Secure review & export of data

Data Extractor

The Comet Assay IV Data Extractor provides secure extraction of comet assay measurement and audit data from an Oracle database.

Secure review & export of data

In GLP-regulated environments, data generated by Comet Assay IV is often saved to an Oracle database in order to ensure security and integrity of study data. The Data Extractor is a powerful optional module for viewing, searching and filtering this data. The Data Extractor also gives authorised users the power to approve and reject data, archive studies and export result and audit data.

Features

• Easy browsing, sorting and filtering of all your result and audit information.
• Approve and reject your data with the Data Extractor’s electronic signature system.
• Securely archive your data in accordance with OECD guidelines.
• View images of every scored cell alongside measurement data and audit trails.
• A range of secure export formats including Excel, XML and encrypted formats.
• Works with System Access Manager for GLP and FDA 21 CFR Part 11 compliance.
• Comprehensively tested and validated in accordance with our Quality Management System which is approved to ISO 9001:2008 incorporating ISO 90003.

Filter, sort and search your data to quickly locate data for a specific study

The Data Extractor for Comet Assay IV allows authorised users and auditors to easily browse and export result and audit data from a secure Oracle database. The Data Extractor makes it easy to locate any past data for review or statistical analysis.

Data can be sorted and grouped quickly by clicking on column headings, and the Filter builder offers powerful data filtering capabilities allowing the creation of complex search criteria for selecting data in any conceivable way. Filters can also be saved for future use.

Sign and archive your data in accordance with OECD guidelines

The Data Extractor is essential for those wishing to archive their data in line with OECD guidelines, providing a sophisticated electronic signature and archiving system. Authorised users can quickly locate data to be signed or archived using the filtering system.

In order to maintain the integrity and accessibility of your data, the Data Extractor marks data as archived within the database. This not only helps ensure the integrity of your data by avoiding any potentially dangerous export and purge operations, but also means you can still view the study and reconstruct reports for auditing and verification.

Batch export of results and images for efficient data processing and auditing

The Data Extractor allows results files and images of scored cells to be exported in batches. This means you can export all the results for a study in one group. These files can be named automatically using study codes, slide IDs etc. for easy identification.

Exporting images of scored cells can be particularly useful for auditors and study directors. Each cell image is stored with result data and information on exactly how the user scored the cell. These images can be opened in Comet Assay IV and rescored to verify the results attained.

Auditing and user administration helping you meet regulatory requirements

All audit data collected during the use of Comet Assay IV can be viewed by authorised users within the Data Extractor and exported. The Data Extractor is protected using the same system of user control as Comet Assay IV, allowing for centralised administration of all users. Five access levels are incorporated within the system, each with privileges that can be independently customised. This not only aids the meeting of regulatory requirements, but provides flexibility for your specific demands.

A range of secure export formats for flexible data transfer and reporting

With the Data Extractor, users can browse, group and filter data within the database and export it for use with the Spreadsheet Generator macro or any other data processing and reporting tools. Users can export study data to Excel, XML and encrypted formats. This allows for ultimate portability, integration into existing data management systems and security of data.

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