1.3.1 General functions
1.3.1 General functions
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Requirement code
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Requirement # and requirement
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Y
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1.3.100 The system offers non-SDMS trained personnel the ability to easily access system data via an intuitive, user-friendly Windows-type graphical user interface (GUI) which permits the display of stored data.
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Response:
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Users can easily access stored data without downloading it via the Document Details page.[43]
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Y
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1.3.101 The system allows authorized users to configure their GUI to a specific language, character set, and time zone.
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Response:
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The software allows users to change the language at the log-in screen, and additional language packs can be added with language packs.[44] The time zone can be set as a system-wide property.
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U
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1.3.102 The system permits remote access for users, system admins, and support agents.
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Response:
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The system can be accessed from anywhere using a valid web browser. It's not clear if the webLiMS-hosted SDMS can be accessed via the Alfresco Mobile application. (See 1.1.201)
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U
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1.3.103 The system allows for the use of navigation keys to freely move from field to field.
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Response:
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It's not clear if keyboard shortcuts or tabbing are inherent to the interface.
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Y
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1.3.104 The system allows tabular data to be sorted and filtered.
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Response:
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This feature was added in version 4.2.[45]
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N
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1.3.105 The system can send on-screen output to a printer or file without contradicting read-only statuses.
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Response:
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As read-only statuses don't seem to be supported, this functionality is not available by extension.[41]
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U
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1.3.106 The system contains one or more spell-check dictionaries that allow authorized users to add, edit, or remove entries.
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Response:
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The SDMS seems to have some minor spell check abilities in the search box, but it's not clear if users can edit the dictionary.[46] Additionally, it's not clear if spell check can be employed during inline editing of documents.
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Y
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1.3.107 The system uses human-readable metadata tags to better describe, index, and store all captured and archived data.
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Response:
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Metadata extraction occurs automatically via extractors, which can be configured.[47]
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N
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1.3.108 The system can generate metadata tags via derived value rules.
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Response:
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That functionality is not supported.
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N
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1.3.109 The system allows users to manually add metadata tags to files.
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Response:
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The system appears to not allow users to add/edit metadata after upload without major customization.[48]
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Y
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1.3.110 The system provides full metadata, keyword, and field search capability, including the use of multiple search criteria.
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Response:
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The system allows users to search based on numerous facets like file type, creator, creation date, etc.[49]
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U
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1.3.111 The system allows users to search for similar records based upon a set of metadata tag values.
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Response:
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It's not clear if the latest version includes this advanced search capability. The assumption is it doesn't.
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U
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1.3.112 The system allows users to build, save, and edit queries for future use.
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Response:
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It's not clear if the latest version includes this advanced search capability. The assumption is it doesn't.
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N
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1.3.113 The system can automate the search for and extraction of pertinent data, including the export of that data to external applications for additional processing and calculation.
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Response:
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The system doesn't appear to have this functionality.
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Y
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1.3.114 The system allows users to attach comments to data and files.
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Response:
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Users can add, edit, or delete comments, based upon their role.[50]
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U
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1.3.115 The system's file viewer/explorer allow users to view native, processed, and archived data in its native file structure.
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Response:
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Complete folder-based file structures can be imported into Alfresco Community[51], but the documentation doesn't explicitly state if that file structure can be viewed in the file viewer.
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N
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1.3.116 The system can link objects to other objects, e.g. linking a standard operating procedure (SOP) to a test result.
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Response:
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Users appear able to place a link to a different file in the comments of an existing file[52]; however, no file linking mechanism seems to exist.
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N
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1.3.117 The system notifies users of events like the scheduling and completion of tasks.
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Response:
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Users can receive e-mail notifications of a few system-wide changes[53], but many other notifications like event reminders and new/modified post reminders must be manually programmed into the existing code.[54][55]
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1.3.118 The system includes the ability to set up alerts via email.
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Response:
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1.3.119 The system offers integrated or online user help screens.
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Response:
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1.3.120 The system includes data analysis and calculation tools.
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Response:
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1.3.2 Configuration and customization
1.3.2 Configuration and customization
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Requirement code
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Requirement # and requirement
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1.3.200 The system architecture is modular or extensible and can easily and efficiently be modified to facilitate the addition of new functionality as business needs change.
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Response:
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1.3.201 The system has an application programming interface (API) or a similar software development toolkit (SDK). If web-based, the API should support Simple Object Access Protocol (SOAP), representational state transfer (REST), or both.
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Response:
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1.3.202 The system allows a user to independently add fields without requiring reconfiguration of the system, even after routine upgrades and maintenance.
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Response:
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1.3.203 The system allows for the integration of additional printers and scanners both locally and externally.
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Response:
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1.3.3 Data capture
1.3.3 Data capture
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Requirement code
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Requirement # and requirement
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1.3.300 The system can manage and store both sample- and non-sample-related data, including images from microscopes, GCMS scans of peaks, PDF files, spreadsheets, or even raw data files from instrument runs for later processing.
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Response:
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1.3.301 The system can manage and store media objects like digital photos, bitmaps, movies, and audio files.
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Response:
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1.3.302 The system allows multiple native instruments and users to enter data into the system simultaneously without disruption.
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Response:
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1.3.303 The system can interface with and import existing data from other databases and file shares.
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Response:
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1.3.304 The system supports data capture from a Citrix-based environment.
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Response:
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1.3.305 The system allows file indexes to be stored centrally while associated files are stored geographically.
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Response:
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1.3.306 The system allows users to organize captured data by project, date, location, instrument, etc.
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Response:
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1.3.307 The system can route captured data based upon specified metadata tags.
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Response:
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1.3.308 The system allows full on-screen review and approval of native instrument data prior to database commitment.
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Response:
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1.3.309 The system keeps all captured data and its format intact and captures modifications of that data as a version, including date and time of those modifications, for regulatory purposes.
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Response:
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1.3.310 The system has a tool that allows users to capture data printed to it as a searchable PDF file.
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Response:
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1.3.311 The system can automatically normalize and store incoming data to a technology-neutral format like XML.
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Response:
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1.3.312 The system allows incoming and entered files to be converted into other open formats like JCAMP-DX, TraML, mzML, mzXML, AnIML, pepXML, and protXML.
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Response:
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1.3.313 The system can capture and store native instrument and processed data based on a scheduled time or a real-time event, such as upon file creation.
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Response:
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1.3.314 The system allows users to manually upload instrument data files that are not part of a scheduled upload.
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Response:
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1.3.315 The system allows for the specification of a retention period for captured native instrument and processed data and can enact it based on date-based metadata fields or a future event.
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Response:
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1.3.316 The system can remove data from client machines upon upload and/or backup, based on a schedule or retention policy.
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Response:
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1.3.317 The system allows users to review, restore, and reprocess original native instrument data on the original instrument acquisition software.
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Response:
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1.3.318 The system allows users to open and view captured native instrument files without restoring them.
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Response:
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1.3.319 The system allows captured processed data to be reused by other applications without having to reprocess it.
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Response:
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1.3.320 The system provides a method to extract data points from captured processed data and present it in a human-readable format.
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Response:
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1.3.321 The system can parse captured data files containing specified metadata into a live results table.
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Response:
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1.3.4 Data archiving and migration
1.3.4 Data archiving and migration
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Requirement code
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Requirement # and requirement
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1.3.400 The system provides data archiving functionality for all contained data, without requiring an off-line mode.
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Response:
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1.3.401 The system allows for a configurable scheduled archive, not requiring human interaction with the data to be archived.
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Response:
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1.3.402 The system allows for a scheduled archive of data directly captured from a specific native instrument.
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Response:
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1.3.403 The system permits native instrument data to be archived and restored with its original directory structure.
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Response:
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1.3.404 The system allows for the specification of a retention period for archived and migrated data and can enact it based on date-based metadata fields or a future event.
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Response:
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1.3.405 The system ensures that held or locked native instrument data not captured during a scheduled archive will be captured during the next scheduled archive.
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Response:
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1.3.406 The system can perform archive and restore functions simultaneously with data capture and viewing functions, without disruption.
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Response:
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1.3.407 The system allows native instrument and processed data migrated from an old SDMS version to be backed up and restored without alteration.
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Response:
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1.3.5 Instruments
1.3.5 Instruments
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Requirement code
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Requirement # and requirement
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1.3.500 The system bilaterally interfaces with instruments and related software based on the Unix and Windows platforms.
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Response:
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1.3.501 The system can download data directly from laboratory instruments.
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Response:
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1.3.502 The system can track and report on the usage of attached laboratory instruments.
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Response:
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1.3.503 The system can automatically (or manually allow an authorized user to) remove an instrument from potential use when it falls out of tolerance limit or requires scheduled calibration.
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Response:
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1.3.504 The system maintains a reportable database of preventative maintenance, calibration, and repair records for attached laboratory instruments.
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Response:
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1.3.505 The system can schedule calibration, verification, and maintenance tasks on attached instruments and make that schedule available for viewing.
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Response:
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1.3.506 The system allows users to create and edit instrument maintenance profiles.
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Response:
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1.3.6 External system interfaces
1.3.6 External system interfaces
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Requirement code
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Requirement # and requirement
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1.3.600. The system supports a library of common electronic data deliverable (EDD) formats.
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Response:
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1.3.601 The system can transfer data to and from other record management systems.
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Response:
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1.3.602 The system integrates with Microsoft Exchange services.
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Response:
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1.3.603 The system can import data from and export data to Microsoft Word, Excel, Access, and/or Powerpoint.
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Response:
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1.3.604 The system can interface with non-Microsoft programs.
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Response:
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1.3.605 The system can interface with enterprise resource planning (ERP) systems.
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Response:
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1.3.606 The system can interface with internal and external laboratory systems like laboratory information management systems (LIMS) and electronic laboratory notebooks (ELNs).
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Response:
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1.3.607 The system can leverage the application programming interface (API) of other systems to establish integration between systems.
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Response:
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1.3.608 The system provides a real-time interface for viewing live and stored data transactions and errors generated by interfaced instruments and systems.
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Response:
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1.3.609 The system supports dockable mobile devices and handles information exchange between them and the system.
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Response:
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1.3.610 The system supports the use of optical character recognition (OCR) software.
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Response:
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1.3.7 Reporting
1.3.7 Reporting
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Requirement code
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Requirement # and requirement
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1.3.700 The system includes a versatile report writer and forms generator that can generate reports from any data in the system.
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Response:
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1.3.701 The system can interface with a third-party reporting application.
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Response:
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1.3.702 The system allows the development of custom templates for different types of reports.
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Response:
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1.3.703 The system maintains template versions and renditions, allowing management and tracking of the template over time.
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Response:
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1.3.704 The system uses Microsoft Office tools for formatting reports.
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Response:
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1.3.705 The system provides multiple ways to visualize data in reports, including graphs, trend bars, pie charts, spectrum, etc. for the purpose of presenting information and identifying trends.
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Response:
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1.3.706 The system makes graphic and tabular data vector-scalable in reports.
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Response:
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1.3.707 The system allows for internal hyperlinking to source data in reports.
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Response:
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1.3.708 The system allows users to manually adjust inaccurate data parsing routines for reports.
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Response:
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1.3.709 The system can indicate whether a report is preliminary, amended, corrected, or final while retaining revision history.
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Response:
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1.3.710 The system can automatically generate laboratory reports of findings and other written documents.
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Response:
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1.3.711 The system provides an ad-hoc web reporting interface to report on user-selected criteria.
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Response:
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1.3.712 The system can automatically generate and post periodic static summary reports on an internal web server.
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Response:
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1.3.713 The system can transmit reports in a variety of ways including fax, e-mail, print, and website in formats like RTF, PDF, HTML, XML, DOC, XLS, and TXT.
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Response:
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1.3.714 The system supports PDF/A, an ISO-standardized version of the Portable Document Format (PDF).
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Response:
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1.3.715 The system includes a rules engine to determine the recipients of reports and other documents based on definable parameters.
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Response:
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1.3.716 The system provides printer-friendly audit trails for cleaner reporting of audit data.
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Response:
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1.3.717 The system provides an interface for external clients to search, generate, and view processed data reports based on metadata tags.
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Response:
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1.3.718 The system provides document workflow management tools for streamlining their creation, review, modification, and approval.
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Response:
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