PETra

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

• The printed name of the signer 
• The date and time when the signature was executed
• The meaning (such as review, approval, responsibility, or authorship) associated with the signature

Audit Trial
PETra  provides auditing facilities so that data can be checked and validated as described in FDA 21 CFR part 11 Section 11.10 paragraph (b): “The ability to generate accurate and complete copies of records in both human readable and electronic form suitable for inspection, review, and copying by the agency”.  

PETra provides system level control for auditing and all auditing should be enabled for FDA 21 CFR Part 11 compliance.  Whenever a change is made to the data, PETra adds that change to the audit trail.  The reason for any change is requested (or selection from a user predefined list), and the previous value, new value, operator and the date/time is recorded.

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.  

Access Levels
Hierarchial levels of access  can be configured within PETra.User GroupsUsers groups can be created so that relevant  notifications are sent to appropriate users. Training RecordsPersonnel training records can be maintained within PETra and access rights within the system linked to their training and qualifications. 

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

Quality management systems in PET stem from key regulations that the FDA and other regulatory bodies enforce. Regulations such as 21 CFR Part 211 are one example of this.  Under this regulation, a quality management systems definition covers the concept of a quality control unit, which is responsible for overall quality management systems. The quality control unit is primarily responsible for documentation (procedures, SOPs, policies, etc.) and control of all documents that impact product quality and safety. Naturally, PETra users can benefit from this optional functionality.

SOP Management

This module provides an information portal for all types of documents of value within the PET facility and not just those subject to formal change control. Principally, this PETra module makes the correct information readily available at the point of need, when needed and in a form that is easily understood. There is the option to use the built-in writer or import existing documents in Word which are subsequently only available through the closed PETra system with the benefit of compliance. 

Wherever formal change control needs to be demonstrated, this module addresses the complete document management lifecycle. Every action and notification associated with the following is automatically managed, thus eliminating the need for paper chase;

• Change Requests
• Drafting
• Approvals
• Distribution
• Publishing
• Document Registers
• Change History

Documents can be stored in folders providing quick access in the context of whatever is being worked on. Additionally, documents can be linked to the applicable steps in the batch for easy access to documents instantly.

Electronic signature ability, in line with 21 CFR Part 11 regulations for Electronic Records and Electronic Signatures is available throughout the system.

Out of Specification (OOS)

In the context of PETra, the term OOS results includes all test results that fall outside the specifications or acceptance criteria established in drug applications, drug master files (DMFs), official compendia, or by the manufacturer. The term also applies to all in-process laboratory tests that are outside of established specifications. By utilizing this PETra function, the investigational findings are maintained within PETra and can be reported at any time and progressed to CAPA, if applicable.

Deviation

Despite the fact that equipment is qualified, staff is trained and that processes have been validated, the production of PET radiopharmaceuticals can present situations where prescribed workflows are not observed or processes fail to deliver the expected results.  For this reason it is important not only to define the workflows for production in "normal cases," but also to specify how such deviations are to be handled. This will ensure that acceptable product quality can be obtained even in the event of unforeseen circumstances. This optional module in PETra, through its use of predefined form, allows for efficient and consistent data capture along with immediate corrective action.

Change Control

Change control is a well-known CGMP concept that focuses on managing change to prevent unintended consequences. The CGMP regulations provide for change control primarily through the assigned responsibilities of the quality control unit.  Effective change control activities are key components of any quality system. This optional PETra module empowers its users to make changes subject to the regulations based on the variability of materials used in manufacturing and process improvements resulting from knowledge gained during a product’s lifecycle.

Corrective and Preventative Action (CAPA) Management Module

CAPA is another well-known CGMP regulatory concept that focuses on investigating, understanding, and correcting discrepancies while attempting to prevent their recurrence. This optional PETra module provides a centralised reporting system to manage the complete CAPA lifecycle. Its implementation provides the ability to solve problems quickly and thoroughly to minimize the impact and lessen the chance of re-occurrence through the following steps;

• Remedial corrections of an identified problem
• Root cause analysis with corrective action to help understand the cause of the deviation and potentially prevent recurrence of a similar problem
• Preventive action to avert recurrence of a similar potential problem

This module utilizes pre-defined reports to provide a consistent process that ensures information is captured and managed effectively. The key to reliable, accurate and efficient data entry is the workflow process which PETra addresses through the use of the template that also provides the ability to upload other relevant data which may be in different formats, all within a closed system.

Notifications

Notification function is very flexible and can be used for a wide range of circumstances.

Notifications can be automatically generated by PETra in response to an event – so when a monthly instrument performance test is due, an SOP is due to expire, Personnel Training Records require updating etc.  the relevant staff is notified of this in advance.

The messages can be forwarded to individuals or a group of individuals based upon the notification message and its relevance. For example, if an SOP is due to expire the Author will be notified of this. Once the SOP is reviewed and updated, the Author will then set up a Notification Message such that all the individuals impacted by the revision and update of the SOP are notified.

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.

Synthesis of any radiopharmaceutical generally requires multiple raw materials. By implementing the Inventory Module in PETra, you can keep track of your entire inventory along with the respective QC data electronically.

Labels & Barcodes

To ensure compliance and traceability each product, raw material etc. is required to have an eligible label on it.  The PETra Label Designer provides for configurations of 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. All labels can be created with the additional option of using barcodes to make the tracking simpler.  Alternatively suppliers own barcodes can be used.

Sometimes, it is necessary to make up “kits’’ that contain numerous raw materials, the tracking of this can sometimes be challenging. However, by implementing PETra you will be able to automatically track the components and automatically generate a tracking barcode.

Stock Control

A key module within PETra is the powerful inventory stock control module. This allows full chain-of-custody management of all inventory items from cradle to grave. This includes options for dealing with the ordering of items, receipt, quarantine (including on-line collection of relevant QC data) and monitoring and prompting of expired items. During production preparation items can be simply scanned into the batch using barcodes and the records are automatically checked and updated to ensure complete traceability and compliance. Add to this powerful search/find functionality, first in first out rules, user defined re-order levels and an inventory overview section the system really does provide a comprehensive system to deal with all your inventory management needs.

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.