User:Shawndouglas/sandbox/sublevel3

Sandbox begins below

• Y: Meets requirement in commercial off-the-shelf solution as delivered/configured (or vendor provides service)
• YC: Meets requirement only with customization (additional code, using a third-party application, etc.)
• N: Does not meet requirement
• I: Informational response only, N/A
• U: Unknown

1.0 Demonstration

1.0 Demonstration Requirement code Requirement # and requirement N 1.0.000 The system can be tried via an online and/or on-site demonstration. Response: The developers do not seem to host an online demo of Alfresco Community Edition.

1.1 Information technology

1.1.1 General IT 1.1.1 General IT Requirement code Requirement # and requirement I 1.1.100 The system operates with a traditional client-server architecture, with software installed on each machine that needs to access the system. Response: Alfresco uses client-server technology, though the client is web-based. See 1.1.101. Y 1.1.101 The system operates with a web-based interface, hosted on a server and accessed via a web browser on most any machine. Response: Alfresco operates with a content application server, while users connect to it via web, mobile, and other types of clients. As Alfresco is integrated into the webLiMS suite of applications, the content application server is hosted in the cloud. Y 1.1.102 The system contains a single, centralized database that supports multiple sites and departments. Response: Alfresco's content repository "is comparable to a database, except that it holds more than data." The development team describes this further in their documentation: The actual binary streams of the content are stored in files managed in the repository, although these files are for internal use only and do not reflect what you might see through the shared drive interfaces. The repository also holds the associations among content items, classifications, and the folder/file structure. The folder/file structure is maintained in the database and is not reflected in the internal file storage structure. Alfresco also allows users to set up "sites" for separate projects or user groups to manage custom content. Y 1.1.103 The system's database conforms to the Open Database Connectivity Standard (ODBC). Response: Alfresco Community comes bundled with PostgreSQL, which has an associated ODBC driver. The software can also be run against MySQL. Y 1.1.104 The system is designed so upgrades to the back-end database do not require extensive reconfiguration or effectively cripple the system. Response: Alfresco Community allows administrators to extend and override database properties through repository configuration files, presumably with little impact to the system. Y 1.1.105 The system is designed to not be impacted by multiple users or failover processes. Response: One of the guiding design principles of Alfresco Community is to be enterprise scalable. This aspect was so important that the developers created a Scalability Blueprint. Y 1.1.106 The system applies security features to all system files. Response: Alfresco Community system files, including configuration files, are only accessible to authorized administrators. Y 1.1.107 The system applies log-in security to all servers and workstations accessing it. Response: Users must provide a username and password before entering the system via web client. Administrators must also use a username and password to access server-side files. All of this accomplished through the authentication subsystem. Y 1.1.108 The system provides a workstation and server authentication mechanism. Response: Alfresco Community employs an authentication subsystem to ensure authentication between client and server. U 1.1.109 The system applies Secured Socket Layer (SSL) encryption on the web client interface. Response: Alfresco Community seems to be able to be used in HTTPS mode with some configuration, but it's not clear if it interfaces via HTTPS in default mode. Some documentation and forum posts suggest it's possible for the client to access the server via SSL. U 1.1.110 The system encrypts client passwords in a database, with support for multi-case and special characters. Response: Alfresco Community does not seem to inherently include encryption capabilities, at least for repositories. The documentation for Community makes no mention of encryption on passwords. Several items seem to support the lack of encryption, though this matter needs to be researched further. Y 1.1.111 The system uses TCP/IP as its network transport. Response: Data can be transferred between client and server via FTP and HTTP high-level application protocols (among others). Y 1.1.112 The system allows automated backup and restore capability without support intervention, as well as manual backups. Response: Alfresco Community allows for manual backup and restore by the administrator. Further backup and recovery tools can be added with the Alfresco BART add-on. U 1.1.113 The system maintains the transactional history of system administrators. Response: It's not clear if an audit log is maintained of all administrator activity. 1.1.2 Hardware environment 1.1.2 Hardware environment Requirement code Requirement # and requirement Y 1.1.200 The system proves compatible with a variety of hardware environments. Response: The developers state "Alfresco degrades gracefully on low powered hardware, and small installations can run well on any modern server." They also state the optimal hardware configuration. U 1.1.201 The system can be utilized with a touch-screen. Response: Alfresco Community can normally be accessed via the Alfresco Mobile application for Android and iPhone. It's not clear if webLiMS users will be able to access their cloud-hosted SDMS using the mobile app, however. 1.1.3 Software environment 1.1.3 Software environment Requirement code Requirement # and requirement Y 1.1.300 The system proves compatible with a variety of software environments. Response: Alfresco Community installation packages exist for Windows, Mac, and Linux. Y 1.1.301 The system utilizes a non-proprietary database such as Oracle or Microsoft SQL Server. Response: Alfresco Community comes bundled with PostgreSQL and can also be run against MySQL.

1.2 Regulatory compliance and security

1.2.1 Regulatory compliance 1.2.1 Regulatory compliance Requirement code Requirement # and requirement Y 1.2.100 The system can generate accurate and complete copies of records in both a human-readable and original electronic format for review and copying. Response: Alfresco Community remains "format-agnostic," meaning any file type can be uploaded. As long as the original file's MIME type allows for indexing, thumbnailing, metadata extraction, etc., the file will be human-readable while maintaining the original electronic format. Review and copy of the file is permission-based. U 1.2.101 The system supports 21 CFR Part 11 and EU Annex 11 requirements, including log-in security, settable automatic logouts, periodic requirements for mandatory password changes, limits on reusability of passwords, and full electronic signature. Response: Alfresco Community seems to support many 21 CFR Part 11 requirements. The inherent lack of digital signatures, however, has been referenced on multiple occasions on the Alfresco site over the years. Are the add-ons enough? The same problem likely exists for EU Annex 11 requirements. N 1.2.102 The system supports USP <232>/<233> requirements. Response: Alfresco Community does not support these requirements. U 1.2.103 The system supports GALP and/or GAMP standards. Response: Alfresco Community seems to support some GxP requirements; however, it's not clear if all requirements are met. Users can add digital signatures to PDFs via an add-on, but it's not clear if other non-PDF records can be digitally signed, for example. Y 1.2.104 The system supports the U.S. DoD 5015.2 Standard. Response: Through the Records Management module, the Records Management Site can be set up to be DoD 5015.2 Standard compliant. Y 1.2.105 The system maintains date- and time-stamped audit trails of all data manipulation — such as changes to results, data analysis parameters, and methods — as consistent with all applicable regulations and standards, making the information available for review, copying, and reporting to authorized users. Response: As long as content auditing is enabled via configuration, reportable audit trails will be captured. The documentation states: The audit log contains the entire history of an object since the point it was added to the File Plan, and can be useful for finding out about specific events that have occurred during an objects life cycle, and any users that have been involved. Every entry in the audit log is timestamped and where metadata has been changed, the original values and changed values are recorded. U 1.2.106 The system audit log retains all data, prohibits any deletions, and allows user comments. Response: As stated in 1.2.105, the entire history of an object is retained. Access to view, export, or file the audit trail as a a record is allowed if the administrator assigns the "Access Audit" permission. It's not explicitly stated whether or not the user can delete any audit content. If the audit log is filed as a record, then those with access to that record can comment on it. It's not explicitly clear if a non-filed audit log can be commented on. Y 1.2.107 The system maintains audit trails at least as long as the records to which they pertain. Response: As stated in 1.2.105, the entire history of an object is retained. Additionally, disposition schedules allow associated metadata and an audit trail to remain even after deletion as long as "Maintain Record Metadata after Delete" is enabled during the creation of a disposition schedule. Audit trails for held content are also maintained. Y 1.2.108 The system provides additional persistent auditing capabilities, such as the audit of cancelled uploads and scheduled system functions. Response: The Audit Filter can be customized to include additional auditing of system and more complex user tasks. U 1.2.109 The system provides the ability to both automatically and manually add secure electronic signatures to documents and other data. Response: See response in 1.2.101 and 1.2.103. N 1.2.110 The system can automatically validate and approve data prior to being moved to the main database. Response: The SDMS doesn't seem to inherently have automated data validation and approval tools. Users who file records will need to manually validate that metadata has been captured from the added record and mark the record as complete before it is filed. 1.2.2 Security 1.2.2 Security Requirement code Requirement # and requirement Y 1.2.200 The system allows administrators and other authorized users to configure multiple levels of user rights and security by site location, department, group, role, and/or specific function. Response: The SDMS allows for four types of roles out of the box, each with their own assigned permissions. More flexible security roles and groups can be added by either setting up custom roles on a clean install or installing security add-ons. U 1.2.201 The system allows administrators and users to reset user passwords. Response: Alfresco Community doesn't seem to make it easy. An administrator can change the admin password, and users are allowed to reset their password in their dashboard and with the addition of the Reset Password Dialog add-on. But it's not clear if administrators can change user passwords without knowing the original user password. N 1.2.202 The system features and enforces adjustable rules concerning password complexity, reuse, and expiration. Response: The software does not have this functionality by default. (A commercial add-on may provide this functionality.) N 1.2.203 The system can lock a user out after a specified number of consecutive failed log-in attempts. Response: The software does not have this functionality by default. (A commercial add-on may provide this functionality.) N 1.2.204 The system provides the option for automatic user logout based on keyboard or mouse inactivity. Response: The software doesn't appear to have this functionality. Y 1.2.205 The system makes authority checks to ensure only authorized individuals can use the system to perform an operation. Response: The system contains configurable authorization enforcement. Y 1.2.206 The system allows authorized users to modify records, while also maintaining an audit trail of such actions. Response: Users can view, edit, delete, and download files. As long as content auditing is enabled via configuration, reportable audit trails will be captured. Y 1.2.207 The system allows authorized users to manually delete records, while also maintaining an audit trail of such actions. Response: Records can manually be deleted while retaining an audit trail as long as auditing is enabled via configuration. Records can also be deleted automatically as part of a disposition schedule in the Records Management module. Associated metadata and an audit trail will remain as long as "Maintain Record Metadata after Delete" is enabled during the creation of a disposition schedule. N 1.2.208 The system prompts users to declare a reason for making changes to or deleting data in the system. Response: The software doesn't appear to have this functionality. Y 1.2.209 The system allows authorized users to generate a detailed user access record. Response: As long as content auditing is enabled via configuration, authorized users can view reportable audit trails which include user access records. N 1.2.210 The system provides email notification of lockout, security access, and improper workstation access. Response: The software doesn't appear to have this functionality. N 1.2.211 The system provides a mechanism to allow a user read-only access to stored data. Response: The software doesn't appear to have this functionality. Y 1.2.212 The system allows automatic and/or manual holds or locks to be placed on data to ensure it goes unaltered or remains retrievable during a retention period. Response: Through the Records Management module, users can manually set up holds with user permissions and apply records or folders to the hold. U 1.2.213 The system can first feed data from connected non-CFR-compliant instruments through a virtual environment that is compliant (audit trailed, secure, versioned, etc.) before being stored. Response: Not clear if information can be fed into webLiMS, be made complaint, and then stored in the SDMS. N 1.2.214 The system can control whether users are able to export data to portable long-term storage media like a USB flash drive or recordable DVD. Response: The software doesn't appear to have this functionality. U 1.2.215 The system employs automatic file encryption on stored data. Response: Alfresco Community does not seem to inherently include encryption capabilities, at least for repositories. Several items seem to support the lack of encryption, though this matter needs to be researched further.

1.3 General system functions

1.3.1 General functions 1.3.1 General functions Requirement code Requirement # and requirement Y 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. Response: Users can easily access stored data without downloading it via the Document Details page. Y 1.3.101 The system allows authorized users to configure their GUI to a specific language, character set, and time zone. Response: The software allows users to change the language at the log-in screen, and additional language packs can be added with language packs. The time zone can be set as a system-wide property. U 1.3.102 The system permits remote access for users, system admins, and support agents. Response: 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) U 1.3.103 The system allows for the use of navigation keys to freely move from field to field. Response: It's not clear if keyboard shortcuts or tabbing are inherent to the interface. Y 1.3.104 The system allows tabular data to be sorted and filtered. Response: This feature was added in version 4.2. N 1.3.105 The system can send on-screen output to a printer or file without contradicting read-only statuses. Response: As read-only statuses don't seem to be supported, this functionality is not available by extension. U 1.3.106 The system contains one or more spell-check dictionaries that allow authorized users to add, edit, or remove entries. Response: 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. Additionally, it's not clear if spell check can be employed during inline editing of documents. Y 1.3.107 The system uses human-readable metadata tags to better describe, index, and store all captured and archived data. Response: Metadata extraction occurs automatically via extractors, which can be configured. N 1.3.108 The system can generate metadata tags via derived value rules. Response: That functionality is not supported. N 1.3.109 The system allows users to manually add metadata tags to files. Response: The system appears to not allow users to add/edit metadata after upload without major customization. Y 1.3.110 The system provides full metadata, keyword, and field search capability, including the use of multiple search criteria. Response: The system allows users to search based on numerous facets like file type, creator, creation date, etc. U 1.3.111 The system allows users to search for similar records based upon a set of metadata tag values. Response: It's not clear if the latest version includes this advanced search capability. The assumption is it doesn't. U 1.3.112 The system allows users to build, save, and edit queries for future use. Response: It's not clear if the latest version includes this advanced search capability. The assumption is it doesn't. N 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. Response: The system doesn't appear to have this functionality. Y 1.3.114 The system allows users to attach comments to data and files. Response: Users can add, edit, or delete comments, based upon their role. U 1.3.115 The system's file viewer/explorer allow users to view native, processed, and archived data in its native file structure. Response: Complete folder-based file structures can be imported into Alfresco Community, but the documentation doesn't explicitly state if that file structure can be viewed in the file viewer. N 1.3.116 The system can link objects to other objects, e.g. linking a standard operating procedure (SOP) to a test result. Response: Users appear able to place a link to a different file in the comments of an existing file; however, no file linking mechanism seems to exist. N 1.3.117 The system notifies users of events like the scheduling and completion of tasks. Response: Users can receive e-mail notifications of a few system-wide changes, but many other notifications like event reminders and new/modified post reminders must be manually programmed into the existing code. Y 1.3.118 The system includes the ability to set up alerts via email. Response: Users can receive e-mail notifications of a few system-wide changes. N 1.3.119 The system offers integrated or online user help screens. Response: Help screens don't appear to be integrated into Alfresco Community, but documentation on the system can be found on the Alfresco website. N 1.3.120 The system includes data analysis and calculation tools. Response: Alfresco Community does not include data analysis or calculation tools; however, those tools can be found in other webLiMS applications. 1.3.2 Configuration and customization 1.3.2 Configuration and customization Requirement code Requirement # and requirement Y 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. Response: One of the guiding design principles of Alfresco Community is to be enterprise scalable. Users can add additional functionality through the add-ons community. Y 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. Response: Alfresco Community can be extended with the Maven Alfresco SDK or numerous APIs. N 1.3.202 The system allows a user to independently add fields without requiring reconfiguration of the system, even after routine upgrades and maintenance. Response: Custom fields are not able to be added by users. Custom Content Models allow administrators to add new metadata fields on the back end, however. N 1.3.203 The system allows for the integration of additional printers and scanners both locally and externally. Response: Alfresco Community does not inherently support printers. However, the interface is web-based, and an accessed file can be downloaded and printed to a local machine. 1.3.3 Data capture 1.3.3 Data capture Requirement code Requirement # and requirement Y 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. Response: Alfresco Community remains "format-agnostic," meaning any file type can be uploaded. Y 1.3.301 The system can manage and store media objects like digital photos, bitmaps, movies, and audio files. Response: Alfresco Community remains "format-agnostic," meaning any file type can be uploaded, including media files. Y 1.3.302 The system allows multiple native instruments and users to enter data into the system simultaneously without disruption. Response: One of the guiding design principles of Alfresco Community is to be enterprise scalable, with as few disruptions as possible. Note that instruments can't be connected directly to the SDMS; however, instruments can be interfaced to the SDMS through the LabVia webLiMS application. U 1.3.303 The system can interface with and import existing data from other databases and file shares. Response: Complete folder-based file structures can be imported into Alfresco Community using a number of methods. It's assumed webLiMS users can also move files from other webLiMS applications to the SDMS, but this needs to be confirmed. N 1.3.304 The system supports data capture from a Citrix-based environment. Response: Aside from capturing metadata data from imported files of a sufficient MIME type, Alfresco Community doesn't seem to offer data capture capabilities. However, other webLiMS applications can capture instrument and other data, and that data can then be managed and stored in the SDMS. Y 1.3.305 The system allows file indexes to be stored centrally while associated files are stored geographically. Response: Alfresco Community uses Solr for indexing, and it has "no need to duplicate indexes on every machine in a cluster," suggesting indexes could be stored on a central machine. N 1.3.306 The system allows users to organize captured data by project, date, location, instrument, etc. Response: Aside from capturing metadata data from imported files of a sufficient MIME type, Alfresco Community doesn't seem to offer data capture capabilities. However, users can import files and organize them into folders based on specific criteria. N 1.3.307 The system can route captured data based upon specified metadata tags. Response: Alfresco Community doesn't seem to offer data capture capabilities. Imported files will have metadata captured if it's of a certain MIME type; however, those files aren't able to be routed into specific repository folders based on metadata information. N 1.3.308 The system allows full on-screen review and approval of native instrument data prior to database commitment. Response: Alfresco Community can not interface with instruments and does not have this functionality. However, optional middleware could add this functionality. N 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. Response: Alfresco Community doesn't seem to offer data capture capabilities. However, files imported into the SDMS will retain their format, and an audit trail will keep track of all changes to it for regulatory purposes. N 1.3.310 The system has a tool that allows users to capture data printed to it as a searchable PDF file. Response: Alfresco Community doesn't seem to offer data capture capabilities. Using the standard transform options of the software, users can convert some files formats to a searchable PDF format. N 1.3.311 The system can automatically normalize and store incoming data to a technology-neutral format like XML. Response: Alfresco Community does allow certain text-based formats like RTF, PDF, DOC, etc. to be converted to XML via transform tools, but it doesn't seem to be a process that can be automated without revisions to the software. N 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. Response: Alfresco Community does not seem to support conversion of files to these formats. N 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. Response: Alfresco Community doesn't seem to offer data capture capabilities, nor can in directly interface with instruments. Other applications in the webLiMS suite or optional middleware may be able to schedule instrument and processed data captures. Y 1.3.314 The system allows users to manually upload instrument data files that are not part of a scheduled upload. Response: Alfresco Community remains "format-agnostic," meaning any file type can be uploaded. As long as the instrument data files are moved off the instrument to a media that can be accessed by the software, those files can then be imported into the SDMS. Y 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. Response: Alfresco Community doesn't seem to offer data capture capabilities. However, through the Records Management module, users can manually set up retention periods on imported files via holds with user permissions and apply records or folders to the hold. N 1.3.316 The system can remove data from client machines upon upload and/or backup, based on a schedule or retention policy. Response: This functionality does not appear to be included in the SDMS. U 1.3.317 The system allows users to review, restore, and reprocess original native instrument data on the original instrument acquisition software. Response: The system can not directly interface with instruments. However, users may be able to download a native instrument data file from Alfresco to their machine and then upload that file to the original instrument again via webLiMS' LabVia. This should be confirmed. N 1.3.318 The system allows users to open and view captured native instrument files without restoring them. Response: Unless the native instrument file in the Alfresco Community repository has a supported file type, it will not be able to be opened or viewed in the Alfresco UI. You can always attempt to download it from the repository to your machine and open/view it from there. N 1.3.319 The system allows captured processed data to be reused by other applications without having to reprocess it. Response: Alfresco Community doesn't seem to offer data capture and processing capabilities. N 1.3.320 The system provides a method to extract data points from captured processed data and present it in a human-readable format. Response: Alfresco Community doesn't seem to offer data capture and processing capabilities. N 1.3.321 The system can parse captured data files containing specified metadata into a live results table. Response: Alfresco Community doesn't seem to offer data capture and processing capabilities. However, files with metadata-friendly MIME types imported into the system can be searched, filtered, and presented in a table based on metadata data. 1.3.4 Data archiving and migration 1.3.4 Data archiving and migration Requirement code Requirement # and requirement N 1.3.400 The system provides data archiving functionality for all contained data, without requiring an off-line mode. Response: The system does not have the inherent ability to put stored files into an archived folder and make those files uneditable. This requires custom coding. N 1.3.401 The system allows for a configurable scheduled archive, not requiring human interaction with the data to be archived. Response: The system does not have the inherent ability to put stored files into an archived folder and make those files uneditable. This requires custom coding. N 1.3.402 The system allows for a scheduled archive of data directly captured from a specific native instrument. Response: The system does not have the inherent ability to put stored files into an archived folder and make those files uneditable. This requires custom coding. N 1.3.403 The system permits native instrument data to be archived and restored with its original directory structure. Response: The system does not have the inherent ability to put stored files into an archived folder and make those files uneditable. This requires custom coding. N 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. Response: The system does not have the inherent ability to put stored files into an archived folder and make those files uneditable. This requires custom coding. N 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. Response: The system does not have the inherent ability to put stored files into an archived folder and make those files uneditable. This requires custom coding. N 1.3.406 The system can perform archive and restore functions simultaneously with data capture and viewing functions, without disruption. Response: The system does not have the inherent ability to put stored files into an archived folder and make those files uneditable. This requires custom coding. N 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. Response: According to Alfresco documentation "[y]ou can only perform an import/export between compatible versions of Alfresco, which generally means the same version." Migration of data exported from an older version does not seem possible. 1.3.5 Instruments 1.3.5 Instruments Requirement code Requirement # and requirement N 1.3.500 The system bilaterally interfaces with instruments and related software based on the Unix and Windows platforms. Response: Alfresco Community is not able to directly interface with instruments. However, via the webLiMS LabVia application, indirect interfacing of instruments with the webLiMS-hosted Alfresco is possible. N 1.3.501 The system can download data directly from laboratory instruments. Response: Alfresco Community is not able to directly interface with instruments. However, via the webLiMS LabVia application, downloading of instrument data (and the transition of that data to Alfresco) is possible. U 1.3.502 The system can track and report on the usage of attached laboratory instruments. Response: Alfresco Community is not able to directly interface with instruments. However, instruments can be managed via the webLiMS LabVia application, though it's not clear if it can track and report on usage. U 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. Response: Alfresco Community is not able to directly interface with instruments. However, instruments can be managed via the webLiMS LabVia application, though it's not clear if they can be automatically removed from operation. U 1.3.504 The system maintains a reportable database of preventative maintenance, calibration, and repair records for attached laboratory instruments. Response: Alfresco Community is not able to directly interface with instruments. However, instruments can be managed via the webLiMS LabVia application, though it's not clear if it keeps maintenance, etc. records. U 1.3.505 The system can schedule calibration, verification, and maintenance tasks on attached instruments and make that schedule available for viewing. Response: Alfresco Community is not able to directly interface with instruments. However, instruments can be managed via the webLiMS LabVia application, though it's not clear if it can schedule tasks on attached instruments. U 1.3.506 The system allows users to create and edit instrument maintenance profiles. Response: Alfresco Community is not able to directly interface with instruments. However, instruments can be managed via the webLiMS LabVia application, though it's not clear if it supports instrument maintenance profiles. 1.3.6 External system interfaces 1.3.6 External system interfaces Requirement code Requirement # and requirement Y 1.3.600. The system supports a library of common electronic data deliverable (EDD) formats. Response: Technically Alfresco Community remains "format-agnostic," meaning any file type can be uploaded to the system. Data in the EDD specification won't be able to be viewed in the Alfresco UI, however. N 1.3.601 The system can transfer data to and from other record management systems. Response: Alfresco Community doesn't inherently seem able to import and export data to other systems unless the other systems are also repositories run on the same version of Alfresco Community. It is still possible to download files from Alfresco to your system and then transfer them to another record management system. Y 1.3.602 The system integrates with Microsoft Exchange services. Response: The Alfresco documentation states: SharePoint Protocol has been implemented by Alfresco starting with Labs 3a release. It allows Microsoft Office Suite Applications (Word, PowerPoint, Excel) to interact with Alfresco as if it was SharePoint. Y 1.3.603 The system can import data from and export data to Microsoft Word, Excel, Access, and/or Powerpoint. Response: Files can be loaded, edited, saved, and exported from within Alfresco using the SharePoint Protocol. Y 1.3.604 The system can interface with non-Microsoft programs. Response: With the addition of community add-ons, integration with programs like Lotus Notes, LibreOffice, and JIRA is possible. Google Docs integration is also possible. N 1.3.605 The system can interface with enterprise resource planning (ERP) systems. Response: Alfresco Community does not inherently connect with ERP systems; a connector or add-on must be developed. Others have attempted this with systems like ADempiere and SAP ERP. Note that the webLiMS suite, however, includes an ERP that can potentially integrate with the SDMS. N 1.3.606 The system can interface with internal and external laboratory systems like laboratory information management systems (LIMS) and electronic laboratory notebooks (ELNs). Response: Alfresco Community does not inherently connect with ERP systems. However, the webLiMS suite includes a LIMS/LIS/ELN that can potentially integrate with the SDMS. U 1.3.607 The system can leverage the application programming interface (API) of other systems to establish integration between systems. Response: This functionality is not clear. N 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. Response: The system does not inherently have this functionality. U 1.3.609 The system supports dockable mobile devices and handles information exchange between them and the system. Response: Alfresco Community can normally be accessed via the Alfresco Mobile application for Android and iPhone. It's not clear if webLiMS users will be able to access their cloud-hosted SDMS using the mobile app, however. Y 1.3.610 The system supports the use of optical character recognition (OCR) software. Response: OCR support can be added via community add-ons. 1.3.7 Reporting 1.3.7 Reporting Requirement code Requirement # and requirement 1.3.700 The system includes a versatile report writer and forms generator that can generate reports from any data in the system. Response: 1.3.701 The system can interface with a third-party reporting application. Response: 1.3.702 The system allows the development of custom templates for different types of reports. Response: 1.3.703 The system maintains template versions and renditions, allowing management and tracking of the template over time. Response: 1.3.704 The system uses Microsoft Office tools for formatting reports. Response: 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. Response: 1.3.706 The system makes graphic and tabular data vector-scalable in reports. Response: 1.3.707 The system allows for internal hyperlinking to source data in reports. Response: 1.3.708 The system allows users to manually adjust inaccurate data parsing routines for reports. Response: 1.3.709 The system can indicate whether a report is preliminary, amended, corrected, or final while retaining revision history. Response: 1.3.710 The system can automatically generate laboratory reports of findings and other written documents. Response: 1.3.711 The system provides an ad-hoc web reporting interface to report on user-selected criteria. Response: 1.3.712 The system can automatically generate and post periodic static summary reports on an internal web server. Response: 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. Response: 1.3.714 The system supports PDF/A, an ISO-standardized version of the Portable Document Format (PDF). Response: 1.3.715 The system includes a rules engine to determine the recipients of reports and other documents based on definable parameters. Response: 1.3.716 The system provides printer-friendly audit trails for cleaner reporting of audit data. Response: 1.3.717 The system provides an interface for external clients to search, generate, and view processed data reports based on metadata tags. Response: 1.3.718 The system provides document workflow management tools for streamlining their creation, review, modification, and approval. Response: