CFR Part 11 Compliant Temperature Monitoring Solution

CFR Part 11 Compliant Environmental Monitoring

Meets the regulatory requirement or recommendation

Exceeds the regulatory requirement or recommendation

Compliance Matrix		FDA (GxP, cGMP, and GLP)	FDA (CFR 21 Part 11)	FDA (HCT/Ps, CGTP)	JCAHO	VFC	AABB
Alerting and Notification	Completely automated alerting
	24 x 7 alerting always on, always ready
	Notifications via email, SMS text, and/or phone
	User alerts
	Algorithm for elimination of false positives
	Twice daily check-in ("Documented Eyes")	n/a	n/a	n/a	n/a		n/a
Monitoring	Continuous at user or agency defined sampling rate
	Redundant backup systems
	User access on any internet-connected device
Control of Process	Temperature
	Humidity
	Light					n/a	n/a
	Pressure differential					n/a
	Voltage
	Network connection
	Backup systems status
Reports	Health agency audit-ready reports and charts
	Administrative reports (alerting, response times)
	Fully auditable database with corrective action reporting
Records	Retrievable from any secure internet-connected device
	Downloadable and printable in a secure, audit-ready format
	User defined 2+ year retention periods
Software	Web accessible closed system
	New versions validated by qualified and authorized personnel
	Banking level encryption
Hardware	Unique MAC addresses for devices
	Unique ID information displayed on devices
	Qualified via an IQ/OQ/PQ process supported by SOP's
Calibration	NIST-Traceable
	Retrievable calibration records
	Calibration status displayed on device placard
Security and Data Protection	Encrypted web access
	Encrypted data storage
	System documentation controlled via use of a secure EDMS supported by proprietary SOP's
	Defined access levels with associated permissions