SPECTra

Radiopharmacy LIMS Software

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 Radiopharmacy LIMS, is that it captures data directly from all equipment used in the process.

Eliminates Transcription Errors
As a result of direct data capture, SPECTra Radiopharmacy LIMS completely eliminates manual transcription and the likelihood of any errors.

Interfaces to all Equipment
The state of the art radiopharmacy information management system captures data from all the equipment either directly or by interfacing to the respective software.

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 secure Radiopharmacy LIMS 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.

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.

Audit Trail

SPECTra  provides auditing facilities so that data can be checked and validated as described in FDA 21 CFR part 11 Section 11.10 paragraph (b).

Whenever a change is made to the data, SPECTra adds that change to the audit trail. The reason for any change is selected - the previous value, new value, operator and the date/time is recorded.

User Settings 

Quickly and simply configure a users settings for access, training and statistics.  

Access Levels

Hierarchical levels of access can be configured within SPECTra.

User Groups

User groups can be created so that relevant notifications are sent to appropriate users.

Training Records

Personal training records can be maintained within SPECTra and access rights within the system linked to their training and qualifications.

The quality management module in SPECTra, ensures every action is completed following predefined processes. Documentation is therefore easily and securely accessed throughout the LIMS and completely eliminates the need for a paper chase.

SOP

Provides an easy and intuitive way of managing SOPs.

Operators are able to view all the SOPs on-line and alongside the applicable section.

Reminders can be set so that the Responsible Person is notified of when an SOP is due for review, etc.

Document Management

The Document Management facility is an information portal for all types of documents, not just those subject to formal change control.

Providing the benefit of a closed and fully auditable system.

Out of Specification (OOS)

Provides electronic management of the investigation of a result outside the parameters.

The findings are maintained within SPECTra, can be reported at any time and are progressed to CAPA, if applicable.

Corrective and Preventive Action (CAPA)

This module is designed to solve problems quickly, minimise the impact of discrepancies and reduce the chance of re-occurrence.

CAPA process in SPECTra ensure corrections, cause analysis and preventative actions are all recorded effectively.

Deviations

Electronically manages any deviation from the established procedures using pre-defined forms.

Allows for efficient and consistent data capture along with immediate corrective action.

Change Control

Allows users to control changes to manufacturing processes.

Changes can be drafted, reviewed and accepted by authorised users.

Notifications

Notifications in SPECTra improve communication to users throughout the facility.

They can be sent directly to a user or group, automatically generated in relation to an event or scheduled in the system.

Notifications are very flexible and can be used for a variety of reasons including reminding people of certain tasks, communicating group messages and operational alerts.

Trending

Any function can be analysed over time. This may be to look for variations in instrument performance or any other parameter such as synthesis yields.

Automatically generate customer invoices, eliminating transcription errors and saving a considerable amount of time.

Invoice Data Management

Seamless integration with the ‘Customer Explorer’ and online ordering feature where unique prices and rules are allocated to each customer and their available products.

Quickly and simply generate consolidated invoicing data, which can be sent to the accounts department or directly onto the customer.

User Access Levels ensure only the relevant people have visibility of customer pricing details.

Online Ordering

Customers can place orders via the online ordering module using a predetermined product list, with customer specific pricing.

Orders are automatically integrated into SPECTra’s production worksheets. Giving real time updates on upcoming orders.

Eliminates the need for manually processing customer orders, removing transcription errors and further streamlining the process.

Information on each piece of equipment from which SPECTra captures data, is automatically registered within SPECTra. A range of tools are provided in order to help manage the instrumentation.

Instrument Maintenance

Stores and manages all instrument maintenance records.

Notifications can be set up to remind responsible people for regular checks.

Records for each piece of equipment can be fully maintained based upon a number of key parameters such as supplier, instrument name, instrument type etc.

The frequency may be defined as manual, week days, weekly, monthly, quarterly, annually or biannually and notifications set up accordingly.

Synthesis of any radiopharmaceutical generally requires multiple raw materials. This SPECTra module enables you to keep track of your entire inventory along with the respective QC data electronically.

Labels & Barcodes

Ensure compliance and traceability of each product, raw material.

The Label Designer can produce various labels including; Syringe, Final Product Vial, Lead Pig, Shipping Document and Inventory labels.

Each label can be customised to contain images and company logos.

SPECTra can be create, or use suppliers own barcodes, to simplify tracking.

Automatically track the components and generate barcodes for 'kits' of raw materials.

Stock Control

Provides full chain-of-custody management of all inventory.

Can deal with the ordering of items, receipt, quarantine, monitoring and prompting of expired items.

Items can be simply scanned into the batch using the barcode feature. Records are then automatically checked and updated to ensure complete traceability and compliance.

Powerful search/find functionality, for quick and easy access.

First in first out rules, ensure continuous stock rotation.

User defined re-order levels, help maintain a satisfactory level of stock.

Inventory overview section for easy monitoring of stock.

Radioactive Stock Control

Half life decay calculations in SPECTra ensure efficient monitoring of radioactive materials.

SPECTra allows for traceability of radioactive waste.

Bradford Teaching Hospitals NHS Foundation Trust has chosen LabLogic’s SPECTra to manage production of SPECT tracers in its radiopharmacy. During a recent visit by Bradford’s team to LabLogic’s head office for training, Quality Lead Olivia Boustead outlined the challenges faced by radiopharmacies which still relay on paper-based systems.

You can find out how SPECTra is helping to overcome these issues by watching the video or clicking the button below. 

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Product Specialist Adam Brown caught up with Operational Manager Shaun Johns from the Radiopharmacy at Sandwell & West Birmingham Hospitals NHS Trust, who has been working closely with LabLogic to configure and develop SPECTra software.

The department is based at Birmingham City Hospital and is a central supplier to other hospitals in the local region, mainly manufacturing Tc-99m radiopharmaceuticals in multi-dose vials.

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In one of its biggest UK PET projects to date, LabLogic is supplying a complete PET QC solution including Tracer-QC, PETra and SPECTra to the brand new Molecular Imaging Research Centre (MIRC) at Castle Hill Hospital.

The pioneering research centre is a partnership led by the Daisy Appeal between Hull University Teaching Hospitals NHS Trust and the University of Hull.

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