CFR Part 11 Compliant Wireless Cold Storage Monitoring

Matrix Key:

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 State Board of Pharmacy

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