It is important to weigh your options when choosing the right continuous monitoring system and we have a list of important questions for you to keep in mind:
Wired or Wireless
There isn’t a right or wrong answer. What will work best for you will depend on what you are monitoring and in what kind of space along with any other details that are important and unique to your needs. The wired sensors are somewhat more reliable because they are immune to interference and are easier to maintain than their wireless equivalent because no battery replacement is required. Even though the wired sensors are less expensive than wireless units, the overall cost to implement a system with them is usually higher due to the increased installation labor required. SmartScan offers both options and can even implement a combination of both. We will work with you to analyze your needs and help you make an informed decision that will best fit your facility, your monitoring needs and your budget.
The GMP version of the SmartScan system meets all the requirements set forth by the FDA in 21 CFR Part 11 as well as other Federal regulations along with USP , ISO 14644, and others throughout the world.
Good Distribution Practices (GDP) is a quality system for warehouse and distribution centers dedicated for medicines and medical devices. Internationally accepted GDP regulations stipulate that distributors of pharmaceutical and medical device products must align their operations with the standards. The scheme ensures that consistent quality management systems are in place throughout the entire supply chain, from the early delivery of raw materials to the manufacturing plants, to the final shipment of finished drugs to the end user.
All regulatory agencies, worldwide, require the use of accurate equipment to monitor the warehouse and other storage environments, whether the measurements are taken manually or automatically. All measurements must be recorded and maintained in a form where they cannot me altered, but are readily available for reporting. As the measurements are taken, they should be compared with alarm limits. If an abnormal condition is detected, the appropriate action must be taken to correct the problem. A record of these excursions must be maintained along with the necessary corrective action.
If you choose to implement a GMP compliant system, it must be formally validated. A number of Validation Templates (SDS, IQ, OQ, and PQ) are provided with SmartScan server software. You can use the templates to create your own validation documents or we can do it for you. We will also create an Installation Qualification (IQ) protocol document that contains sections for hardware and software installation verification as well as the fact that certain essential SOP’s exist. We will have filled in everything except the information required concerning the SOP’s. The Operational Qualification (OQ) protocol will be the one we execute on every release of the software and will be fully documented. With almost everyone, it is completely acceptable to use this document as the OQ for your system (and thereby eliminate a huge expense). The PQ document will be filled in after the system has been installed and commissioned. It will be used to verify:
1. That all sensors are being reported to the server and that they are named correctly. Use the Sensors Reports as objective evidence that all serial numbers, names, and groups are correct.
2. That the measurement data for all of the serial numbers is being stored in the database. Print a Measurement Data Report over a period just long enough so that the report contains all of the monitoring points. Use this report as objective evidence that all monitoring points are being logged.
3. That the alarms are being detected and alerts are being delivered properly. This will be done on a few selected inputs using the Validation Control Panel to trigger an alarm condition for each monitoring point. The setting on the control panel along with emails generated by this test plus the Alarm History Report will be used as objective evidence that alerts are being processed correctly.
We will work with your technician on-site to execute the PQ. Once this is completed, we will send the entire package to you to finish and present to the customer.
All of our SmartScan Monitoring Stations, Device Controllers, and Gateways have the built-in ability to store at least 12,000 (optionally 24,000, 50,000, or 100,000) 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.
CIMTechniques has been monitoring critical applications for twenty years. Here are just some of the important features we have integrated into our system thanks to customer feedback and years of experience.
-Completely web-based and accessible from anywhere
-Meets all Regulatory Agency Requirements (21 CFR 11, ISO 14644, USP 797, etc.)
-Can handle thousands of monitoring points & hundreds of users
-Remote monitoring wherever a LAN/Internet/Cellular connection exists
-Built around a secure SQL Database
-Organized by Departments containing Groups of monitoring points
-Alerts delivered via email, text message, pager and voice telephone
-Access under strict ID/password control
-All System Settings Changes recorded in an Audit Trail
-Accurate Hourly Statistics generated for every monitoring point
-Pricing model by number of monitoring points, not number of users
Contact us for more Information of pricing on your customized SmartScan Monitoring System today.