Records must:
Be kept as original records, true copies (such as photocopies, pictures, scanned copies, microfilm, microfiche, or other accurate reproductions of the original records), or electronic records;
Contain the actual values and observations obtained during monitoring and as appropriate, during verification activities;
Be accurate, indelible, and legible;
Be created concurrently with performance of the activity documented; and
Be as detailed as necessary to provide history of work performed.
All records must include:
Information adequate to identify the plant or facility (e.g., the name, and when necessary, the location of the plant or facility);
The date and, when appropriate, the time of the activity documented;
The signature or initials of the person performing the activity; and
Where appropriate, the identity of the product and the lot code, if any.
Records that are established or maintained to satisfy the requirements of this part and that meet the definition of electronic records in § 11.3(b)(6) of this chapter are exempt from the requirements of part 11 of this chapter. Records that satisfy the requirements of this part, but that also are required under other applicable statutory provisions or regulations, remain subject to part 11 of this chapter.
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