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TITLE 21--FOOD AND DRUGS

CHAPTER I--FOOD AND DRUG ADMINISTRATION

DEPARTMENT OF HEALTH AND HUMAN SERVICES

PART 820--QUALITY SYSTEM REGULATION

NOTE    This section provides the text of Title 21, Volume 8, Part 820 of the Code of Federal Regulations (as revised April 1, 2003). Regulation 21CFR820 represents the US Food and Drug Administration's requirements for good configuration management practices. Our intent is simply to provide insight into accepted configuration management principles in a regulatory environment. While this text is believed to be an accurate transcription of the regulation, if your company is subject to FDA regulation you should obtain the current regulation directly from the Food and Drug Administration.

21 CFR Part 820: Contents

Subpart A	General Provisions
Sec. 820.1	Scope.
Sec. 820.3	Definitions.
Sec. 820.5	Quality system.
Subpart B	Quality System Requirements
Sec. 820.20	Management responsibility.
Sec. 820.22	Quality audit.
Sec. 820.25	Personnel.
Subpart C	Design Controls
Sec. 820.30	Design controls.
Subpart D	Document Controls
Sec. 820.40	Document controls.
Subpart E	Purchasing Controls
Sec. 820.50	Purchasing controls.
Subpart F	Identification and Traceability
Sec. 820.60	Identification and Traceability.
Sec. 820.65	Traceability.
Subpart G	Production and Process Controls
Sec. 820.70	Production and process controls.
Sec. 820.72	Inspection, measuring, and test equipment.
Sec. 820.75	Process validation.
Subpart H	Acceptance Activities
Sec. 820.80	Receiving, in-process, and finished device acceptance.
Sec. 820.86	Acceptance status.
Subpart I	Nonconforming Product
Sec. 820.90	Nonconforming product.
Subpart J	Corrective and Preventive Action
Sec. 820.100	Corrective and preventive action.
Subpart K	Labeling and Packaging Control
Sec. 820.120	Device labeling.
Sec. 820.130	Device packaging.
Subpart L	Handling, Storage, Distribution, and Installation
Sec. 820.140	Handling.
Sec. 820.150	Storage.
Sec. 820.160	Distribution.
Sec. 820.170	Installation
Subpart M	Records
Sec. 820.180	General requirements.
Sec. 820.181	Device master record.
Sec. 820.184	Device history record.
Sec. 820.186	Quality system record.
Sec. 820.198	Complaint files.
Subpart N	Servicing
Sec. 820.200	Servicing.
Subpart O	Statistical Techniques
Sec. 820.250	Statistical techniques.

 

[Code of Federal Regulations]

[Title 21, Volume 8]

[Revised as of April 1, 2003]

From the U.S. Government Printing Office via GPO Access

[CITE: 21CFR820]

 

Rev 2006-11-18 12:03:34 -0700

For correct application of this information, see NOTE on Contents page