Pathomation’s PMA.core version 3.0.0. is now CE-IVD certified.
PMA.core has many features. Below you can find a list of features that are now certified for clinical use or primary diagnosis:
| Category | Code | Description |
|---|---|---|
| General requirements | URS-G-001 | Users have to login with a username and password |
| URS-G-004 | The software version can be consulted. | |
| URS-G-005 | End-users can notify Pathomation if there is an issue with the software | |
| URS-G-106 | The software must have a licensing scheme | |
| URS-G-107 | Provide support for HTTPS communication (in addition to HTTP) | |
| URS-G-108 | A webservice-based Application Programming Interface (API) is available | |
| URS-G-2000 | A historical overview of license updates is available | |
| URS-G-2001 | License management can be handled online without (physical nor virtual) server access | |
| URS-G-2002 | Product owners are notified when the license expires | |
| Storage media | URS-SM-003 | Images can be added from multiple locations (paths) |
| URS-SM-2003 | Slides can be read from local server storage (hard disk) | |
| URS-SM-2004 | Slides can be read from network drives (UNC paths) | |
| URS-SM-2005 | Slides can be read from Amazon S3 compatible storage | |
| URS-SM-3006 | Slides can be read from Azure blob storage | |
| URS-SM-3007 | Slides can be read from Azure Data lakes (Gen2) | |
| File format (brightfield) | URS-FB-002 | Support the “3DHistech MRXS” file format (brightfield) |
| URS-FB-100 | Support the “Hamamatsu NDPI ” file format (brightfield) | |
| URS-FB-101 | Support the “Aperio LEICA SVS” file format (brightfield) | |
| URS-FB-102 | Support the “Aperio LEICA SCN” file format (brightield) | |
| URS-FB-103 | Support the “Ventana Roche BIF” (with and without TIFP) file format (brightfield) | |
| URS-FB-104 | Support the “Olympus VSI” file format (brightfield) | |
| URS-FB-105 | Support the “Generic JPG ” file format (brightfield) | |
| URS-FB-106 | Support the “Generic PNG” file format (brightfield) | |
| URS-FB-200 | Support the “Generic TIFF” file format (brightfield) | |
| URS-FB-201 | Support the “Zeiss ZVI” file format (brightfield) | |
| URS-FB-202 | Support the “Zeiss CZI” file format (brightfield) | |
| URS-FB-203 | Support the “Nikon ND2” file format (brightfield) | |
| URS-FB-3000 | Support JPEG 2000 encoded slides (brightfield) | |
| URS-FB-3002 | Support the “Sakura SVSLIDE” file format (brightfield) | |
| URS-FB-3003 | Support the “Motic MDS” file format (brightfield) | |
| URS-FB-3004 | Support the “Motic MDSX” file format (brightfield) | |
| URS-FB-3007 | Support the “Olympus Webview” file format (brightfield) | |
| URS-FB-3008 | Support the “Microsoft Deep Zoom .DZI” file format (brightfield) | |
| URS-FB-3009 | Support the “Hamamatsu VMS” file format (brightfield) | |
| URS-FB-3010 | Support the “Huron Technologies TIFF” file format (brightfield) | |
| URS-FB-3011 | Support the “Aperio / Leica CWS” file format (brightfield) | |
| URS-FB-3014 | Support the “Open Microscopy OME-TIFF” file format (brightfield) | |
| URS-FB-3015 | Support the “Menarini DSight Raw INI” file format (brightfield) | |
| URS-FB-3016 | Support the “Zoomify ZIF” file format (brightfield) | |
| URS-FB-3017 | Support the “Smartzoom SZI” file format (brightfield) | |
| URS-FB-3018 | Support the “Objective Imaging (Glissando)” file format (brightfield) | |
| URS-FB-3020 | Support the “Unic Tech TMAP” file format (brightfield) | |
| URS-FB-3021 | Support the “Jpeg XR JXR” file format (brightfield) | |
| URS-FB-3022 | Support the “KFBio KFB” file format (brightfield) | |
| URS-FB-3023 | Support the “GE Omnyx JP2” file format (brightfield) | |
| URS-FB-3024 | Support the “GE Omnyx / Inspirata RTS” file format (brightfield) | |
| URS-FB-3025 | Support the “Philips iSyntax” file format (brightfield) | |
| URS-FB-3026 | Support the “Philips TIFF” file format (brightfield) | |
| URS-FB-3027 | Support the “Omero ZARR” file format (brightfield) | |
| File format (fluo) | URS-FF-002 | Support the “3DHistech MRXS” file format (fluo) |
| URS-FF-100 | Support the “Hamamatsu NDPIS” file format (fluo) | |
| URS-FF-101 | Support the “Aperio LEICA SVS” file format (fluo) | |
| URS-FF-102 | Support the “Aperio LEICA SCN” file format (fluo) | |
| URS-FF-104 | Support the “Olympus VSI” file format (fluo) | |
| URS-FF-201 | Support the “Zeiss ZVI” file format (fluo) | |
| URS-FF-202 | Support the “Zeiss CZI” file format (fluo) | |
| URS-FF-203 | Support the “Nikon ND2” file format (fluo) | |
| URS-FF-204 | Support the “Nikon TIFF” file format (fluo) | |
| URS-FF-3005 | Support the “Aperio AFI” file format (fluo) | |
| URS-FF-3012 | Support the “Leica LIF” file format (fluo) | |
| URS-FF-3013 | Support the “Zeiss LSM” file format (fluo) | |
| URS-FF-3014 | Support the “Open Microscopy OME-TIFF” file format (fluo) | |
| URS-FF-3019 | Support the “Perkin Elmer QPTIFF” file format (fluo) | |
| URS-FF-3028 | Support the “Olympus OIR” file format (fluo) | |
| File format (z-stack) | URS-FZ-002 | Support the “3DHistech MRXS” file format (z-stack) |
| URS-FZ-100 | Support the “Hamamatsu NDPIS” file format (z-stack) | |
| URS-FZ-101 | Support the “Aperio LEICA SVS” file format (z-stack) | |
| URS-FZ-102 | Support the “Aperio LEICA SCN” file format (z-stack) | |
| URS-FZ-104 | Support the “Olympus VSI” file format (z-stack) | |
| URS-FZ-201 | Support the “Zeiss ZVI” file format (z-stack) | |
| URS-FZ-202 | Support the “Zeiss CZI” file format (z-stack) | |
| URS-FZ-203 | Support the “Nikon ND2” file format (z-stack) | |
| URS-FZ-3002 | Support the “Sakura SVSLIDE” file format (z-stack) | |
| URS-FZ-3010 | Support the “Huron Technologies TIFF” file format (z-stack) | |
| URS-FZ-3012 | Support the “Leica LIF” file format (z-stack) | |
| URS-FZ-3013 | Support the “Zeiss LSM” file format (z-stack) | |
| URS-FZ-3014 | Support the “Open Microscopy OME-TIFF” file format (z-stack) | |
| URS-FZ-3018 | Support the “Objective Imaging (Glissando)” file format (z-stack) | |
| URS-FZ-3028 | Support the “Olympus OIR” file format (z-stack) | |
| CODEC encoding [FE] | URS-FE-103 | Enable content streaming in both lossy (JPEG) and lossless (PNG) compressed file formats |
| URS-FE-2011 | Support JPEG encoding | |
| URS-FE-2012 | Support JPEG-2000 encoding | |
| URS-FE-2013 | Support JPEG-XR encoding | |
| URS-FE-2014 | Support lossless JPEG compression | |
| URS-FE-2015 | Support PNG encoding | |
| Graphical annotations [N] | URS-N-100 | Offer the option to store on-slide geometric annotations with slides |
| URS-N-2000 | Read / import “native” MRXS annotations | |
| URS-N-2001 | Read / import “native” SVS annotations | |
| URS-N-2002 | Read / import “third party” VIsiopharm MLD annotations | |
| URS-N-2003 | Read / import “third party” Indica Labs HALO ANNOTATION annotations | |
| URS-N-2004 | Read / import “third party” Definiens XML annotations | |
| URS-N-2005 | Support the creation and management of WKT-formatted annotations | |
| URS-N-2006 | Export annotations to WKT file format | |
| URS-N-2007 | Export annotations to CSV file format | |
| URS-N-2008 | Export annotations to MLD file format | |
| URS-N-2009 | Export annotations to ANNOTATION file format | |
| URS-N-2010 | Export annotations to (Aperio/Definiens) XML file format | |
| Regulatory requirements [R] | URS-R-001 | Data will be formatted to allow transfer to another system for long-term storage in a common portable format either during the life of the system or after the system is retired |
| URS-R-002 | The system will contain detection mechanisms for invalid field entries, values out of range, and blank fields if entry is required | |
| URS-R-003 | It will be possible to provide regulatory agenties with both human-readable and electronic c opies of the records, including metadata. It will be possible to transfer data in a human readable format onto transportable media such as PDF, XML, SGML. The system must allow that the copying process produces copies that preserve the content and meaning of the records | |
| URS-R-005 | The system will contain an automatically generated audit trail function for all process significant and GxP critical events and allow audit trails on tables and individual records | |
| URS-R-006 | The audit trail data will be read-only | |
| URS-R-007 | It will be impossible to disable the audit trail function | |
| URS-R-008 | The system will prevent the accidental or intentional modifications or deletion of audit trail files | |
| URS-R-009 | It will be possible to generate a report to view which data in the record has been modified | |
| URS-R-010 | A mechanism will be in place to detect and report any attempts of unauthorized use immediately to the customer | |
| URS-R-011 | The audit trail will record: user name, data and time (h/min/sec) of the event using local data and time of the host system, indication of the type of event: record creation/modification/deletion or approval, in case of modification/deletion: old value and new value, reason of change (if applicable) | |
| URS-R-012 | A specific link must be in place to trace the audit trail data to the associated electronic record(s) itself | |
| URS-R-013 | The system will not allow changes in date and time by the user | |
| URS-R-014 | The system date and time will be periodically checked and corrected. The system will support time synchronization | |
| URS-R-015 | The electronic audit trails will be readily available for review | |
| URS-R-016 | The system will be protected against unauthorized use | |
| URS-R-017 | Security will consist of at least two elements (e.g. login ID and password) in case of non-biometric security | |
| URS-R-018 | The system must enforce and automatic log-out after a defined period of no activity | |
| URS-R-019 | The system will allow the specification of different levels of access (e.g. user, administrator) | |
| URS-R-020 | The system will detect security violations and produce an alarm or warning message | |
| URS-R-021 | Controls will be in place to ensure that no two (2) individuals can have the same combination of identification code and password | |
| URS-R-022 | If a password is not issued privately (i.e. the password issuer knows the password), the user will immediately reset their password | |
| Documentation requirements | URS-D-001 | A user guide (manual) is available |
| URS-D-100 | User requirements are available | |
| URS-D-101 | Installation manual is available | |
| URS-D-2001 | Back-end programming (API) documentation is available | |
| URS-D-2002 | Front-end programming (PMA.UI / JavaScript) documentation is available | |
| Requirements (non-specific) | URS-001 | It’s possible to view slides through the slide management module. |
| URS-003 | It’s possible to add users. | |
| URS-004 | Only administrator users have access to the slide management module. | |
| URS-005 | An undeletable administrator account is configured | |
| URS-006 | The following user information can be recorded: first name, last name, login name, password and e-mail. | |
| URS-007 | Users that are created in the slide management module get access to the viewing module. | |
| URS-008 | Users can be given administrator rights. | |
| URS-009 | Users can be suspended. As long as users are suspended, they do not have access to the software. | |
| URS-010 | Raw server log files can be consulted by administrators (read only). | |
| URS-011 | A list of users currently logged in (active session) is available. Active sessions can be terminated. | |
| URS-012 | Users can quickly access the user manual | |
| URS-013 | Users can log out | |
| URS-101 | Offer the option to store form-based annotations with slides | |
| URS-102 | Present a report with operating characteristics to assist in on-site installation troubleshooting | |
| URS-3000 | Form template definitions can be imported and exported | |
| URS-3001 | Users can be granted or denied access to specific directories | |
| API | URS-A-250 | Method to identify the version / revision of PMA.core running |
| URS-A-251 | Method(s) to request licensing information from a distance | |
| URS-A-252 | Method to authenticate users and generate sessionID variables | |
| URS-A-253 | Method to de-authenticate an active sessionID | |
| URS-A-254 | Method to determine whether a user can make annotations | |
| URS-A-255 | Method to retrieve root-directories | |
| URS-A-256 | Method to check if the server is responsive. Typically this is done through a server “ping”, but in productions environments this service is often disabled to prevent opportunistic phishing attempts. | |
| URS-A-257 | Method to get an overview of all available root-directories. | |
| URS-A-258 | Method to retrieve sub-directories from a parent directory | |
| URS-A-259 | Method to retrieve hosted slides in a specific directory | |
| URS-A-260 | Method to retrieve an anonymized string identification sequence representing a hosted slide | |
| URS-A-261 | Method to retrieve information about a hosted slide | |
| URS-A-262 | Methods to retrieve on-slide annotations | |
| URS-A-263 | Methods to manipulate on-slide annotations | |
| URS-A-264 | Method to obtain an on-slide annotation’s circumference (distance for 1D-objects) | |
| URS-A-265 | Method to obtain an on-slide annotation’s surface (only for 2D-objects) | |
| URS-A-266 | Method to query available form templates | |
| URS-A-267 | Methods to retrieve slide-associated filled-out forms | |
| URS-A-268 | Methods to manipulate slide-associated form data | |
| URS-A-269 | Method(s) to change user passwords | |
| URS-A-270 | Method to map a UID back to its real path reference | |
| URS-A-271 | Method to map a root-directory virtual path to its physical presence on the hard disk | |
| URS-A-350 | Method to obtain a unique identifier of a slide based on its contents | |
| URS-A-351 | Method to search for slides | |
| URS-A-352 | Method to create directories that requires administrator privileges | |
| URS-A-353 | Method to delete directories that requires administrator privileges | |
| URS-A-354 | Method to create users that requires administrator privileges | |
| URS-A-355 | Method to move slides that requires administrator privileges | |
| URS-A-356 | Method to rename slides that requires administrator privileges | |
| URS-A-357 | Method to rename directories that requires administrator privileges | |
| URS-A-358 | Method to export annotations in Visiopharm MLD, Halo XML and Well Known Text formats | |
| URS-A-359 | Method to reset a user’s password | |
| URS-A-360 | Method to remind a user’s password | |
| URS-A-361 | Method to list all users that requires administrator privileges | |
| URS-A-362 | Method to suspend a user that requires administrator privileges | |
| URS-A-363 | Method to obtain user information for a session ID that requires administrator privileges | |
| URS-A-2000 | Methods to programmatically (and transaction-based) upload a slide | |
| URS-A-2002 | Methods to programmatically (and transaction-based) download a slide | |
| PMA.UI framework | URS-U-200 | A javascript viewport for whole slide images (WSI) is offered |
| URS-U-201 | A javascript gallery control for whole slide images (WSI) is offered | |
| URS-U-202 | A javascript treeview control for whole slide images (WSI) is offered | |
| URS-U-210 | The viewport retrieves tiles from PMA.core as needed | |
| URS-U-300 | The viewport offers a configurable overview widget | |
| URS-U-301 | The viewport offers a configurable dimensions control widget | |
| URS-U-302 | The viewport offers a configurable barcode widget | |
| URS-U-303 | The viewport offers a configurable rotation widget | |
| URS-U-304 | The viewport offers a configurable filename widget | |
| URS-U-305 | The viewport offers a configurable scalebar widget | |
| URS-U-306 | The viewport offers a configurable scapshot button widget | |
| URS-U-307 | The viewport offers a configurable color adjustment widget | |
| URS-U-308 | The viewport offers a configurable zoom slider widget | |
| URS-U-309 | The viewport offers configurable themes (layout) | |
| URS-U-310 | The viewport offers configurable digital zoom levels | |
| URS-U-320 | The viewport offers realtime distance measurements | |
| URS-U-321 | The viewport offers realtime area measurements | |
| URS-U-322 | Realtime measurements can handle dimensionless (no ppm indication) image data | |
| URS-U-340 | The gallery control can toggle between thumbnail and label view | |
| URS-U-341 | The gallery control offers “lazy loading” | |
| URS-U-342 | The gallery control retrieves image data at the correct resolution (no client-side rescaling implied) | |
| URS-U-360 | The tree control offers “lazy loading” | |
| URS-U-380 | Make rectangular annotations | |
| URS-U-381 | Make eliptical annotations | |
| URS-U-382 | Make freehand annotations | |
| URS-U-383 | Make landmark annotations | |
| URS-U-384 | Make polygon annotations | |
| URS-U-385 | Erase parts of an annotation | |
| URS-U-386 | Change the style of an annotation (line, fill, opacity) | |
| URS-U-387 | Make line annotations |
Looking for one of our original features that you think should be included in this table? Contact us!
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