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C101-E149

Sample Measurement Report
(1) Select a file. * 6 Information List Log * 7
Data Manager Window
Technical Data Integrity Compliance: An Innovative
Report Solution for Molecular Spectroscopy
A Report Set (a single PDF file) is generated
in the database, and the data is locked. * 8 Measurement Audit
Parameters Trail
PDF (3) The Report Set * is complete.
9
Data Manager Window Mamoru Kikumoto 1

Abstract:

A recent topic related to analytical data is the lack of data integrity due to data modification and replacement. Regulatory authorities for
analytical instruments are not only interested in chromatography systems, such as liquid chromatographs (LC) and gas chromatographs
(GC), but are also turning their interest to spectroscopy systems, such as UV and IR systems. Consequently, many analytical laboratories are
Because data lines with electronic
approval are color-coded, they can urgently considering how to ensure data integrity for spectroscopy systems. This report describes an innovative solution for ensuring data
(2) Right-click, and select [Create Report Set]. be easily distinguished from integrity for such spectroscopy systems.
remaining data that has not been
reviewed or approved, which makes Keywords: Data integrity, spectroscopy system, and orphan data
it easy to find any orphan data.
Fig. 2 Procedure for Using LabSolutions to Create a Report Set for Spectroscopy Systems * 6
*6: If one UV photometric data file is selected for creating a report set, then the created report set will include files related to the selected file. 3)
1. References to Spectroscopy
If there are multiple related files for UV, FTIR, or RF confirmation testing, then the related files are selected manually. 1. Refer ences to Spectr oscopy • WHO (World Health Organization)
Systems by Regulatory Authorities
*7: The log file includes information recorded during measurements (a log record of operations performed between logging in for measurements and logging out). If postrun analysis is Systems by Regulatory Authorities
performed, a postrun analysis log is recorded (a log record of operations performed between logging in for postrun analysis and logging out) separately from the measurement log. Original dynamic electronic spectral files created by FT-IR, UV/Vis,
*8: Locked files can only be unlocked by people with the right to do so. and chromatography instruments can be reprocessed, but a pdf or
*9: For UV, FTIR, and RF report sets, support for functions (1) to (3) will be available in the future. Compliance with data integrity requirements is already a pressing
(1) Assigning ID codes to measurement methods (2) Avoiding superimposed printing of measurement methods for multiple sets of data issue for companies that require GxP compliance. In addition to printout is fixed or static and the ability to expand baselines, view
(3) Measuring sequences. However, this is already supported for UV quantitative testing (photometric). See *6. the full spectrum, reprocess and interact dynamically with the data
chromatography systems, such as LC and GC systems, regulatory
Reference authorities have now turned their attention to spectroscopy sys- set would be lost in the PDF or printout.
[1] MHRA. “MHRA GxP Data Integrity Definitions and Guidance for Industry （Draft version for consultation）”. July 21, 2016, p. 3. tems, such as UV and IR spectrophotometers. (See below.)
https://www.gov.uk/government/news/mhra-gxp-data-integrity-definitions-and-guidance-for-industry, （accessed May 30, 2017） .
[2] FDA. “Data Integrity and Compliance With CGMP Guidance for Industry（DRAFT GUIDANCE）”. April, 2016, p. 7. • PIC/S 4)
http://www.fda.gov/ucm/groups/fdagov-public/@fdagov-drugs-gen/documents/document/ucm495891.pdf, （accessed May 30, 2017） . • MHRA (Medicines and Healthcare products Regulatory
[3] WHO. “WHO Expert Committee on specifications for pharmaceutical preparations （Fiftieth report） ; Annex 5: Guidance on good data and record management practices”. Agency) 1) QC supervisors and managers should not be assigned as the system
May, 2016, pp. 206−207. http://www.who.int/medicines/publications/pharmprep/trs_996/en/, （accessed May 30, 2017） . administrators for electronic systems in their laboratories (e.g.,
[4] PIC/S. “Draft PIC/S Good Practices for Data Management and Integrity in Regulated GMP/GDP Environments”. August 10, 2016, p. 28. It is common for companies to overlook systems of apparent lower HPLC, GC, UV-Vis).
https://www.picscheme.org/en/publications#selSection_Guidance documents, （accessed May 30, 2017） .
[5] PMDA. "Current PIC/S GMP Trends and PMDA Issues". 2016 43rd GMP Case Study Workshop (Japan Pharmaceutical Manufacturers Association) September complexity. However, with these systems, it may be possible to ma-
12-15, 2016, p. 30. nipulate data or repeat testing to achieve a desired outcome with • PMDA (Pharmaceuticals and Medical Devices Agency) 5)
http://www.jpma.or.jp/information/quality/pdf/161006_1.pdf,(accessedMay30,2017). limited opportunity for detection (e.g. stand-alone systems with a
[6] FDA. “Teva Pharmaceutical Works Private Limited Company 10/13/16”. Warning Letter: 320-17-01. October 13, 2016. Ensuring appropriate data integrity:
http://www.fda.gov/iceci/enforcementactions/warningletters/2016/ucm525640.htm, （accessed May 30, 2017） . user-configurable output such as ECG machines, FTIR, UV spectro-
[7] FDA. “Yunnan Hande Bio-Tech. Co. Ltd. 4/6/15”. Warning Letter: 320-15-09. April 6, 2015. photometers). The following practices never occur in workplaces, do they?
http://www.fda.gov/iceci/enforcementactions/warningletters/2015/ucm443247.htm, （accessed May 30, 2017） . PDF files of past IR test results are modified and printed.
[8] Paul Smith. “Data Integrity in the Analytical Laboratory”. Pharmaceutical Technology. May 2, 2014.
http://www.pharmtech.com/data-integrity-analytical-laboratory?pageID=1, （accessed March 7, 2016） . • FDA (U.S. Food and Drug Administration) 2) == > Recycling test results
[9] Mamoru Kikumoto. "Data Integrity Compliance Using the LabSolutions Report Set". UHPLC/HPLC, LC/MS Technical Report C191-E041, Shimadzu Cooperation.
March, 2016. http://www.an.shimadzu.co.jp/hplc/prominence/tec.htm, (accessed May 30, 2017). For example, a spectral file created by FT-IR (Fourier transform infra-
red spectroscopy) can be reprocessed, but a static record or printout The above shows that regulatory authorities are not only interested
First Edition: November, 2017 in chromatography systems, such as LC and GC systems, but are
is fixed. This does not satisfy CGMP requirements to retain original
also turning their attention to spectroscopy systems, such as UV and
records or true copies (§ 211.180(d)).
IR systems.

© Shimadzu Corporation, 2017 1 Analytical & Measuring Instruments Division 1