing controls not previously mentioned	*820.50*
Limitations or allowable tolerances on equipment	*820.70*
Records of equipment inspections	*820.70*
Procedures and specifications for manufacturing processes	*820.70*
Records of maintenance activities	*820.70*
Procedures for processing control	*820.70*
Documentation of inspections of any required environmental control system	*820.70*
Procedures for contamination control	*820.70*
Procedures and schedules for maintenance, adjustment, and cleaning of equipment	*820.70*
Procedures for use and removal of manufacturing material	*820.70*
Record of removal of manufacturing material	*820.70*
Procedure for approval of changes to software programs	*820.70*
Procedures for acceptance of components	*820.80*
Records of acceptance or rejection of components	*820.80*
Procedures for finished device inspection and sampling plans	*820.80*
Documentation of testing of computer software programs for calibrating, inspecting, and checking measurement equipment	*820.84*
Procedures for calibration, inspection, and checking of measurement equipment	*820.84*
Procedures and limits for accuracy and precision in calibration of measurement equipment	*820.84*
Records documenting traceability of calibration standards	*820.84*
Records of calibration, inspection, and checking of measurement equipment	*820.84*
Records of calibration of measurement equipment	*820.84*
Procedures for reprocessing of devices or components	*820.90*
Record (implied) of final inspection of reprocessed device	*820.90*
Records of the disposition of obsolete, rejected, or deteriorated components	*820.90*
Records of investigation of failure of device or components after release for distribution	*820.100*
Procedures for warehouse control and distribution of finished devices Where necessary, system to assure that oldest approved devices are distributed first	*820.124*
Record of examination of labeling materials	*820.162*
Device Master Record	*820.181*
Device History Record	*820.184*
Record of critical operations in device history records by responsible individual	*820.184*
Records of written and oral complaints	*820.198*
Record of complaint investigation or reason no investigation was done	*820.198*
Complaints pertaining to injury, death, or any hazard to safety	*820.198*
Servicing procedures, records, and record evaluations	*820.200*
Statistical techniques: identification of valid techniques, sampling plans, adequacy	*820.250*