ENDE
With the ‘FL-EMS flex’ GMP monitoring system, RETEL provides a next-generation, scalable system, which can be perfectly aligned to the customer’s needs.
GMP recording of room data (temperature, humidity, pressure, particles, air velocities, etc.) as well as signalling in production areas by means of audio and visual signal units.
Record your production and utility systems for GMP-compliant data acquisition on the FL-EMS flex. It can be integrated via all common interfaces to give you an overview of your facility.
Recording of temperature control units such as refrigerators, freezers, cold rooms, incubators, etc, which can be connected directly or via separate sensors. Mapping can also be carried out upstream for the precise placement of the sensors.
Depending on your storage requirements and storage areas, we support you in defining whether temperature and humidity need to be monitored and work with you to determine the positions and number of sensors. With the right technology, we measure your storage area cost-effectively and efficiently.
Intuitive, simple operation, comprehensive overview of GMP-relevant production parameters and seamless data thanks to intelligent functions and analysis options.
Measurements are updated and stored in real time. Data that has been recorded can be accessed by means of a graphical floor plan or tabular representation. Where limits are exceeded, this is highlighted in colour for the measuring points concerned.
For each value measured, parameters can be set for any number of limit controls (alarms and warnings). The system has alarm lists detailing all active exceeded limits waiting to be acknowledged, along with historical alarms.
The measurements can be displayed individually or as predefined groups in the interactive trend module. The user can access various functions such as zoom, marker, free text caption, export, etc. to facilitate an optimal evaluation outcome.
GMP-compliant data acquisition for rooms/processes/facilities
Compliant with FDA 21 CFR Part 11/EU Annex 11 and data integrity
Simple and intuitive to use
Complete integration of the solution into the customer’s system landscape
Data exchange with higher-level systems (ERP, MES, data historian, etc.)
Lower investment costs (hardware, engineering, installation costs)
Faster project implementation
Investment security due to standard hardware components and the latest technology
Expandability – the system can be expanded at any time, e.g. additional measuring points/sensors, display clients
Table display: current values and status
Display of the current values in tabular form depending on the grouping requested by the customer.
from V1.1
Table display: groups
Groups are displayed hierarchically in a table, showing their current operating mode and an overview of upcoming events.
from V1.1
Measuring point details displayed in multiview
new
All relevant information about a measuring point incl. graphical trend and event/alarm list are displayed in a form.
from V1.3
Assignment of display values and colours
For measuring points, there is the option of configuring the display values with colour.
from V1.2
Audit trail manual entries
The user can create manual audit trail entries.
from V1.1
Display time zone
In all views in which a timestamp is shown, the time zone of the timestamp is always displayed.
from V1.2
Switching the status of groups/measuring points
The user can switch measuring points and groups between normal and maintenance operation, thereby deactivating the assigned events/alarms.
from V1.1
Floor plan/data view in the desired level of detail
optional
Measurements are displayed in the view desired by the customer: floor views, department views or even room views
from V1.1
Navigation using overview images
optional
The user can navigate withinthe system by clicking on the desired area in site, building, floor and room views
from V1.1
Multilingual/language switching
optional
The entire system is multilingual and based on the language of the browser or the language profile of the user. Its configuration (e.g. message texts or descriptions) is still in one language (German or English)
from V1.3
Online event list
View of current upcoming events (alarms and warnings) with a variety of filter functions
from V1.1
Event acknowledgement
Event acknowledgement function with the option to select predefined text from a drop-down list for cause, evaluation and action. The predefined texts can be adapted and supplemented by the customer at runtime with the appropriate permission. The user can also enter free text when acknowledging them.
from V1.1
Multiple acknowledgement
It is possible to select several events/alarms in a single acknowledgement procedure.
from V1.1
Event counter for multiple occurrences
Multiple alarms are displayed hierarchically in the online event list with the number of pending events.
from V1.1
Historical event list
Display of historical events (alarms, warnings, system alarms, etc.) with a variety of filter functions
from V1.1
Manually created events
The system enables the operator to generate additional manual events, e.g. power failure of unit X.
from V1.1
Dynamic grouping of measurements and events
optional
Measurements and events can be grouped hierarchically in a schema defined by the customer. This allows departments to be put into maintenance mode, for example.
from V1.1
Multi-level event/alarm evaluation workflow
optional
Multi-stage evaluation process for defined event/alarm groups. This enables critical events to be processed completely within the system and documented in a GMP-compliant way.
from V1.2
Remote alarms
optional
Forwarding of events to various remote alarm systems via email. The configuration can be set up at runtime via the interface.
from V1.1
Graphical data presentation as interactive trend
View of sensor data in predefined trend groups or in a dynamically selectable form.
from V1.1
Time range selection
Predefined time ranges (e.g. 1 hour, 1 day, etc.) allow the operator to quickly access trend data in the desired time range.
from V1.2
Display of limits
It is possible to show/hide the limits for the measuring points displayed.
from V1.1
Automatic updating
Automatic updating of the graphical trend.
from V1.1
Move chart
The trend chart can be moved easily with the mouse cursor.
from V1.1
Freehand zoom
Freehand zoom functionality in the trend chart
from V1.1
Enlarge/shrink
Enlarge/shrink
from V1.1
Automatic scaling
Automatic scaling
from V1.1
Data marker
Any number of data markers can be created, which can be moved along the timeline by the operator.
from V1.1
Export/save chart (pdf, csv, jpeg)
Option to export the trend chart currently displayed
from V1.1
Print function
Option to print the trend chart currently displayed
from V1.1
Show/hide measuring points
Display stored measurements in the trend chart.
from V1.1
Free text caption
Option to comment on content of the trend chart
from V1.3
Event presentation
Option to display corresponding events/alarms in the trend chart
from V1.3
Sensor data (user-defined)
Display of selectable measuring points as a trend or table, including limits configured and events that have occurred, with various filter options.
from V1.1
Sensor data (groups)
Display of all measuring points of a group, including limits configured and events that have occurred, with various filter options.
from V1.1
Sensor data (trend groups)
Representation of the trend groups defined in the DPL as a trend or tabular report.
from V1.1
Statistics
Tabular presentation including statistical values such as mean, minimum, maximum, mean kinetic temperature (MKT) with various filter options.
from V1.1
Event reports
Tabular presentation, as a log or statistical evaluation with various filter options.
from V1.1
Audit trail report
Tabular presentation of the audit trail with various filter options.
from V1.1
Configuration reports
Display of all configurations of the FL system with various filter options.
from V1.1
Configuration check
Configuration reports can be generated either as PDFs or as Excel files. The Excel spreadsheet generated can be used for semi-automatic qualification of the configuration. The PDF can still be used for documentation.
from V1.1
Diagnosis report
Display of various pieces of diagnostic data for the analysis of errors with various filter options.
from V1.1
Automatically generated reports
Reports can be generated automatically based on defined criteria.
from V1.1
CSV/MS Excel data export
Data can be exported as a CSV/Excel file
from V1.1
Advanced analytics/Power BI
optional
The system can be connected to MS Power BI.
from V1.3
Self-monitoring
Detectable errors in the application generate alerts.
from V1.1
Overview of system status
The status overview visualises the status of all components relevant to the operation of the FL EMS.
from V1.1
Overview of maintenance operation
The maintenance overview visualises which groups and measuring points are currently in maintenance operation.
from V1.1
Status overview of all outputs
The current state of all digital outputs is visualised in tabular form. The current controlled state of the DOT is shown as superordinate and the respective assignments that lead to this status are subordinate.
from V1.1
Digital sets for data points
Text can be stored for enumerating status data points (e.g. 0=pause/1=start)
from V1.1
Configuration of measuring points
Measuring points can be configured at runtime.
from V1.2
Configuration of events/alarms
Any measuring point event (alarms, warnings, etc.) can be configured at runtime.
from V1.1
Configuration of measuring point groups
Measuring point groups can be configured at runtime.
from V1.1
Configuration of operating modes
Operating modes can be configured at runtime.
from V1.1
Configuration of text templates
Predefined texts for acknowledging events can be configured at runtime.
from V1.1
Confirmation of configuration adjustments
In the event of changes to the system, the user is asked to confirm their login and comment on the change.
from V1.1
User management
Strong user management for selective assignment of rights. The following user groups are available by default: – guest – operator – supervisor – administrator – manufacturer
from V1.1
Audit trail
The system has a secure, computer-generated and timestamped audit trail to ensure that operator input and actions that generate electronic records cannot be altered or deleted.
from V1.1
System backup
Since data and configuration are stored in databases, they can be backed up on the customer’s backup system on a daily basis, for example
from V1.1
Active Directory
The FL-EMS can be connected to the customer’s Active Directory for central user management
from V1.1
Data archiving
optional
Data is moved to annual archives after a configurable period of time. This data can then continue to be viewed, for example, for five years until it is finally disconnected and archived.
from V1.1
Terminals/clients
Terminals installed in production for the operation/monitoring of the system.
from V1.1
Multipoint adjustment
Multipoint adjustment of measuring signal with partial linearisation of up to 5 vertices
from V1.1
OPC DA client interface
Connection of external data sources via OPC DA.
from V1.1
OPC UA client interface
Connection of external data sources via OPC UA.
from V1.1
MS SQL interface
Controlled access to EMS data is possible via ‘Views’ and ‘Stored procedures’.
from V1.1
Digital/analogue inputs
Connection of analogue and digital signals via FL-PLC
from V1.1
AVEVA PI interface
Standard interface to AVEVA PI so that the data can be read via PI-RDBMS.
from V1.1
Standard communication protocols
Connection of external data sources via standard protocols such as Modbus TCP at PLC level.
from V1.1
Particle counter
Particle measurement with activation via visualisation or HW contacts.
from V1.1
PoE logger
Data acquisition by Rotronic RMS PoE logger with integrated data buffer and battery emergency operation directly from the control level (no PLC required).
from V1.1
PLC for data acquisition
PLC for connecting sensors and actuators with intermediate data storage and event evaluation at PLC level.
from V1.1
Template data point list
optional
FL-EMS standard data point list available as a template
from V1.1
Template equipment list
optional
FL-EMS standard equipment list available as a template
from V1.1
CSV toolkit for qualification
optional
RETEL offers a qualification toolkit (templates) for qualifying the FL-EMS.
from V1.1
HMI editor at runtime
optional
Floor plans can be configured via the web interface.
from V1.1
We can supplement your project with the following services if required:
We plan the recording of your GMP data and perfectly complement your project team during all planning phases.
Every room, storage unit or appliance (e.g. refrigerators and freezers) in which a controlled temperature must be maintained should be mapped and documented. We would be pleased to assist you with this.
Standardised CSV design and qualification documents ensure an efficient GMP-compliant CSV process. We would be happy to provide you with our documents.
We offer tailor-made training for your key users – even as part of after-sales support.
We support you with planned and unplanned maintenance. Tailored service level agreements make it easier for you to manage and maintain the systems.
We calibrate your measuring points (temperature, humidity, pressure, air velocities, etc.) with testing equipment certified according to SCS/DKD and ensure the GMP-compliant operation of your monitoring system.
We connect your existing alarm server to the GMP monitoring system or supply an alarm server solution to create transparency in your reporting system.
