Page 19 - Pharmaceutical M5 Biopharma

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Sponsored Feature  19

Total Solution for Regulatory Compliance

Data integrity compliance has become one of the most important components of the pharmaceutical industry’s responsibility
to ensure the safety, efficiency and quality of drugs to protect human health. However, regulatory agencies have observed an
increasing number of Current Good Manufacturing Practice (CGMP) violations related to data integrity in recent years.
Regulatory agencies expect data to be reliable and accurate on the CGMP criteria for all laboratory instruments, including
UV-Vis and FT-IR, as well as all other standalone instruments.
Shimadzu offers the LabSolutions CS platform, the unified network platform that is able to control all Shimadzu instruments
via the network with administrative access control and logging, complete audit trail and reporting functionality to ensure data
integrity compliance.

Poster Presentation Video: Video:
(Pittcon 2018): “Supporting Data Integrity” “Solutions Supporting the
Innovative Solution for the Reliability of Test Data”
Various Instruments in the
Analytical Laboratory

Innovative Solution for the Various Instruments in the Analytical Laboratory
Toshinobu Yanagisawa, Koji Ono, Hiroomi Nishimura, Keisuke Yoshizawa, Ryuji Nishimoto Shimadzu Corporation, Kyoto, Japan
1. Introduction 4. Example of FDA Warning Letter 7. Report Set Function to Support Data Integrity 8. Features of Report Set Function
Data integrity compliance has become one of the most important components of industry’s Case 1. Re-test until acceptable results are obtained
as Data Reports, Acquisition & Processing method reports, activity logs, and audit trail information, and then
responsibility to ensure the safety, efficiency and quality of drugs to protect human health. However, Case 2. Disregard trial test results Report Set is the function in LabSolutions TM CS to automatically combine sets of reports for each batch, such  Visibility of the series of analysis operations reduces the work involved in
regulatory agencies have increasingly observed Current Good Manufacturing Practice (CGMP) Case 3. Torn raw data records in the waste area digitally consolidate them into a single PDF file. checking results and ensures reliability
violations related to data integrity during inspections in recent years. Case 4. No audit trail for UV spectrophotometer Report Set consolidates all the necessary information in a single PDF file, so that the
This is because not only the role of data integrity on the CGMP requirements is not well understood, Table 1 Categories and remedies for issues raised by regulatory agency Batch file HPLC, GC, LC-MS, UV-Vis, FTIR and RF are supported entire series of analysis operations including data processing are easily visible. As a result,
but the scope of data integrity is more than earlier expectations in the analytical laboratory. Category Description Examples of Issues Remedies Analysis Information Method Reports it is not necessary to switch between a number of windows or tabs in the software to check
Regulatory agencies expect that data must be reliable and accurate on the CGMP criteria for all Problems with inadequate • Paper-based test results did not • Regulatory requirements should operations and settings as part of data review.
laboratory instruments, including UV-Vis and FT-IR, as well as all other standalone instruments to 1 recognition contain all meta data information. be interpreted correctly. Data PDF
the same level of chromatographs. • There were no audit trail functions. • Systems should be updated to  The series of analysis results is automatically protected against modification
Here, it is shown how data integrity compliance is effectively achieved on a unified network platform 2 Functional deficiencies, • Login IDs and passwords were enable compliance with Data Report Set Once a digital link is created between the series of analysis results (electronic
regulations.
• System settings should be
inadequate settings, and
• Data deletion was not restricted
usage issues
being shared.
in the analytical laboratory.
using user rights.
data) and the report set, editing is automatically disabled (locked). This helps to
2. Guidance for Data Integrity Issued by • Tests were repeated until specified appropriately. Log Data Reports prevent any data modification, such as replacing or deleting the analysis results.
The digital link created not only ensures a unique relationship between the report
Regulatory Agencies 3 issues Testing process reliability • Out-of-specification (OOS) data • Operations should be checked Data Fig. 3 Schematic diagram of Report Set function set and the analysis results (electronic data), but also enables analysis results
acceptable results were obtained.
was neither investigated nor
(electronic data) to be searched and reviewed quickly.
for any improper actions.
Guidance for data integrity has been published by regulatory agencies such as MHRA, FDA and reported. Data files are automatically
locked & can not be edited
PIC/S in recent years. Create Report Set unless unlocked by  Enhanced productivity thanks to digitization of the confirmation process for
March GMP Data Integrity Definitions and Guidance for Industry : 5. Actual Situation in the Regulated Laboratory authorized user. the analysis results report
2015 MHRA (UK) The guideline for data integrity is focusing on review of audit trail.
April Guidance for Industry Data Integrity and Compliance With CGMP : The following points should be checked: Initiate Acquire Check the contents of The Report Confirmation function can be used to retain evidence that the content
of the chromatogram report included in the PDF file was reviewed.
 Data is acquired by the predefined batch and method condition.
2016 FDA (USA)  Data is reprocessed only by a privileged user. Report Set The confirmation form can be designed anywhere in the chromatogram report in
July MHRA GxP Data Integrity Definitions and Guidance for Industry :  The contents and reasons for the reprocessing are reasonable. Process The confirmation assistant function is included to ensure content reliability by
the same way as other analysis information.
2016 MHRA (UK)  Acquisition is not terminated or paused except for any compelling reason. emitting an error to provide notification of unchecked items.
Electronic signatures can be applied for Report Set review and approval processes, and linked data is also
August PIC/S Good Practices for Data Management and Integrity in Regulated  No orphan data exists. Retention reviewed and approved at the same time.
2016 GMP/GDP Environments [PI 041-1(Draft2)] : PIC/S  Assure the data is not modified during the data lifecycle Sign off Report Set
 Review all meta data related to the samples
Data files included in Report Set are locked
3. Ensuring Data Integrity Compliance  Prevent human error to reprocess data Retrieval Destruction and electronic signatures are applied on the 9. Conclusion
 Secure the storage area
A recent topic related to analytical data is the lack of data integrity due to data modification and replacement.
original data files.
The data integrity compliance is required for all instruments to the same level of chromatographs Fig. 2 Data lifecycle management Fig. 4 Operation flow by LabSolutions CS software Shimadzu LabSolutions CS is a Unified Network Platform for various instruments and provides the solution to
A unified network platform for various instruments reduces human error risk and system 6. Issues to be Solved ensure data integrity while improving security and usability.
especially focusing on data security and centralized storage.
maintenance cost in the laboratory. approver must print, review and archive all meta data. innovative Realize Advanced Laboratory
In order to confirm that the data is appropriately acquired by the predefined batch and method condition,
A Attributable to the person generating the data Time Consuming  Support various instruments in the laboratory
 Consolidate all information for data integrity inspection in a single PDF file
L Legible and permanent The significant amount of time needed for analysis report printing, intuitive Achieve Easier Operation
C Contemporaneous Space Occupation Data confirmation results can be checked  Process large amount of data and confirm the results on a single platform
summarization, checking and storage tasks can interfere with daily
operations.
O Original record (or true copy) The increasing number of binders required to store printouts can cause using LabSolutions CS Data Manager.
 Generate Report Set with 1-click operation
storage space problems.
A Accurate Unified Instrument Network Alteration Risk The confirmation form can be designed anywhere in intelligent Increase Work Efficiency
 Lock and sign-off all the data files linked to Report Set
If there are any unchecked items in the data report,
the data report.
+ Complete, Consistent, Enduring, Available an error is shown to prevent confirmation omissions  Reduce human error risk and system maintenance cost
Fig. 1 Unified network platform for various instruments or authorization. Analysis results might be modified or discarded without proper approval Fig. 5 Prevention of confirmation omissions
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