Shimadzu Total Solution for PIC/S and FDA Compliance

Network System to Regulatory Compliance

Multi Data Report solves the Excel problems.

1. Audit trail problems
・Difficult to identify the creator, date and time of registered data
・Impossible to know who changed values or formula and when

2. Data security and integrity problems
・No means to prevent overwriting or deleting files

3. Electronic signature problems
・No electronic signature functions available

Features of Multi Data Reports

Simple system creation
Easily create report templates as flexible as Excel sheets by visual operation. Created templates are easily registered to the database for secure management using the registration tool. This reduces the workload before operation of the system.

Easier report generation
Generate reports automatically by simply selecting analysis data and report templates registered in the database.
In addition, reports are created simultaneously when an analysis ends using the analysis schedule. No manual input is required, saving effort for report generation and checking. Verified templates for system suitability tests, content uniformity tests, and other standard tests are provided as standard.

Automatic generation of PDF files
A PDF file is generated automatically at the same time a report file is created. The excellent portability of PDF files is effective for electronic report transfer.

Automatic database registration
Created reports are automatically saved in the database for secure storage. Required reports and analysis data can be easily found and recalled using the associated information that is automatically registered simultaneously.

Electronic signature-compatible
Electronic signatures can be applied to reports using standard functions of LabSolutions Data Manager.

Automatic Report Generation by Batch Analysis

Multi Data Report Meets All Regulatory Requirements

"Multi Data Report" registers pre-created templates to a database. When a report is generated, it automatically selects the template, pulls required data from the database and conducts the calculations. Through this procedure, only templates and data already in the database are used for calculations.
The report that calculated the results is also saved and managed in the database. Consequently, the user does not directly touch the data, thereby maintaining the access control, audit trail, and protection and security of data.

Access control Templates are saved in a secure database.
Audit trail Database records secure audit trail.
Possible to apply electronic signatures on reports.
Protection and security of data Data in database cannot be changed.
Validation No macros are required, only sheet functions are used, making validation simple.
Validated templates are controlled in a database.
PDF report Reports are automatically created as PDF files.
Easy to use Transcription of data is not required.
This eliminates the time needed to re-check data to prevent errors in transcription.

Basic Points on Excel validation

 

  • GAMP classified Excel as "Category 3" - No individual validation of the package required.
  • Validation of formula is required, despite being classified as "category 3".
  • 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.

 

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 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.

For Research Use Only. Not for use in diagnostic procedures.

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