PETra

PET LIMS Software

During the various phases of PET production, facilities have to manage data from a range of equipment and software packages, resulting in multiple outputs and reports. What’s unique about PETra, is that it captures data directly from all equipment used in the process.

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

Interfaces to all Equipment
PETra is capable of connecting with all the equipment used, either by interfacing directly with the instrument or connecting to the relevant software package. PETra is compatible with all leading manufacturers.

Through managing data electronically PETra significantly improves workflow efficiency including:

• Automatic calculations
• Storing site, customer and dose information in one place
• Step-by-step prompts for pre-production checks
• Capturing data directly, eliminating transcription errors
• Batch reports ready at the click of a button without having to collate a range of reports
• Electronic signatures Not having to chase missing manual signatures
• Eliminating human errors on quality records
• Managing documents without a paper trail
• Built in procedures for all quality management tasks such as OOS, CAPA and Deviations
• Sending user and group notifications
• Having a secure and compliant system
• Trending any data
• Automatic inventory management using a barcoded system and notifications 

LabLogic’s decades of experience and expertise in providing solutions within highly regulated environments means that PETra is an unrivalled solution for PET facilities. 

Our system is built to ensure compliance with GMP, Pharmacopoeia and FDA regulations.  

'PETra is a great solution for dealing with regulatory requirements specifically those from the FDA. My role as a responsible person is made so much easier when I can ensure all the data points have been collected, data is stored safely and I have instant access to all vital records'   

Multi-site facilities can standardize production of their radiopharmaceuticals with PETra.
Each site can be configured to ensure the same processes are being routinely carried out, removing inconsistencies.

“The implementation of PETra has strengthened our Quality System by exposing inconsistencies and requiring greater standardization of existing processes.”
Jose Zayas, Director GMP Compliance, Triad Isotopes

Regulatory Compliance is a key feature of PETra, evident throughout the user experience and in the underlying functional design.

Electronic Signatures 

• Electronic signatures are linked to a user’s security profile.
• Single or second signatures are possible for any process or task.
• ‘Silent’ signatures allow smooth workflow, whilst ensuring actions are fully audited.
• Auditing meets GMP Annex 11 and FDA 21 CFR Part 11 requirements for recording name, date/time and reasons for an electronic signature

Audit Trail

• PETra meets FDA 21 CFR, Part 11 auditing requirements to generate accurate and complete copies of records to allow regulatory body review.
• PETra audit trail can report all changes made to system configuration or to data values, including:
  
  • previous value and new value.
  • operator involved, along with date/time of the change.
  • reason for change

User Settings

• Settings for each individual are easily managed with PETra. You can quickly and simply configure a user’s settings for access, training and statistics.

User Groups

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

Training Records

• Personnel training records can be maintained within PETra and access rights within the system linked to their training and qualifications.

The QMS module in PETra ensures that every task can be completed in accordance with your company’s controlled procedures and in compliance with the applicable GMP-regulations. Controlled documentation can be easily and securely accessed throughout the PETra application, completely eliminating the need for a paper chase. 

SOP Module

• Provides an easy and intuitive way of managing SOPs.
• Operators are able to view the latest version of any SOP within the relevant section of the PETra application.
• Reminders can be set to notify the responsible person/group of when an SOP is due for review.

Document Management Module

• The Document Management facility is an information portal for storing and accessing all types and formats of documents, not just those documents which are subject to formal version-control.

Out of Specification (OOS) Module

• Provides electronic management of OOS investigations.
• OOS reports can be generated automatically during execution of a batch and can be retrieved at any time or progressed to a CAPA, if applicable. 

Change Control (CC) Module

• Allows users to document controlled changes to GMP-relevant processes.
• Proposed CCs can be drafted, reviewed and authorised and their progress easily tracked through to completion.

Deviation Module

• Using pre-defined template forms this module allows the recording of any incident where a deviation from an established procedure has occurred.
• Allows for efficient and consistent reporting, including recording and auditing of any immediate actions/decisions taken following the deviation. 

Corrective Action and Preventive Action (CAPA) Module

• This module is designed to document the progression of CAPAs quickly, in order to help improve process quality and thus prevent reoccurrence of common issues.
• The logical CAPA process in PETra ensures that the necessary stages of a CAPA are effectively documented from planning, through execution and reporting and allows supporting documentation to be appended. 

Notifications

• Notifications in PETra drive communication between users or group of users within the system.
• They can be automatically generated in response to a new or scheduled event, such as operational alerts, or can be used to communicate group messages or used to send reminders of important upcoming tasks, such as maintenance or calibration. 

Trending Module

• In PETra’s Trending Module any parameter or variable can be analyzed over a specified period of time, or over a series of batches, to identify performance trends, e.g. synthesis yield, pH value, radionuclidic purity, etc

A key feature of PETra is the system’s ability to interface with all the key instruments and data systems from the complete production process. Each piece of equipment, to which PETra connects to or interfaces with, is automatically registered within PETra. Arrange of tools are provided in order to help manage the instrumentation.

Instrument Maintenance

To ensure that the downtime of each piece of equipment is minimized and that the facility operates at the best possible efficiency, it is essential that the equipment used is regularly maintained, and that users are notified in advance of when the required maintenance is due in order for them to plan their production schedule around that. In PETra, this process is automated and records for each piece of equipment can be fully maintained based upon a number of key parameters, namely; Supplier, Instrument Name, Instrument Type, and Frequency of the required maintenance or tests. The frequency may be defined as manually, week days, weekly, monthly, quarterly, annually or biannually and notifications set up accordingly.

Instrument Interface 

This module lets the site manage the specific make / model and interface methodology for all instrumentation and interface systems A wide range of Cyclotron, Synthesis Modules, Dose Calibrator, Endosafe PTS, radio-HPLC, GC, radio-TLC, MCA, TLC Visualizer, pH meters, balances, Osmometers, Turbidmeters, Automatic dose dispensing systems, etc… All can be automatically captured directly to PETra, no manual transcription, and therefore no transcription errors.

Instrument Trending

Any function can be analyzed over time to look for variations in instrument performance or any other parameter. The data is displayed graphically and in a tabulated format with quick links whereby clicking on any point will take the reviewer to the relevant section of the batch in question. This provides for rapid review of instrument performance and allows operators to identify early warning signs of requirements for equipment maintenance.

Production and testing of radiopharmaceuticals requires multiple raw materials. The barcode-driven inventory management module enables key stock and consumable material status to be electronically tracked.

Labels & Barcodes

• Barcode can be assigned automatically in PETra or existing item barcodes can be retained.
• Various label types can be customized in the PETra Label Designer to include, for example, barcodes, logos, dates and other batch-specific information.

Stock Control

• This powerful module provides comprehensive and fully traceable chain-of-custody management of all your inventory.
• The status of inventory items is traceable through each logical stage of the process:
  
  • Ordering of materials.
  • Receipt of materials into quarantine.
  • Release/approval of materials for use (availability) in the GMP process.
  • Use of materials in specific production batches
  • Historical traceability in case of product recall or investigation.
• Inventory stock levels can be efficiently controlled in PETra, via automatically generated notifications, linked to predefined reorder levels.
• Logical first-in first-out rules and first-use expiry updates ensure that PETra provides a comprehensive inventory management tool for your business.

Radioactivity Stock and Waste Management Module

• Allows monitoring of the type and total amount of radioactivity held on site.

PETra can use inputs from the online dose ordering module along with details of manufactured and delivered doses to automatically generate customer invoices.

Online Ordering

• Customers can place orders via the online ordering module.
• Orders can be restricted to customer-specific products, with the ability to apply customer-specific pricing.
• Online-generated orders can be sent to the orchestration module (for a multi-site operation) or directly to the Production Planning Tool for individual sites.
  

Production Planning Tool

• The production planning tool allows detailed planning of radiopharmaceutical production batches on a single site.
• The module takes as its input orders for individual or multiple doses received:
  • directly from customers. 
  • from an on-line ordering system.
  • from a centralised Orchestration Module.
• The module allows the production planner to:
  • confirm that the required orders can be produced with the available site resources (personnel, materials cyclotron/ synthesis modules, time & delivery constraints, etc.)
  • create an efficient production plan, meeting the ordered dosing schedule.if necessary, communicate with a central orchestration
  • if necessary, communicate with a central orchestration planning module (see below) to formally accept/reject a request for production.

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.

Orchestration Module

PETra’s orchestration module allows a multi-site organization to optimize the production of radiopharmaceutical doses amongst its available manufacturing sites, for any given day.

Orders for multiple customers received via a central on-line dose ordering system are input to the orchestration module.

The orchestration module allows the central planning function to allocate the optimum production site for each set of doses, based on a number of factors, including:

• manufacturing site availability / suitability.
• efficiency of pooling/transporting doses.
• requirement to provide late or unplanned (back-up) orders.
• requirement to meet other constraints, such as transit times or using specific transport methods.

Obtaining GMP certification in an expanding market

Juan Carlos Manrique-Arias (left) with LabLogic’s Wayne Houston and Gavin Rowlett during an onsite IQ and OQ validation.

The leading healthcare provider in Spanish-speaking Latin America – Auna – is implementing PETra at a cyclotron in Monterrey, Mexico, where a range of isotopes are produced to supply three high-complexity hospitals: OCA Hospital, Doctor’s Hospital, and Doctor’s Hospital East, as well as distribute doses to other PET centers. Dr. Juan Carlos Manrique-Arias is the site’s manager, where he oversees the production of many common medical radioisotopes such as ⁶⁴Cu, ¹²³I, ¹²⁴I, ⁸⁹Zr, ⁶⁸Ga, ¹⁸F, ¹¹C, and ¹³N.

As nuclear medicine expands in Latin America, regulators are keen for new and existing radiopharmacies to demonstrate proper compliance with GMP and other guidelines. Dr. Manrique outlined the challenges of managing radiopharmaceuticals production without a modern electronic system in an expanding market, and how this has changed with the use of PETra.

We spoke to Juan Carlos about how PETra has allowed his facilities to obtain GMP certification following inspection by Mexican regulators. Click the button below to find out more.

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Driving compliance, efficiency, and innovation in medical radioisotope production

BV Cyclotron is a leading manufacturer of radiopharmaceuticals based in Amsterdam in the Netherlands that produces a range of common and novel radiotracers for both research and clinical use. It is one of the biggest producers of ¹⁸F tracers in the Netherlands, but also produces KryptoScan^TM (⁸¹Rb/^81mKr) for distribution in Europe together with Curium and ⁸⁹Zr for delivery all over the world together with Revvity.

Arnold Spaans is BV Cyclotron’s Development Manager who originally managed PETra’s implementation with LabLogic’s support. The concept of using a digital solution to replace paper records was raised when BV Cyclotron prepared to move from its previous PET production site to its current facility at the Amsterdam UMC Imaging Center.

Find out what Arnold had to say about PETra by clicking the button below.

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Eliminating paper records in PET/QC with PETra

PET Pharm Biotech is a PET radiopharmaceutical CDMO and the first of only two PIC/S GMP-certified companies in Taiwan, supplying hospitals and cancer centers in the capital Taipei and across the north of the island. The company has implemented PETra to eliminate paper records and improve efficiency in PET production.

General Manager Terry Lin said, “We specifically introduced PETra to improve our quality systems. Until now, we have been recording our batch records by hand to paper, which is not good for data integrity or efficiency.

"PETra will reduce our manpower hours and improve our efficiency. We will abandon all paper records within the next three months. We believe the improvements that PETra will bring to PET Pharm Biotech will greatly benefit Taiwanese nuclear medicine."

You can find out more about what Terry had to say by clicking the button below.

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Managing a new PET production facility using PETra

Örebro University Hospital in Sweden has chosen LabLogic’s solutions for its new radiopharmacy which is being built to supply its current and future PET/CT cameras with tracers radiolabelled with Fluorine-18 initially and eventually Carbon-11, Gallium-68, and Oxygen-15. The radiopharmacy will compound all its radiopharmaceuticals through a GMP-compliant pharmaceutical quality system as described in the European Pharmacopoeia.

The hospital’s radiopharmacy will use PETra to manage the production and administration of PET radiopharmaceuticals along with LabLogic instrumentation controlled by Laura Radiopharma software. Click the button below to learn more.

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Modernising PET production with PETra

The Turku PET Center in Finland has chosen PETra following a public tender. The center is a Finnish National Research Institute and a collaboration between the University of Turku, Åbo Akademi University, and Turku University Hospital.

Sarita Forsback, Adjunct Professor and Development Manager at Turku PET Center, said, "We have been using a paper system and even tried to build our own in-house PET management software a couple of years ago but failed because of the complexities of such a task.

“PETra will allow us to manage the production of our radiopharmaceuticals along with the associated data, quality control documentation, material handling, and user access, including training records.  PETra is tailor-made for our field. In my opinion, it is the only software solution that is fixed to this business.”

You can find out what else Sarita had to say by clicking to button below to find out more.

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Skåne University Hospital in Lund and Sahlgrenska University Hospital in Gothenburg have chosen PETra LIMS software, as both sites modernise and seek to improve efficiency and compliance by moving away from paper-based systems. These new installations will add to PETra’s existing customer base in Sweden, which already includes Linköping University Hospital, University Hospital of Umeå, and Karolinska Hospital in Stockholm.

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Odense University Hospital is among the three largest hospitals in Denmark and is located in the southern region of Denmark. The PET-center at OUH provides FDG and other radiotracers to its own clinic which has 5 PET/CT scanners and one PET/MR. In addition to this, the radiochemist provides radiotracers to two other hospitals in the region with one more being added in 2021/2022.

Niels Langkjær is Head of Production at Odense University Hospital and said: “Our main products are FDG, NaF and PSMA-1007. We have an annual production of around 400 FDG batches, 120 NaF and 50 PSMA-1007.”

Niels added: “PETra was created with a clear focus on PET productions sites whereas competitors had generic systems which had to be customized to a larger degree increasing cost and time consumed on the project.”

Read the full testimonial here.

Regionshospitalet Herning is a large hospital in Central Jutland, part of the Hospital Unit West.  The Department of Nuclear Medicine at Regionshospitalet Herning started producing its own PET tracer Ga-68-PSMA in 2016 from a generator. The hospital is moving to a completely new hospital at Gødstrup in 2021 where a new PET facility is set up with a cyclotron and PET radiopharmacy equipment.

Lise Falborg, MSc, Ph.D., MPG is Radiochemist at the hospital and said: “We chose PETra PET LIMS to be GMP compliant. The main benefits of choosing PETra as our LIMS system will be user management, integration of inventory and production, the possibility to custom make the formulas in production/QC, audit trail, the possibility to import pdf-files and the release sequence and sign off system.”

Read the full testimonial here.

Karolinska University Hospital is a large teaching hospital affiliated with the Karolinska Institute in Stockholm, Sweden. In 2019, the hospital implemented LabLogic’s market-leading PETra as its Laboratory Information Management System (LIMS) in its PET production facility.

Paul Saliba is a Quality Assurance/Production Chemist at the hospital and led the PETra implementation. He said: “We chose to move to a LIMS system to simplify the work carried out in our labs using paper-based processes, which took up a lot of time and resources. Moving from a traditional paper-based system to a LIMS allows less room for miscommunication and human error with administrative paperwork."

Read the full testimonial here.

St. Olavs Hospital, Trondheim University Hospital is the local hospital for the population of southern Trøndelag, a county in the central part of Norway. The Department of Nuclear Medicine and Medical Physics at St. Olavs set up a brand new PET production facility in 2018 and chose PETra to manage data in a compliant manner. Click here to read more.

LabLogic is supplying a complete PET QC solution including Tracer-QC, PETra and SPECTra to the brand new Molecular Imaging Research Center (MIRC) at Castle Hill Hospital.

Professor Steve Archibald, Professor in Molecular Imaging and Director of the Positron Emission Tomography Research Center, said: “Our aim in the MIRC is to innovate in all aspects of GMP radiotracer production. LabLogic provides the latest internationally leading commercial solutions to streamline radiotracer validation and meet regulatory requirements.

Click here to read the full article. 

Leiden University Medical Center recently set up a brand new GMP radiochemistry facility, aiming to produce [18F]PSMA and other research tracers. The hospital chose LabLogic’s PETra software for its Laboratory Information Management System (LIMS) to manage data in a compliant manner. Read more here.

LabLogic has secured a deal with SOFIE Inc, one of the world's largest PET radiopharmaceutical manufacturers in the world, to supply PETra to SOFIE Inc's 16 radiopharmacies throughout the USA. Read more about the deal here.

LabLogic has successfully implemented PETra within the PET manufacturing facilities of Triad Isotopes. Triad Isotopes prepare radioisotopes and operate a nationwide network of more than 50 nuclear pharmacies. Read more here, and click here to listen to the former VP of PET Operations at Triad Isotopes explain the reasoning for investing in PETra.

The university chose PETra for the combined Nuclear Pharmacy and Radionuclide production facility. The facility, which produces a variety of radiopharmaceuticals for both internal and external use, did not have an electronic information management system prior to PETra. Sally Schwarts, Professor of Radiology, explains the benefits of PETra here.

PETra is the only true commercially available PET LIMS (Laboratory Information Management System).

No you don’t. PETra is a modular system and you can buy modules that you deem most required for your facility.

Installation of PETra will help you in various ways, not least for that it will act as a central repository of all the information in your facility in a compliant manner.

Yes it is. LabLogic has over 25 years of experience of supplying solutions to regulated environments and that experience has been carried over to PETra too.

Yes we do. LabLogic provides validation services to suit your requirements and a validation matrix to assist with this.

Yes you can.

No you don’t.  Upgrade is optional and LabLogic can advise on whether your particular set up would benefit from an upgrade.