Minn. R. 4740.2097 - RECORDS RETENTION AND RETRIEVAL
A. The record-keeping system must allow
historical reconstruction of all laboratory activities that produced the
analytical data. This also applies to interlaboratory transfers of samples or
extracts and the data resulting from the analysis of the samples or
extracts.
B. Unless otherwise
required by permit, program, or rule, all records must be retained for a
minimum of five years after generation of the last entry in the record. All
information required for the historical reconstruction of the data must be
maintained by the laboratory. If records are retained only in electronic form,
the hardware and software required for the retrieval of electronic records must
be retained for the same time period as the records to be retrieved.
C. The records must include the identity of
personnel designated by the laboratory as responsible for the task performed,
as described in the person's job description. The laboratory must retain
records of the signatures and initials of designated personnel.
D. All information relating to the laboratory
facilities, equipment, analytical test methods, and related laboratory
activities, such as sample receipt, sample preparation, or data verification,
must be documented.
E. The
record-keeping system must allow the retrieval of all working files and
archived records for inspection and verification purposes, including but not
limited to systematic naming of electronic files.
F. All records must be signed or initialed by
personnel designated by the laboratory as responsible for the task performed.
All changes must be clearly indicated in the records. The laboratory must have
procedures for recording changes and identifying the personnel making the
change.
G. All observations used to
calculate the final result must be recorded immediately. If the record is
handwritten, the record must be legible and in permanent ink.
H. Entries in records must not be obliterated
by methods such as erasures, overwritten files, or markings. All corrections to
records on paper must be made by one line marked through the error. The
individual making the correction must sign or initial and date the handwritten
or electronic correction.
I. A
laboratory must maintain a record-keeping system that includes procedures for
protecting the integrity and security of the data.
J. A laboratory must supply any documentation
or data listed in parts 4740.2010 to 4740.2120 within 30 days of the date that
the commissioner requests the information.
Notes
Statutory Authority: MS s 144.97; 144.98
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