WHAT IS DATA LOGGING AND
WHY IS IT SO IMPORTANT?
Critical Product Storage and the importance of a compliant Data Logging System
A Pharmaceutical customer with an existing wireless logging system for monitoring product storage in Fridges, Freezers and Incubators in multiple Labs across the site.
Data loss due to GSM signal drops was causing concern around product storage control and compliance. A more robust system was required.
Having reviewed the existing system and infrastructure across the multiple Labs, IPP provided a very robust turnkey EMS system comprising of wired Temperature and Humidity sensors, five Yokogawa GM10 recorders and centralised Mirrhia EMS Software.
A GM10 mounted in a stainless enclosure was supplied for each Laboratory with temperature and humidity sensors installed at the designated Fridges or Freezers.
Real time data from each of the GM10 recorders was fed over ethernet (Modbus TCP) to the server based Mirrhia EMS Software.
All data trending, audit trails and alarm management are managed from the centralised Mirrhia software with access limited to defined users.
The EMS system is extremely reliable and full compliant to 21CFR Part 11 and current Data Integrity guidelines.
Built in redundancy in the form of qualified Yokogawa GM10 recorders storing data locally and to a central server in the event of any temporary loss of access to the Mirrhia data.
User defined access levels with full integration with site Active Directory servers.
Site wide overview graphics outlining each Lab and sensor location providing ease of identification of alarms.
Comprehensive Vendor IOQ Documentation Packs for both Yokogawa GM10 & Mirrhia software providing fast qualification.
The end result was successfully commissioned site-wide EMS system for the Laboratories providing a clean User friendly interface for data trending, alarm management and audit trail access.