Your Continuous Monitoring Questions Answered
When choosing a Continuous Monitoring System (CMS) it’s good to start asking questions to be sure that the system you choose will cover everything that is uniquely important to your needs. We want to help make that process easier for you and have provided some important questions to keep in mind.
1. Can the sensor and system meet your accuracy requirements?
SmartScan is a fully validated system with available validation documents. SRS, IQ, and PQ protocol templates are provided along with a fully executed and documented OQ. Complex systems can be completely validated in days, not weeks.
2. What are my regulatory requirements? And can this CMS keep me compliant?
The SmartScan system is fully GMP compliant and meet all of the monitoring data and integrity requirements set forth by worldwide government regulators (FDA, EMA, CFDA) as well as industry groups (USP, AABB, CAP) and accreditation agencies (Joint Commission and others)
3. Does the system have the ability to limit who has access?
One or more monitoring Groups (departments) can be created within SmartScan. Users can be given access to any or all of these groups. Whenever a user logs onto the system, they must supply a User ID and Password. The system uses the user ID to determine what to include on the Home page. If a user has access to multiple groups, the multi-group status page is displayed showing a list of all the monitoring points where an abnormal condition has been detected. In addition to the alarm list, the overall status (number of alarms, warnings, errors) for each group is displayed in a list. The user simply clicks on a hyperlink by one of the groups to open the group status page for that group.
4. Can the system monitor multiple sites and locations?
SmartScan can, it can be used to continuously monitor just a few sensors or thousands at one or more sites while allowing simultaneous access by hundreds of users. The system is scalable, flexible and completely customizable.
5. How will I be notified – email, phone call, text?
All of the Above! All or the preferred method as designated by the user. Alerts are generated by a sophisticated user-configurable system and delivered in the manner you choose.
6. How often are the sensors calibrated?
To maintain your system’s GMP and 21 CFR 11 compliance, you will need to verify the accuracy of our sensors at least once a year. SmartScan’s EZcal system provides a fresh approach that significantly reduces the time, effort and cost required to calibrate temperature and temp/humidity sensors in the field. The method is quick, straightforward, and accurate — simply replace the existing sensors with ones that has been fully calibrated. This is made possible because SmartScan’s digital CQ and CZ sensor probes all have built-in data acquisition units that produce digital values in engineering units (°C for example).
7. What reports are included? Are there custom reports?
Reports are completely customizable. Set up a standard report for all users or each user can customize their own report based on what’s relevant to them. They can be automatically generated and emailed, pre-scheduled or on demand.
8. What if there’s a Power Outage?
All Monitoring Stations, Device Controllers, and Gateways have the built-in ability to store at least 12,000 measurements if communication with the server is lost for any reason. Once the fault is cleared, the buffered measurements are automatically uploaded just as if nothing ever happened. During the outages, the remote stations handle local alarm processing using the limits sent down from the SmartScan server.
9 What service and support is offered for the system?
Through our System Admin Support Program we assume the role of our system administrator. Whenever a problem with the system is detected, we are automatically notified by email. One of our skilled technicians then logs on and determines the source of the problem. Software or configuration issues are corrected immediately. Hardware problems are corrected by component replacement with assistance from your maintenance staff.
10. Will this system save you time and money?
Yes. SmartScan is affordable and easy to use. It will save on labor costs by freeing up time for employees that would have to manually record data and create intricate reports. Save on inventory by alerting key personnel to issues before your assets are affected. Employees can be more efficient by focusing on their jobs. It will protect inventory and valuable critical assets.