O PharmaWatch™
1.888.234.5157
222 North 13th Street, Suite 200, Boise, ID 83702
info@ameri-pharma.com
222 North 13th Street, Suite 200, Boise, ID 83702
info@ameri-pharma.com
CFR Part 11 Compliant Environmental 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 |