PET Laboratory Information Management System (LIMS) Complete Process Management Solution for PET Facilities

Transcription

1 PET Laboratory Information Management System (LIMS) Complete Process Management Solution for PET Facilities

2 Automation - bring it all into one place Data acquisition Relevant information from all key equipment is acquired directly into PETra. Mobile Hand-held Cyclotrons Synthesis Units Dose Calibrator GC HPLC Radiochromatography data systems Seamless interface with Laura radiochromatography software for direct capture of data. TLC Flexible configurations ph / Endotoxin / Weighing etc.

3 Reliable documentation Raw materials tracking Keep track of all raw materials such as reagents, solvents, and custom kits from start to finish. Stock Control Site / Dose Information Consolidated batch reports All relevant processes including sample ID, detailed method description, complete record of all data, statement of the results, materials tracking and accepting and releasing a batch. Dose Vials Improve workflow

4 Keeping track of your inventory 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. Upon usage, the stock levels are automatically adjusted and an inventory report can be generated for ordering stock. Inventory can also be sorted by expiry date to ensure stock rotation. Barcode generation 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. Label design Before a radiopharmaceutical is shipped, it is required to have an acceptable label adhered to its transport vial. Various labels can be designed, with images and company logos inserted at the touch of a button. Instrument interfaces Cyclotron, Synthesis Box, Dose Calibrator, Endosafe PTS, radio-hplc, GC, radio-tlc, etc All data can be automatically captured directly to PETra, no manual transcription, and therefore no transcription errors.

5 Environmental monitoring Record and monitor the appropriate environmental parameters. Dose calculator Prior to commencement of a production run the required doses with a few parameters can be entered into PETra and the dispensing dose will be automatically calculated. It is possible to print this information onto the labels. Pre-production checks Before a production begins, the facility is prepared by following your SOP s. Rather than having to go back to a desktop PC, PETra Mobile can be installed on a hand held PC which can be carried around the facility. Upon completion, the hand held PC data is transferred to the network and assigned to your production run. Trending Any function can be analysed over time to look for variations in instrument performance.

6 Regulatory compliance PETra is designed to fully support the regulatory requirements and specifications for both laboratory operations and laboratory software design. The system allows for System Manager control of signature points on key events. Each area of configuration that could require a signature is configurable. Administrators can disable signatures, set a silent signature which doesn t require any action on the user part, set a single or 2 signatures (the second signature normally being approval of the first). Signed electronic records contain information associated with the signing that clearly indicates all of the following; 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 Security PETra has a comprehensive and flexible security structure, which is used to control access to menu items and form-level functions. Given that PET production may become more tightly regulated, it is important that PETra is able to guard against unauthorised access. Therefore, security is assigned on a user-by-user basis. System and batch level roles can be assigned to users to ensure that only those individuals who have the appropriate rights assigned to them can perform their necessary function. PETra specifications Client: Hardware Minimum Pentium 800MHz. Minimum SVGA 1024x768, 256 colours. Minimum 256Mb RAM (512 preferred). Minimum 100Mb of free space. Operating system Microsoft Windows 7 Vista Server 2003 XP 2000 professional. Storage ~ 30Mb for a local clients installation. ~ 20Mb free required after installation. Installation It is possible to store the PETra executable program and online help either locally or on a network fileserver. Issues to consider in order to make this decision include the fact that storing the executable on a central server will simplyfy updating the software and also client installation process. Conversely, storing the executable locally will reduce network traffic and improve the performance of the software. Server: Hardware, operating system and Oracle/MS SQL Server software. Due to the nature of Oracle and the client/server architecture of PETra, the server platform is largely immaterial. PETra supports the following Oracle server versions; Oracle 8i Oracle 9i Oracle 10g. PETra supports the following Microsoft SQL Server versions: SQL Server 2000 SQL Server Typical Platforms Pentium IV running Server 2003 Oracle Server 10g. Several varieties of Unix servers with Oracle 9i. Storage Default initial sizing of the database at install-time is 10Mb. A typical storage requirement per batch is 1-1.5Mb.

7 Other LabLogic related products Flow-RAM is the new and compact radio HPLC detector for PET and SPECT applications. This innovative PET and SPECT radio TLC scanner also offers many of the features afforded by the Flow-RAM. Posi-RAM is a PET Metabolite radio HPLC detector that uses two BGO crystals that work in coincidence resulting in excellent signal to noise ratio. Laura Radiochromatography Data System Instrument control, digital data collection, analysis and reporting. All achieved using the industry standard radiochromatography data system Laura. Laura has been the recognised industry standard software for radiochromatography for the best part of 20 years. The latest evolution of Laura features control of many of the world's leading HPLC and radio detector systems to provide a single point of control for the entire radiochromatography analysis. Laura also features; Half-life correction. Seemless interface with PETra. Scaleable solution from stand-alone to enterprise level. GLP and 21 CFR part 11 compliance options. Document management system. Automatic peak finder. Unique summary table function for data comparison. Powerful reporting and analysis tools. All trademarks are acknowledged. Compatible with:

8 Other LabLogic products & services Service & Support Users of our instrumentation can benefit from our comprehensive, fully inclusive instrument service and support. We provide complete service and support for all of our customers to give reassurance that if things go wrong, help is only an or phone call away. Service. Support. Reassurance. Validation Services We believe that nobody knows and understands our systems and the needs of the PET laboratory better than we do, which is why we have put together our Validation Service to enable you to implement and get maximum value from your investment as quickly as possible. We work as a partner with your System Manager and users to provide a tailored Validation Plan suited to your needs. Our Validation Specialists incorporate years of experience in GLP system validation, detailed knowledge of our systems, together with other industry standard systems to help you meet your Company's requirements. Industry Specialists. For other instruments in our range please visit our website: Europe LabLogic Systems Limited, Paradigm House, 3 Melbourne Avenue, Broomhill, Sheffield, England, S10 2QJ, U.K. solutions@lablogic.com Tel: +44 (0) Fax: +44 (0) USA & Canada LabLogic Systems, Inc. East Pointe Park, 1040 East Brandon Blvd. Brandon, FL sales@lablogic.com Tel: Tel: INUS (4687) Fax: Design by bluestrawberryelephant.co.uk 2011.