Tech_Requirements.doc

TECHNICAL REQUIREMENTS

· Comprehensive temperature and humidity monitoring system must meet all requirements consistent with the ISO/IEC 17043 standard to monitor and record temperature and humidity readings from the following areas in the CDC Newborn Screening Laboratories:

· 10 liquid nitrogen tanks

· 78 freezers -85°C to -5°C

· 42 fridges 0°C to 17°C

· 8 incubators 35°C to 38°C (with CO2 measurement)

· 4 ovens 30°C to 200°C

· 8 open laboratory areas

· Instalation qualification (IQ), operational qualification (OQ), and performance qualification (PQ) documentation must be consistent with ISO/IEC 17043 requirements.

· Installed system must include ISO 17025 accredited calibration of the sensors (NIST traceable calibration)

· NIST traceable sensors must be used to monitor temperature (available in range -200 °C to +250 °C), Humidity, CO2, O2

· Minimum of 0.1 °C resolution

· System must have capability for out-of-specification reporting with the ability to electronically review and/or approve reports

· System must be able to document corrections/corrective action with electronic signature

· Transmitter battery-life of at least 12 months, based on minimum two readings per hour

· Door status sensor and 2 analog inputs on each transmitter

· LCD temp/humidity display on transmitter modules

· Audible and visual alarms on transmitters

· Minimum 14 days data buffering on transmitters when power or connection to server fails

· Single-server 21 CFR part 11/CLIA/ISO compliant system scalable to 1000 inputs and up to 64 users

· Server and SQL instance that supports virtualization using VMWare ESX Hypervisor

· Active Directory or LDAP Domain Authentication

· Ability to create user groups and at least 3 permission levels

· Text/email alerts

· Secure logs of all system activity, recording user and action with date/time

· Self-healing MESH network that auto-recovers from receiver failures

· User-friendly web-based client GUI (no client application required)

· Table, List and Map views of monitored resources