Cold Chain Drug Product
Set-Up and Initialization
Sequence works with our clients to customize a monitoring program based upon the intended use, cost effectiveness, and level of compliance risk desired by the client.
Set-Up and Initialization:
- A client questionnaire will be completed before Sequence can provide a holistic remote monitoring solution. The client questionnaire will establish the following attributes:
- Acceptable operating range(s)
- Alert alarm limits (if applicable)
- Critical alarm values
- Amount of time a temperature can be out of range
- Response time
- Monitoring timeframe
- Reporting attributes
- Trending attributes
- Following the completion of the client questionnaire, a risk- / cost-based approach will be taken while selecting a monitoring hardware and software platform service provider that meets our clients’ needs and intended usage.
- Installation, Operational, and Performance Qualifications (IOPQs) which can be performed to determine necessary boundaries on a manufactured lot of refrigerators for cold chain drug product delivery at sales reps homes or distribution hubs.
- Installation and Operational Verifications (IOVs) at each professional sales representative’s home or distribution hub for the entire lot of Cold Chain refrigerators.
- Initial On-site Calibrations of both the controlling internal probe and the Monitoring Platform’s probe:
- Can be completed by a Sequence technician at the location of the refrigerator or
- A calibration kit can be sent and the calibration performed by the unit owner with remote guidance from a Sequence technician.
Note: Sequence provides remote monitoring services for any installed monitoring hardware and software on the market. However, if you are in need of a new or upgraded hardware and/or software monitoring solution, we have formed several strategic partnerships with selected vendors. These partnerships allow us to provide our clients with a value-added start-up and initialization enabling Sequence to provide a complete package of Quality Monitoring Services.
Continuous Monitoring Capabilities
The Sequence Monitoring Center provides customized data analysis and reporting to turn raw data into regulatory-compliant records. The data transmitted to our Monitoring Center is constantly assessed for alarms or underlying identifiers that could adversely impact your product or controlled environment. Early detection of an adverse trend can make the difference in avoiding potential product loss, saving you valuable time and money. At the first sign of trouble, a trained Monitoring Center Technician notifies you of the situation, immediately initiating the investigation process.
Continuous Monitoring Capabilities:
Sequence will tailor alarm reporting and trending reports to ensure our clients receive all necessary information to achieve project demands. Customizable options include:
- Monitoring of Alarms
- Out of Specification (OOS) documentation created for critical alarms as they occur
- Both the client designee and unit owner are notified of a critical alarm based on the timeframe required by the client
- Work with the client representative to find cause and solution
- Troubleshoot with unit owner, if needed
- Provide training to client staff in order to reduce future alarms
- Closure of Out-of-Specification documentation with Quality Assurance oversight and signature
- Monitoring Updates
- Summary of Critical Alarm notification(s) sent to client Daily/Weekly/Monthly
- Continuous communication with Client to ensure alarms are acknowledged and the issue has been resolved
- Annual or 6-month Calibrations to ensure optimal unit functionality
- Can be completed by a Sequence technician at the unit’s location
- A calibration kit can be sent and the calibration performed by the unit owner-with remote guidance from a Sequence technician
- N.I.S.T. traceable As-Found and As-Left calibration results provided
- Out-of-Tolerance documentation created if As-Found results do not meet client-specified acceptance criteria
Monitoring Center Technicians will work with you throughout the entire investigation process to determine the scope of the alarm and evaluate the impact to the product or samples. Sequence Quality Assurance will review all data to ensure data integrity, accurately represented results, and guidance through the closure of critical alarm remediation.
Sequence Quality Assurance offers the following regulatory-compliant measures:
- Quality Assurance signature on all OOS, OOC, OOT and calibration documentation
- Monthly/Quarterly/Annual trending reports
- Trending of all critical alarms with Max, Min, Avg. values over the course of the trending timeframe based on an individual basis or the cold chain fleet deployed in the field
- Suggested improvements to the cold chain process to minimize alarm frequencies
- Summarizing critical alarms
- Quantity of alarms
- Types of alarms (Low Threshold, High Threshold, Disconnects, etc.)
- Causes of alarms, based on investigations and OOS documentation (open doors, power failures, internet failures, improper training, etc.)
- Product Loss Investigations
- Client is notified immediately. The level of documentation [including product discard] will be determined.
- Investigation is performed through conclusion. The level of documentation involvement will be determined at contract negotiation phase. Sequence can even track and maintain product discard within the product loss investigations.
- Record-keeping of online scanned PDFs & original hard copy records for each monitoring point
- Asset Birth Certificate – serial numbers, associated hardware, operating range(s) calibration frequency, etc.
- IOPQs / IOVs
- Calibration documentation
- Out-of-Specification critical alarm documentation
- Out-of-Calibration documentation
- Product Loss investigations