Moni.NET ClassC

Moninet Software Uebersicht

 

Mobile particle monitoring system of cleanroom classes B, C and D according to EU-GMP guidelines

Nr. ES Moni.NET ClassC

  • software package for efficient realization of mobile particle measurements
  • compatible with particle counters from different manufacturers
  • storage of measured values in tamper-proof databases
  • extensive report selection
  • highly automated evaluation according to current guidelines of cleanroom technology
  • integrated user management with audit trail function
  • high economic benefit along with quality improvement

 

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Mobile particle monitoring system of cleanroom classes B, C and D according to EU-GMP guidelines Annex 1

 

Moni. NET ClassC considerably reduces the ongoing administrative tasks. The recorded measurement data is automatically imported from the particle counters (online directly during measurement or offline) and stored in a tamper-proof database. Previously required steps such as manual filling, gluing, signing, copying, transferring measured values and compiling statistics are no longer necessary.

 

Depending on the cleanroom class, the measurement parameters can easily be edited for each measuring location and measuring head. Particle counters are automatically configured when measuring with Moni. NET ClassC (sampling volume, number of measuring cycles), a parameterization of the particle counters is no longer necessary. Measurements are carried out conveniently and economically and can be started at the push of a button.

 

The minimum duration of measurement or the required sampling volume in accordance with ISO 14644-1 are determined automatically; if this is not reached, measurement cannot be started; alternatively the user can also configure longer measurement durations.

 

All measurement reports are generated automatically. Measured values can be displayed very easily and in various ways in the form of reports. Simply select the desired node in the tree view by mouse and select the required report (diagram for long-term trending, measurement protocol,...).

 

  • icon Key features
  • icon Applicable documents and regulations
  • icon Downloads
  • simple and self-explanatory user guidance
  • clear tree structure of master data and measured values
  • high economic benefit and quality improvement
    • considerably less administrative effort
    • minimization of manual work
    • high quality and flexibility at the same time
  • reading of measured values directly online during measurement or offline by reading out the measured value buffers from the particle counters and automatic allocation to the measurement location
  • storage in tamper-proof database
  • extensive selection of reports:
    • diagram display (historical trending)
    • clear measuring protocol
    • to-do list (calendar function: time of the next measurement for each measurement location)
    • plant structure
    • audit trail (CFR 21 Part 11: record changes are logged and can only be performed by authorized users and after entering a reason for change)
  • multi-user operation (integrated user administration)
  • network compatible
  • can be used on standard PCs under Windows 7 or Windows 10
  • easy installation and integration into existing IT infrastructure
  • all reports can be provided with an individual header with your company logo within the scope of licensing
  • license validity: any number of measuring points and users at one production site
  • free trial version available
  • the entire project from one source: consulting, planning, execution, service, commissioning, qualification and training
  • even after commissioning, your personal contact person will be at your side for maintenance, qualification and training
  • you can also reach your contact person at any time via telephone, mail and TeamViewer
  • developed in Germany
  • Discontinuous particle monitoring of cleanroom classes B, C and D according to
    • EU-GMP-Guideline Annex 1 and
    • ISO 14644:2015
  • Regulatory compliance with the requirements for computer systems according to
    • EU-GMP-Guideline Annex 11
  • GMP qualified software
    • Validated software according to GAMP5® category 3 (only IQ, no OQ)
    • Development in accordance with GAMP5® category 5
  • integrated user administration with audit trail function (CFR 21 Part 11)

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