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Overview of PDF Reports in RMS

All PDF reports created in RMS are created in the format PDF/A (ISO19005-1).

All reports can be validated under the validate report function within the events tab. The validation will test to see if the report has been edited (Please see print screen 7: Events Explained).

Audit Trail Report:

The audit trail report is configured under the report templates (Tools>Setup>Report Templates Explained). Multiple templates can be created.

Deviation Report:

The deviation report is a standard report and cannot be configured. The deviation report can be created from the audit trail (warning and alarm events) (Please see print screen 2: Events Explained).

The deviation report contains the following details:

  • Report Details.
  • Measuring Point Details.
  • Event Details (including all user comments).
  • Measured Values Details (during the time of the deviation).
  • Limit Violation Details (during the time of the deviation).
  • Chart (including the deviation).
  • Related Events (during the time of the deviation for the measuring point, device and system).

Data Analysis Reports:

  1. PDF Report:

The PDF data analysis report is configured under the report templates (Tools>Setup>Report Templates Explained). Multiple templates can be created.

  1. Batch Release/Certification Report:

The batch release/certification report is a standard report (designed based upon the EudraLex Volume 4 Good Manufacturing Practice, Medicinal Products for Human and Veterinary Use Annex 11: Computerised systems, chapters 8 and 15 and the GAMP 5, A Risk-Based Approach to Compliant GxP Computerized Systems, Second Edition, Appendix S2 – Electronic Production RecordsVolume) and cannot be configured (Please see print screen 7: Tools>Data Analysis Explained).

The batch release/certification report can be created from the data analysis menu. The batch release/certification contains the following details:

  • Report Details.
  • Batch Release/Certification Date Details.
  • Batch Information Details.
  • Batch Release/Certification Overview Details (including an automatic release/certification status).
  • Conclusion Details (including an automatic release/certification status for each measuring point).
  • Data Overview Details.
  • Chart Details.
  • Comments
  • Signature Details.

Calibration Report:

The calibration report is a standard report and cannot be configured. The calibration report can be created from the calibration menu (Tools>Calibrate Explained).

The calibration report contains the following details:

  • Report Details.
  • Measuring Point Details.
  • Summary: As Found Details (include calibration number, time and date, reference, UUT, error and result).
  • Summary: As Left Details (include calibration number, time and date, reference, UUT, error and result).
  • Each Calibration Event in Detail.

Validation Report:

The validation report is a standard report and cannot be configured. The validation report can be created from the validation menu ( Tools>Validation Explained).

The validation report contains the following details:

  • Report Details.
  • Validation Test Details per Measuring Point.

Mapping Reports:

  1. Area Characterization Report.

The area characterization report is a standard report (designed based upon the USP1079 Good storage and distribution practices for drug products and the WHO supplement 8 Temperature mapping of storage areas) and cannot be configured. The area characterization report can be created from the mapping menu (Area Characterization).

The area characterization report contains the following details:

  • Report Details.
  • Qualification Date Details.
  • Project Details.
  • Area Characterization Details.
  • Characterization Overview Details.
  • Conclusion Details (including automatic recognition of hot/clod points).
  • Measuring Point Overview Details.
  • Data Overview Details.
  • Deviation Overview Details.
  • Chart Overview.
  • Recommendations.
  • Comments.

  • Signature Details.

  • Device Characterization Report

The device characterization report is a standard report (designed based upon the DIN12880 and NF X 15-140 requirements) and cannot be configured. The device characterization report can be created from the mapping menu (Device Characterization).

The device characterization report contains the following details:

  • Report Details.
  • Qualification Date Details.
  • Project Details.
  • Equipment Characterization Details.
  • Characterization Overview Details.
  • Conclusion Details (including automatic recognition of conformity).
  • Measuring Point Overview Details.
  • Position Overview.
  • Chart Overview.
  • Summary of Results Details.
  • Statistic Details.
  • Recuperation time after Door Opening Details.
  • Comments.
  • Signature Details.

Service Report:

The service report is a standard report and cannot be configured. The service report can be created from the device menu (Tools>Setup>Device>Options). The service report contains the following details:

  • Report Details.
  • Overview Details (including all devices and measuring points selected).
  • Device Specific Service Event Overview (including next service data and all measuring point service events).

CCreated: 05.12.2024