Facility Controlled Conditions

 

Stability, Laboratory, Manufacturing, Warehouse

 

Set-Up and Initialization

 

Sequence works with our clients to customize an individualized monitoring program by:

Determining specifications of alarms for each monitored unit/area:

  • Acceptable Operating Range(s)
  • Alert Alarm Limits
  • Critical Alarm Limits
  • Alarm Delays
  • Response Time
  • Criticality
  • Monitoring timeframe (24/7, 9-5 Mon-Fri., etc.)
  • Alarm Reporting Attributes Needed
  • Alarm Trending Attributes Required
  • Taking a risk-/cost-based approach on selecting a monitoring hardware and software platform that meets our clients’ needs and intended usage.
  • Performing Installation, Operational, and Performance Qualifications (IOPQs) on chambers and controlled areas to determine hot/cold spots prior to installing monitoring hardware.
  • Performing calibrations of both the controlling internal probe and the Monitoring Platform’s probe.

 

Continuous Monitoring Capabilities

In addition, 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 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 unit owner to find cause and solution
  • Troubleshoot with unit owner over the phone
  • If additional maintenance’s required, the unit provider or Monitoring Platform Owner is consulted, Sequence can troubleshoot and repair most issues in-house.
  • Provide training to client staff in order to reduce alarms

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

  • Completed by a Sequence technician
  • As-Found and As-Left results provided
  • Out-of-Tolerance documentation created if As-Found results do not meet client-specified acceptance criteria

 

Quality Oversight

Monitoring Center Technicians will work with you throughout the 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.

Quality Oversight:

Sequence Quality Assurance offers the following regulatory-compliant measures:

  • Quality Assurance signature on all OOS, OOC, OOT and calibration documentation
  • Monthly/quarterly trending reports available
  • Trending of alarms and Max, Min, Avg. values
  • Suggested process improvements to minimize alarm frequencies
  • Summarize critical alarms
  • Quantity of alarms
  • Types of alarms (Low Threshold, High Threshold, Disconnects, etc.)
  • Causes of alarms based on investigations and OOS documentation

Record Keeping of Online & Hard Copy Record for each monitoring point

  • Quantity of alarms
  • Validation documentation
  • Calibration documentation
  • Out of Specifications critical alarm documentation
  • Investigations and CAPAs