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Validated Digital Pathology Systems (DPS), includes IT infrastructure, Image acquisition software, image viewing software and/or image analysis software etc. When these are being removed from service, all of them will need to go through decommissioning activities as well the facility personnel performing the decommissioning responsibilities. In addition, when WSI (whole slide imaging) & WSS (whole slide scanning) systems are being upgraded and for which the replacement technology does not permit the use or retrieval of data in the new version, they will need to go through decommissioning phases as well.
Overall, the data must remain accessible and readable once the hardware/software system is no longer part of the workflow process. A formal retirement or decommissioning plan should be initiated and completed.
A system decommissioning plan (DP) should address the following topics:
- Purpose, and scope incl. description of the hardware/software
- Responsibilities of the multidisciplinary stakeholders incl. system administration (SA), global system validation quality assurance (GSVQA), Archivist, Information technology (IT), Management, and Decommissioning Project Team if applicable.
- The DP procedures include:
o the Initiation of the change control with the evaluation of the potential affects to related technologies. Risk assessment should indicate how interfacing systems would be decoupled and how the workflow would be re-established.
o The disposition of data from a decommissioned system can be achieved by the ability to retrieve archived records (data migration) or by archiving the system related records (archiving). In this latter case, it seems crucial to know the availability of support throughout the retention period. Additional components could be necessary to archive as well in order to facilitate its retrieval in a later phase.
o Documentation necessary to be archived as well includes eg. user ID’s, passwords, media, manuals, vendor documentation and/or procedures for the system operation and support including training materials, etc…
Before issuing the decommissioning summary report (DSR), it’s important to verify that the minimum acceptance criteria are met:
- All relevant data has been successfully archived and has been demonstrated to be readily retrievable. If any discrepancies or deviations have been reviewed and approved, they appear within the DSR.
- The impact to any related technologies has been addressed as necessary
- All relevant system documentation has been archived
- Hardware/Software and peripherals have been dispositioned.
The final DSR will summarize all the activities and testing related to the decommissioning: scope, results, generated documentation, location of archive, revision of the acceptance criteria and the decommissioning memo (DM).