By managing data electronically, SPECTra significantly improves workflow efficiency in the following areas;
- Customer orders with consolidated invoicing information.
- Pre-production checks and worksheets.
- Direct capture from equipment, thus eliminating transcription errors.
- Dose Requirements; storing site, customer and dose information in one manageable place.
- Barcode driven inventory management, providing you with up to date stock levels and allowing use of accepted raw material only.
- Quality Management System; SOP, CAPA, Deviation, Change Control, OOS and Trending.
- Instrument Maintenance / Calibration; ensuring equipment is maintained in accordance with your SOPs.
- Labels and shipping documents.
- Notifications for efficient communications and reminders of any tasks.
- Training / User Records.
- Audit Trail.
- Sub-batches / Drug Stability Testing.
- Security Access in accordance with regulatory requirements.
- Electronic signatures; no more missing manual signatures.
SPECTra is a closed system that ensures compliance with regulatory demands.
User access is managed via a unique login ID that is linked to users’ training and skill set. Electronic signatures and audit trails are configurable and in line with the FDA 21 CFR part 11 requirements in sections 11.50 and 11.10, respectively. These functionalities ensure that you don’t miss signatures where required and that retrieving audit trails for review is the effort of a few mouse clicks.
LabLogic have decades of experience creating systems within highly regulated environments. We are confident that our systems will improve compliance within your facility.
Direct Data Capture
During the various phases of the workflow, facilities have to manage data from a range of equipment and software packages, resulting in multiple outputs and reports. What’s unique about SPECTra, is that it captures data directly from equipment used in the process.
Eliminates Transcription Errors
As a result of direct data capture, SPECTra completely eliminates manual transcription and the likelihood of any errors.
Interfaces to all Equipment
SPECTra captures data from all the equipment either directly or by interfacing to the respective software.
Multi-site facilities can standardise production of their radiopharmaceuticals with SPECTra. Each site can be configured to ensure the same processes are being routinely carried out, removing inconsistencies.
Implementing SPECTra enables LabLogic experts, alongside end user QA, to review and challenge current practices, building improvements and industry best practice into existing processes.
A modular system that improves workflow efficiency whilst ensuring regulatory compliance
SPECTra is a modular system which can be configured to suit the needs of any Radiopharmacy. It is designed to improve efficiency whilst maintaining regulatory compliance at all stages of the SPECT production workflow.
Both internal and external orders can be taken manually, with a full audit trail, or automatically via SPECTra’s On-line Ordering Module.
Customer information including delivery addresses, unique pricing details and customised product information can be stored in the customer explorer section to ensure efficient data management.
The Invoicing Module seamlessly integrates with customer orders so they are tracked automatically and can be generated in just a few mouse click’s.
SPECTra automatically calculates the required activity for a production session.
Worksheets are automatically generated to ensure your production session fulfils all orders efficiently.
The barcode driven Inventory Management Module ensures materials are available and are in date ahead of each production session.
SPECTra’s allows you to select the generators you want to elute for a particular session.
Activity measurements are captured directly from the Dose Calibrator and logged against server date/time.
Calibrator daily checks are recorded directly in SPECTra − results can be reviewed in the Trending Module.
Activity dilutions/vial split’s are calculated automatically – saving on operator time and avoiding errors in manual calculations.
SPECTra captures data directly from all QC instrumentation used within SPECT production, bringing it directly into the batch report.
As some QC tests are done manually SPECTra allows for manual data entry with a full audit trail.
For customers wanting to streamline control of their radiochromatography equipment, we have a dedicated single point of control software package called ‘Laura for PET.’
Individual patient doses will be automatically calculated in-line with each customer’s predefined criteria.
Direct data capture with Dose Calibrator and Balance ensure final product activity and volume are within an acceptable limit.
Product and transportation labels/documents are automatically generated and available for printing.
Throughout the whole production and QC process, SPECTra provides a simple and logical way of reviewing batch progress. This information is available to review from any workstation allowing technicians and quality personnel maximum visibility.
Once all the required tests have been completed successfully, the responsible person can electronically sign off the release.
All data is consolidated in a single, central repository. This can be printed to a user defined batch report.