User Interface


Data Presentation Format

The user interface must allow the display of environmental parameters both in real-time and from archived data. The data presentation format should enable accurate determination of parameters, including the exact moment when they occurred. Measurement locations or points must be clearly labeled with unique identifiers, and units of measurement should be explicitly displayed. Additionally, necessary contextual information for proper interpretation of the presented parameter values (real-time data, archived data, maximums/minimums/averages, etc.) must also be shown.

Typical real-time environmental data presentation formats for environmental parameters include:

  • List (Table) format
  • Layout View (parameter values displayed on a layout)
  • Graphical Representation (curves showing parameter changes over a short recent time period)

Typical archived environmental data presentation formats include:

  • List (Table) format
  • Graphical Representation (trends)

Reports

GMP monitoring systems should allow for the generation and printing of reports. These reports must contain all necessary information in accordance with GMP requirements:

  • Document title / identification of parameters and time period presented
  • User who generated the report
  • Date / time
  • Page number / total pages
  • Field for signature (printed reports should be signed in paper form) or an electronic signature.

Reports can be presented in both graphical and textual (table) formats. Reports saved electronically must be in a non-editable format (e.g., PDF).


Data Export

GMP monitoring systems should allow data export for subsequent analysis and statistical processing. Since exported data is meant for processing, it is exported in an open, editable format (e.g., CSV) and does not require protection (GMP reports serve as the protected documents). The optimal location-neutral field separator for exporting data in CSV format, enabling correct opening in MS Excel, is the semicolon (";").


Tarqvara GMP Monitoring System

The Tarqvara GMP monitoring system implements all the aforementioned user interface functionalities, including report generation and data export features.

See also:
GMP Monitoring Systems
Tarqvara GMP Monitoring System
Audit Trail
IT Solutions / GAMP / Data Integrity (RDI)
Computerized Systems Validation (CSV)