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Report sets consolidate all the necessary information in a single PDF file, Problem 1 Associated with Printouts
so that the entire series of operations involved in the analysis (and post- The significant amount of time needed for analysis report printing, summariza-
run analysis) are easily visible. With the same feel as an electronic book, tion, checking, and storage tasks can interfere with daily operations.
you can check the details while turning the pages. As a result, it is not
necessary to switch between a number of windows or tabs to check op-
erations and settings as in the past. In this way, the Report Set function
reduces the work involved in checking results and ensures reliability. Problem 2 Associated with Printouts
«Feature 2» The increasing number of binders required to store printouts can cause storage
Link space problems.
The Series of Analysis Results Is Auto-
PDF
matically Protected Against Modifica-
tion
.pdf
Once a digital link is created between the series of analysis results Storage binder
(electronic data) and the report set for which visibility is being provided,
editing is automatically disabled (locked). This will help prevent any Problem 3 Associated with Printouts
data modification, such as replacing or deleting the analysis results. Analysis results might be replaced or discarded.
The digital link created between the data not only ensures a unique
relationship between the report set the analysis results (electronic
data), but it also enables analysis results (electronic data) to be
searched and checked quickly. Replacement Disposal
«Feature 3»
Paperless
Enhanced Productivity Thanks to Dig-
PDF OK
itization of the Confirmation Process
Fig. 4 Problems Associated with Printouts
for the Analysis Results Report OK
Electronic signatures can be used for report set review and approval
The Report Confirmation function can be OK
Electronic signature processes, with the original source electronic data (analysis results data)
used to retain evidence that the content also being reviewed and approved at the same time. Using electronic
of the chromatogram report included in the PDF file was reviewed. This signatures means electronically signed reports do not necessarily need
evidence can be left anywhere in the chromatogram report in the to be printed out and signed by hand. Consequently, migrating to a
same way as with printouts. A confirmation assistant function is includ- paperless work flow can solve the problems associated with printouts
ed to ensure content reliability by emitting an error to provide notifica- (see Fig. 4) and reduce the time required to check various results by one
tion of unchecked items.
half to a third of that previously required.
The Report Set function is included in LabSolutions, which increases
CSV efficiency because a separate validation process is not necessary.
References
1) ORA FOIA Electronic Reading Room. July 6, 2005.
http://www.fda.gov/AboutFDA/CentersOffices/OfficeofGlobalRegulatoryOperationsandPolicy/ORA/ORAElectronicReadingRoom/ucm061813.htm, (accessed March 7, 2016).
2) R. D. McDowall. Quality Assurance Journal. 2006. Volume 10, Issue 1, pp. 15–20, doi:10.1002/qaj.357. http://onlinelibrary.wiley.com/doi/10.1002/qaj.357/pdf,
(accessed March 7, 2016).
3) FDA. U.S. Department of Justice Press Release. March 8, 2007. http://www.fda.gov/ICECI/CriminalInvestigations/ucm258236.htm, (accessed March 7, 2016).
4) http://www.gmp-compliance.org/eca_index.html (Note: The ECA (European Compliance Academy) is a non-profit organization established in the EU in 1999 that
provides GMP training and conferences for the pharmaceutical industry. About 4000 members of it are from over 60 countries, mainly in Europe.)
5) ECA. “Data Integrity: New Inspection Focus of the FDA”. GMP News. February 25, 2015.
http://www.gmp-compliance.org/enews_04704_Data-Integrity-New-Inspection-Focus-of-the-FDA.html, (accessed March 7, 2016).
6) 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).
7) Keiko Bansho. Chapter 5 Operations and Management for Paper-Based and Electronic Data for Compliance with Regulations by the Three Authorities. Recording and
Managing Data and Migration to Digitization at Laboratories Based on the Issues Raised by the Three Authorities. Science & Technology, May 15, 2015, pp. 127−146

First Edition: December, 2016

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