RaPET GMP software - 恩典科研股份有限公司

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首頁產品介紹 Eckert & Ziegler 品管系統 RaPET GMP software

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產品名稱

RaPET GMP software

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產品簡介

GMP Compliant Software

RaPET Chromatography Software

Very reliable and easy-to-use evaluation software consisting of a GMP database ensuring compliant documentation

Please note

The software is only available for our legacy systems Flow-Count and Mini-Scan. MiniScanPRO and AR-2000 systems use the new RaPET-Lab analytical workflow management software.

RaPET Chromatography Software is a comprehensive chromatography data collection and evaluation package specifically configured to work with Eckert & Ziegler products, such as Flow-Count and Mini-Scan.

RaPET Evaluation Software is part of the RaPET Chromatography software package.

Researchers and production personnel can adjust methods, set up sample runs and view data collection in real time. RaPET Chromatography Software is designed to work with radioactivity measurements in HPLC and TLC systems and has features such as half-life corrections for chromatography with short-lived isotopes, background correction, multi peak fitting and full GMP and 21 CFR Part 11 compliance for electronic signatures. The software features include real-time data display, auto-scaling, and GMP database with batch reporting and data export.

Data export functions link RaPET Chromatography Software data to other applications including word processing and spreadsheet analysis. The software can be used in all regulated environments for full cGMP, GLP and 21 CFR Part 11 compliance including audit trails.

Applications

• Routine quality control of 68Ga, 177Lu, 90Y, [18F]FDG, 99mTc, 123I, 11C, 13N radiopharmaceuticals

• TLC of radiopharmaceuticals labeled with gamma or beta emitting isotopes

• Radio-HPLC for determination of pharmaceutical purity (99mTc, 111In, 125I, 123I, 131I, 90Y)

• HPLC analysis of 125I, 11C and 32P labeled compounds

Features and benefits

• Real time display of data analysis

• Easy-to-use and intuitive

• Powerful evaluation and reporting facilities

• FDA 21 CFR Part 11 compliance for electronic signatures

• GLP/GMP compliant with audit trails

• SQL database for data storage

• Data export for interfacing with other applications

• Data collection from Eckert & Ziegler Radiopharma products and detectors

Equipment

An interface box (IFB) is included to link the computer and radiation detection device via a USB interface. The box receives pulse outputs from the detector, then counts and digitizes them. Connection for a start/stop signal is also included.

RaPET Software for radiochromatography data acquisition and analysis of radio-HPLC, TLC, UV and other detectors is available for Flow-Count, Mini-Scan, PET Metabolite, Modular-Lab Analytical HPLC.

Data analysis

RaPET Evaluation Software offers an intuitive range of tools for chromatogram evaluation. Many of these tools have been designed for use with specific applications such as radio-TLC of FDG samples. Backgrounds can be accurately defined and subtracted. For work with short lived radioisotopes the software can automatically correct for radioactive decay.

Audit trails and electronic signatures

RaPET Chromatography Software comes with full audit trail functions for regulatory compliance. Audit events are selectable at the system level to allow individual clients to define the key critical data modification points that require an audit record.