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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.

2.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.

2.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