Health Physics Questions and Answers - Question 141

Question 141: 10 CFR 20.2110 requires adequate safeguards against tampering with and loss of records. For data stored in electronic systems, what safeguards are acceptable?

Answer: The NRC does not have, and has no plans to develop, prescriptive requirements or guidance on safeguards for electronic systems to prevent tampering with or loss of records. However, the Electric Power Research Institute (EPRI) has published a report, "Guidelines for Quality Records in Electronic Media for Nuclear Facilities (NCIG-10)," Report No. EPRI NP-6295 (May 1989) that may be helpful in meeting this requirement in 10 CFR 20.2110. The NRC staff has taken no position in regard to this EPRI document. The abstract of this report includes the statement that the guidelines in the report "provide a consistent approach to the electronic creation, storage, retrieval, control and approval of quality records, a subject heretofore not addressed by industry standards and regulations."

(Reference: 10 CFR 20.2110)