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iPACS® – GLP
FDA 21 CFR part 11 compliant GLP solution
The iPACS® GLP is a FDA 21 CFR part 11 compliant GLP data archiving and audit management solution. It is designed for pharmaceutical and large pre-clinical imaging laboratories. Control project states and secures reliable records with extensive audit management and reports generation support while maintaining all projects under version control.
1 GLP archiving and audit management
- Associate relevant metadata or study information with projects and images with customizable study forms (e.g., injected dose, body weight, calibration unit, etc).
- Includes iPACS reporting module that enables accelerated report generation for relational database, images, movies, etc.
- Enhance workflows with advanced batch analysis processing modules (Xenograft Tumor & Optical Segmentation Tools).
- Uses project-tree data organization with role-based authorization for image study management of image and non-image data.
- Supports storing and indexing of image data sets across multiple modalities (CT, PET, SPECT, MR and Optical).
- Includes an extensive query function to search over image metadata.
- On-site installation and training included – we connect your imaging systems.
- Optionally delivered on a HP Proliant ML350 G6 Special (Intel Xeon Processor, 4GB RAM, 6TB of SATA RAID5 disk storage).
Easy data transfer
- Enhance productivity with bidirectional communication between iPACS and VivoQuant™, offering a seamless solution for managing, viewing and analyzing image data and associated files.
- Batch transfer data from DICOM clients and storage drives.
- Share data easily via public links and iPACS dropzone.
- Access the iPACS web-based server from any terminal with authenticated network access (Supported Web Browsers: Internet Explorer 8+, Chrome, Firefox and Safari).
- Securely sync to inviCRO hosted iPACS for remote cloud access (available upon request).
iPACS GLP can take all or some of the functionalities from iPACS. inviCRO provides consulting work to determine your audit management needs and develops a customized GLP solution for your imaging data in collaboration with your IT department.
21 CFR Part 11 data management
- GLP archiving solution incorporating full audit management.
- Data under version control requiring electronic signatures.
- Comprehensive audit reports can be generated at any time when provided with the history of a project.
Electronic record keeping
- A: Store all data with full version control.
- B: Attach a log message to each version of a file.
- C: Authorized by electronic signature.
- D: View history of data under version control.
- E: Download and restore any previous version.