Document: NRC Regulatory Guide
Document ID: ed595a39-2817-46a5-93dd-476899712ff9
Document Type: regulatory_guide
Title: 10/2017 (Rev. 5)
Source: NRC Regulatory Guide Division 1
Source URL: https://www.nrc.gov/docs/ML1720/ML17207A293.pdf
Revision Date: 2023-06
Chapter: 
Section ID: RG-1.28
CFR Part: 
CFR Title: 

Content:
endix B to 10 CFR Part 50, that it maintains sufficient records to furnish evidence of activities affecting quality. b. Managing Quality Assurance Records in Electronic Media (1) For the management of electronic records, appropriate controls on quality assurance include the following: (a) No deletion or modification of records unless authorized pursuant to the record retention rule (b) Redundancy (system backup, dual storage, etc.) is provided (c) Legibility is required of each record (d) Records media are properly maintained (e) Inspections to ensure no degradation of records (f) Records are acceptably converted into any new system before the old system is taken out of service The Nuclear Information and Records Management Association (NIRMA) technical guides (TGs), as listed below, provide guidance to establish the appropriate quality controls that incorporates the implementation of enterprise content management systems, web-based technologies, and higher capacity LAN/WAN networks. The NRC approves for use the 2011 versions of the NIRMA TGs. (a) NIRMA TG 11, “Authentication of Records and Media” (Ref. 14); (b) NIRMA TG 15, “Management of Electronic Records” (Ref. 15); (c) NIRMA TG 16, “Software Configuration Management and Quality Assurance” (Ref. 16); and (d) NIRMA TG 21, “Electronic Records Protection and Restoration” (Ref. 17). RG 1.28, Page 8 4. Audits (NQA-1 Requirements 7 & 18) a. Internal Audits (1) Applicable elements of an organization’s QA program should be audited at least once each year or at least once during the life of the activity, whichever is shorter. In determining the scope of the audit, an evaluation of the activity being audited may be useful. The evaluation may include results of previous QA program audits and the results of audits from other sources, including the nature and frequency of identified deficiencies and any significant changes in personnel, the organization, or the QA program. b. External Audits (1) After the