DoseControl Software - Overview
DoseControl is a FDA 21 CFR Part 11/EU Annex 11 compliant electronic recordkeeping system that controls the dosimeter measurement workflow. The primary purpose of the system is to collect dosimeter measurement data and produce dosimetry reports.
Dosimetry Report Management
Dosimetry measurement information is contained in Dosimetry Reports; reports are managed through a versioning system.
Create New Report: Select “New Report” and choose from a drop-down menu of pre-configured report types.
Report Summary screen: Review overall report information, measurement results, any process results (min/max, measurements outside the range), comments, and more. Review before processing a report.
Process Report: Final report is complete; the user selects “Process Report” to save this version of the report (example: ReportName version 1). Process reports are shown in green in the Report List main screen.
Version Report: User can create versions of an existing report that has been processed (example: ReportName version 1 and ReportName version 2).
Details: How to create, use and export reports and How to search for a Report or Dosimeter ID
Dosimeter Measurement Workflow
DoseControl provides step-by-step management of the dosimetry workflow. The Technician users can measure dosimeters in the software, and the Application Administrator pre-configures all dosimetry process parameters, dosimeter report types and report headers.
DoseControl software controls spectrophotometer.
Specialized holders ensure consistent dosimeter placement.
Every measurement follows the same process.
Eliminates user error.
Details: How to measure dosimeters.
Dosimeter Rereads (re-measurements)
DoseControl provides a controlled process for handling dosimeter rereads (re-measurements). Each measurement is captured and recorded by the audit trail, so the measurement history is not lost (21 CFR part 11 requirement). This means the original measurement and all subsequent re-read measurements are permanently recorded by the software. A re-read measurement value is displayed in the dosimetry report; all measurements are recorded in the audit trail.
Details: How to Reread (re-measure) dosimeters and About Rereads
Audit Trail
The audit trail is separate from the dosimeter measurement and reporting areas of DoseControl. The Application Admin can access the audit trail.
Details: How to Use the Audit Trail.
Performance Verification of the Evolution spectrophotometer
Optional module available for DoseControl-Evolution dosimetry systems. The purpose of the Performance Verification (P.V.) Module is to provide a short-term verification or ‘daily check’ of the reader’s absorbance measurement accuracy.
Details: About the Performance Verification Module
Product Specification Module (optional)
Optional module available for all dosimetry systems. The Product Specification Module automates report creation and eliminates user input errors. User can simply select a product from a drop-down menu and the software will automatically fill in the dosimetry process specification information related to that product.
Details: About the Product Specification Module
DoseControl Software Outputs
Dosimetry Reports
DoseControl outputs secure PDF reports and Microsoft Excel reports. Customize these reports with customer and process information, or use a standard template for routine dosimetry, reference dose dosimetry, E-beam testing, dose mapping, and dosimeter batch calibrations. Details: Setup - Dosimetry Reports.
Audit Trail Reports
DoseControl software permanently records all events and creates an audit trail that is available to save or print as a secure PDF report. Within the software, the user can filter the audit trail as needed and create a report with the relevant historical events. The user can save and print audit reports. (See Audit Trail and Audit Reports section).
Performance Verification Reports (DoseControl-Evolution systems only)
Save and print performance verification summary reports for wavelength and photometric accuracy of the Evolution spectrophotometer.
Calibration Verification Reports
Save and print Calibration Function Output Verification reports for the dosimeter batch calibration verification functionality in DoseControl. Details: Setup Calibrations (Dosimeter Batch Calibration)
Export data to integrated system (Enterprise license)
Export any data from DoseControl, including any information recorded related to the dosimeter measurement, process parameters, product specific information, and more.