User:Shawndouglas/sandbox/sublevel3

This is sublevel3 of my sandbox, where I play with features and test MediaWiki code. If you wish to leave a comment for me, please see my discussion page instead.

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

1.0 Demonstration

1.0 Demonstration
Requirement code	Requirement # and requirement
	1.0.000 The system can be tried via an online and/or on-site demonstration.
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1.1 Information technology

1.1.1 General IT

1.1.1 General IT
Requirement code	Requirement # and requirement
	1.1.100 The system operates with a traditional client-server architecture, with software installed on each machine that needs to access the system.
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	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.
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	1.1.102 The system contains a single, centralized database that supports multiple sites and departments.
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	1.1.103 The system's database conforms to the Open Database Connectivity Standard (ODBC).
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	1.1.104 The system is designed so upgrades to the back-end database do not require extensive reconfiguration or effectively cripple the system.
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	1.1.105 The system is designed to not be impacted by multiple users or failover processes.
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	1.1.106 The system applies security features to all system files.
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	1.1.107 The system applies log-in security to all servers and workstations accessing it.
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	1.1.108 The system provides a workstation and server authentication mechanism.
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	1.1.109 The system applies Secured Socket Layer (SSL) encryption on the web client interface.
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	1.1.110 The system encrypts client passwords in a database, with support for multi-case and special characters.
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	1.1.111 The system uses TCP/IP as its network transport.
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	1.1.112 The system allows automated backup and restore capability without support intervention, as well as manual backups.
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	1.1.113 The system maintains the transactional history of system administrators.
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1.1.2 Hardware environment

1.1.2 Hardware environment
Requirement code	Requirement # and requirement
	1.1.200 The system proves compatible with a variety of hardware environments.
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	1.1.201 The system can be utilized with a touch-screen.\|
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1.1.3 Software environment

1.1.3 Software environment
Requirement code	Requirement # and requirement
	1.1.300 The system proves compatible with a variety of software environments.
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	1.1.301 The system utilizes a non-proprietary database such as Oracle or Microsoft SQL Server.
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1.2 Regulatory compliance and security

1.2.1 Regulatory compliance

1.2.1 Regulatory compliance
Requirement code	Requirement # and requirement
	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.
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	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.
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	1.2.102 The system supports USP <232>/<233> requirements.
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	1.2.103 The system supports GALP and/or GAMP standards.
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	1.2.104 The system supports the U.S. DoD 5015.2 Standard.
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	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.
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	1.2.106 The system audit log retains all data, prohibits any deletions, and allows user comments.
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	1.2.107 The system maintains audit trails at least as long as the records to which they pertain.
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	1.2.108 The system provides additional persistent auditing capabilities, such as the audit of cancelled uploads and scheduled system functions.
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	1.2.109 The system provides the ability to both automatically and manually add secure electronic signatures to documents and other data.
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	1.2.110 The system can automatically validate and approve data prior to being moved to the main database.
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1.2.2 Security

1.2.2 Security
Requirement code	Requirement # and requirement
	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.
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	1.2.201 The system allows administrators and users to reset user passwords.
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	1.2.202 The system features and enforces adjustable rules concerning password complexity, reuse, and expiration.
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	1.2.203 The system can lock a user out after a specified number of consecutive failed log-in attempts.
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	1.2.204 The system provides the option for automatic user logout based on keyboard or mouse inactivity.
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	1.2.205 The system makes authority checks to ensure only authorized individuals can use the system to perform an operation.
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	1.2.206 The system allows authorized users to modify records, while also maintaining an audit trail of such actions.
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	1.2.207 The system allows authorized users to manually delete records, while also maintaining an audit trail of such actions.
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	1.2.208 The system prompts users to declare a reason for making changes to or deleting data in the system.
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	1.2.209 The system allows authorized users to generate a detailed user access record.
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	1.2.210 The system provides email notification of lockout, security access, and improper workstation access.
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	1.2.211 The system provides a mechanism to allow a user read-only access to stored data.
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	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.
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	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.
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	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.
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	1.2.215 The system employs automatic file encryption on stored data.
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	1.2.216 The system employs checks to enforce permitted sequencing of steps and events.
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1.3 General system functions

1.3.1 General functions

1.3.1 General functions
Requirement code	Requirement # and requirement
	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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	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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	1.3.102 The system permits remote access for users, system admins, and support agents.
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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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	1.3.104 The system allows tabular data to be sorted and filtered.
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	1.3.105 The system can send on-screen output to a printer or file without contradicting view-only statuses.
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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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	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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	1.3.108 The system can generate metadata tags via derived value rules.
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	1.3.109 The system allows users to manually add metadata tags to files.
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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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	1.3.111 The system allows users to search for similar records based upon a set of metadata tag values.
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	1.3.112 The system allows users to build, save, and edit queries for future use.
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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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	1.3.114 The system allows users to attach comments to data and files.
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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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	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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	1.3.117 The system notifies users of events like the scheduling and completion of tasks.
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	1.3.118 The system includes the ability to set up alerts via email.
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	1.3.119 The system offers integrated or online user help screens.
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	1.3.120 The system includes data analysis and calculation tools.
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1.3.2 Configuration and customization

1.3.2 Configuration and customization
Requirement code	Requirement # and requirement
	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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	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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	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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	1.3.203 The system allows for the integration of additional printers and scanners both locally and externally.
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1.3.3 Data capture

1.3.3 Data capture
Requirement code	Requirement # and requirement
	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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	1.3.301 The system can manage and store media objects like digital photos, bitmaps, movies, and audio files.
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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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	1.3.303 The system can interface with and import existing data from other databases and file shares.
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	1.3.304 The system supports data capture from a Citrix-based environment.
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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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	1.3.306 The system allows users to organize captured data by project, date, location, instrument, etc.
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	1.3.307 The system can route captured data based upon specified metadata tags.
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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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	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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	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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	1.3.311 The system can automatically normalize and store incoming data to a technology-neutral format like XML.
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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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	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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	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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	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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	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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	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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	1.3.318 The system allows users to open and view captured native instrument files without restoring them.
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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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	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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	1.3.321 The system can parse captured data files containing specified metadata into a live results table.
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1.3.4 Data archiving and migration

1.3.4 Data archiving and migration
Requirement code	Requirement # and requirement
	1.3.400 The system provides data archiving functionality for all contained data, without requiring an off-line mode.
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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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	1.3.402 The system allows for a scheduled archive of data directly captured from a specific native instrument.
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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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	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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	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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	1.3.406 The system can perform archive and restore functions simultaneously with data capture and viewing functions, without disruption.
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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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1.3.5 Instruments

1.3.5 Instruments
Requirement code	Requirement # and requirement
	1.3.500 The system bilaterally interfaces with instruments and related software based on the Unix and Windows platforms.
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	1.3.501 The system can download data directly from laboratory instruments.
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	1.3.502 The system can track and report on the usage of attached laboratory instruments.
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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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	1.3.504 The system maintains a reportable database of preventative maintenance, calibration, and repair records for attached laboratory instruments.
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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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	1.3.506 The system allows users to create and edit instrument maintenance profiles.
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1.3.6 External system interfaces

1.3.6 External system interfaces
Requirement code	Requirement # and requirement
	1.3.600. The system supports a library of common electronic data deliverable (EDD) formats.
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	1.3.601 The system can transfer data to and from other record management systems.
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	1.3.602 The system integrates with Microsoft Exchange services.
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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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	1.3.604 The system can interface with non-Microsoft programs.
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	1.3.605 The system can interface with enterprise resource planning (ERP) systems.
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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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	1.3.607 The system can leverage the application programming interface (API) of other systems to establish integration between systems.
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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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	1.3.609 The system supports dockable mobile devices and handles information exchange between them and the system.
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	1.3.610 The system supports the use of optical character recognition (OCR) software.
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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.
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	1.3.701 The system can interface with a third-party reporting application.
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	1.3.702 The system allows the development of custom templates for different types of reports.
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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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	1.3.704 The system uses Microsoft Office tools for formatting reports.
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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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	1.3.706 The system makes graphic and tabular data vector-scalable in reports.
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	1.3.707 The system allows for internal hyperlinking to source data in reports.
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	1.3.708 The system allows users to manually adjust inaccurate data parsing routines for reports.
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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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	1.3.710 The system can automatically generate laboratory reports of findings and other written documents.
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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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	1.3.712 The system can automatically generate and post periodic static summary reports on an internal web server.
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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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	1.3.714 The system supports PDF/A, an ISO-standardized version of the Portable Document Format (PDF).
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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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	1.3.716 The system provides printer-friendly audit trails for cleaner reporting of audit data.
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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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	1.3.718 The system provides document workflow management tools for streamlining their creation, review, modification, and approval.
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