A purpose built Laboratory Information Management System

SPECTra is a true Radiopharmacy Laboratory Information Management System (LIMS), designed specifically to improve efficiency and compliance.

SPECTra is based on our market leading PET LIMS system called PETra. Since its introduction to the market PETra has quickly become the industry standard following successful installations in some of the world’s most prestigious and regulated PET facilities.

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 all 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.

Improved Efficiency

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.

Improved Compliance

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.

Standardize Production

Multi-site facilities can standardize 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.

Orders

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 customized 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.

Preparation

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.

Production

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.

Quality Control

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”.

Dispensing

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.

Product Release

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 test have been completed successfully, the responsible person can electronically sign off the release.

Batch Reports

All data is consolidated in a single, central repository. This can be printed to a user defined batch report.

SPECTra also features other useful modules including:

Regulatory Compliance

Regulatory Compliance is an essential feature of SPECTra, built to meet FDA 21 CFR part 212 / 11 requirements.
 
Electronic Signatures
A signature can be required in any area of the system.
 
All signatures are fully configurable.
 
Adminsitrators can disable the signatures, set a silent signature or require a single and double signature.
 
Compliant with FDA 21 CFR part 11 requirements in section 11.50.

Audit Trial
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
Hierarchial 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.

Quality Management

The quality management module in SPECTra, ensures every action is completed following predefined processes. Documentation is therefore easily and securely accessed throughout the system 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 Preventative Action (CAPA)

This module is designed to solve problems quickly, minimize 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 analyzed over time. This may be to look for variations in instrument performance or any other parameter such as synthesis yields.

Accounting

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.

Instrument Management

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.

Inventory Management

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 customized 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.

Documents