Page 9 - Pharmaceutical-Shimadzu Total Solution PICS & FDA Compliance

Shimadzu Multi Data Report Achieves

Regulatory Compliance

Multi Data Report solves the Excel problems. Multi Data Report Meets All Regulatory Requirements

Excel Problems 1 Audit trail problems "Multi Data Report" registers pre-created templates to a database. When a The report that calculated the results is also saved and managed in the
Difficult to identify the creator, date and time of registered data report is generated, it automatically selects the template, pulls required data database. Consequently, the user does not directly touch the data, thereby
Impossible to know who changed values or formula and when from the database and conducts the calculations. Through this procedure, maintaining the access control, audit trail, and protection and security of
only templates and data already in the database are used for calculations. data.
Solutions by Shimadzu Multi Data Report 2 Data security and integrity problems
No means to prevent overwriting or deleting files
No macros are required, only sheet functions are used,
"DDFTT DPOUSPM Templates are saved in a secure database. 7BMJEBUJPO making validation simple.
3 Electronic signature problems Validated templates are controlled in a database.
No electronic signature functions available
Database records secure audit trail.
"VEJU USBJM 1%' SFQPSU Reports are automatically created as PDF files.
Possible to apply electronic signatures on reports.
Features of Multi Data Reports
1SPUFDUJPO BOE Transcription of data is not required.
Simple system creation Easier report generation TFDVSJUZ PG EBUB Data in database cannot be changed. &BTZ UP VTF This eliminates the time needed to re-check data to
prevent errors in transcription.
Easily create report templates as flexible as Excel sheets by visual operation. Generate reports automatically by simply selecting analysis data and report
Created templates are easily registered to the database for secure templates registered in the database.
management using the registration tool. This reduces the workload before In addition, reports are created simultaneously when an analysis ends using
operation of the system. the analysis schedule. No manual input is required, saving effort for report Basic Points on Excel validation
generation and checking. Verified templates for system suitability tests,
GAMP classified Excel as "Category 3" - No individual validation of the package required.
content uniformity tests, and other standard tests are provided as standard.
Validation of formula is required, despite being classified as "category 3".
Automatic generation of PDF files Automatic database registration Control of the software version number, training, and validation (IQ, OQ, PQ) of the system are required.
GAMP classification category 5 is applied if macros are used, such that full validation is required.
A PDF file is generated automatically at the same time a report file is Created reports are automatically saved in the database for secure storage.
created. The excellent portability of PDF files is effective for electronic report Required reports and analysis data can be easily found and recalled using the
transfer. associated information that is automatically registered simultaneously.

Electronic signature-compatible
Electronic signatures can be applied to reports using standard functions of
LabSolutions Data Manager.
Enabling Report Creation for Various Instruments

LabSolutions' Data Manager can prepare integrated reports using analysis data and results obtained from various instruments. Not only can reports be created
Automatic Report Generation by Batch Analysis for HPLC, GC, MS, FTIR, UV, balances, and other instruments individually, but they can include combined data from several instruments.
Enables automatic printing of prepared reports and automatic generation of PDF files.
Create a report template Select the report template Example of dissolution test report
Report templates can be created by loading
sample data.

Client Client LabSolutions
Server

Acquisition Controller Acquisition Controller
(ACQ) (ACQ)

After analysis
The reports can be automatically
printed and the PDF files can be
automatically generated. LC GC LC LC FT-IR UV Balances

8 9