for CFR21 Pt.11 Compliance
Pharmaceutical product and storage facilities have to demonstrate compliance to the very high standards demanded by the Food & Drug Administration (FDA) as defined by CFR21 part 11.
This requires that companies keep detailed records of temperature and humidity for any facilities where drugs are processed and stored.
In a recent project for major European Distribution Centre – Hexatec upgraded the Environmental Monitoring System (EMS) to ensure compliance to the latest FDA standards and provide users with an easier to manage system.
Data Collection
The high accuracy temperature measurement system installed in the cold stores, freezers , warehouses and production areas was retain but new local data communication servers were installed to handle critical alarms locally and handle data from the high quality legacy systems and pass it to modern networked systems.
A hardware watchdog system ensures each of the data collection systems is working correctly and notifies staff immediately if any hardware problems are detected.
Secure Alarm System
In these critical systems it is essential that any environmental changes are quickly notified so that any problems with the control systems can be resolved before it can impact product safety. To ensure security of alarming, even if the networked servers fail, each warehouse outstation generates its own alarms and environment alerts. It also controls a local warning siren.
Alarms and alerts are displayed on screens in the warehouses and security office. Each event requires staff to acknowledgement and to enter an explanation. These user inputs become part of the systems secure event log and any QA reports.
The alarm settings, and instrument calibrations are managed centrally on a secure server located in the data centre. Any changes to these critical settings are controlled centrally and subject to strict controls and audits.
Distributed User Displays
On such a large site each department requires its own user display to monitor environmental conditions and handle any alerts or alarms. Outside of normal working hours responsibility passes to the security office. These displays use Hexatec’s SCAN1000 software.
Strict software version control on every display station is managed from a central server.
Data Storage and Web Reporting
Environmental data is stored centrally, together with the calibration settings and system event logs, on a dedicated server located in the companies secure data centre. The data is fully secured and the data flows fully validated to ensure that the information stored is auditable by the FDA.
In addition to storing detailed records for FDA compliance the system also provides facilities managers with detailed information for managing the facility control systems (BMS). These include:
· Temperature distribution reports for each store,
· Trends showing the performance of the control systems,
· Door open statistics,
· Alert and Event log summaries for selected periods
· Plant room data & energy use
For more detailed analysis, data can also be exported to Excel, or other application software.
This system uses a combination of Hexatec’s SCAN1000v5 (SCADA software) and Audit1000 data management and reporting software.
Contact Hexatec for further information.