Difference between revisions of "User:Shawndouglas/sandbox/sublevel3"

Revision as of 18:54, 22 October 2014

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
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
	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:
	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:
	1.1.102 The system contains a single, centralized database that supports multiple sites and departments.
Response:
	1.1.103 The system's database conforms to the Open Database Connectivity Standard (ODBC).
Response:
	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:
	1.1.105 The system is designed to not be impacted by multiple users or failover processes.
Response:
	1.1.106 The system applies security features to all system files.
Response:
	1.1.107 The system applies log-in security to all servers and workstations accessing it.
Response:
	1.1.108 The system provides a workstation and server authentication mechanism.
Response:
	1.1.109 The system applies Secured Socket Layer (SSL) encryption on the web client interface.
Response:
	1.1.110 The system encrypts client passwords in a database, with support for multi-case and special characters.
Response:
	1.1.111 The system uses TCP/IP as its network transport.
Response:
	1.1.112 The system allows automated backup and restore capability without support intervention, as well as manual backups.
Response:
	1.1.113 The system maintains the transactional history of system administrators.
Response:

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.
Response:
	1.1.201 The system can be utilized with a touch-screen.\|
Response:

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.
Response:
	1.1.301 The system utilizes a non-proprietary database such as Oracle or Microsoft SQL Server.
Response:

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

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

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.
Response:
	1.3.101 The system allows authorized users to configure their GUI to a specific language, character set, and time zone.
Response:
	1.3.102 The system permits remote access for users, system admins, and support agents.
Response:
	1.3.103 The system allows for the use of navigation keys to freely move from field to field.
Response:
	1.3.104 The system allows tabular data to be sorted and filtered.
Response:
	1.3.105 The system can send on-screen output to a printer or file without contradicting view-only statuses.
Response:
	1.3.106 The system contains one or more spell-check dictionaries that allow authorized users to add, edit, or remove entries.
Response:
	1.3.107 The system uses human-readable metadata tags to better describe, index, and store all captured and archived data.
Response:
	1.3.108 The system can generate metadata tags via derived value rules.
Response:
	1.3.109 The system allows users to manually add metadata tags to files.
Response:
	1.3.110 The system provides full metadata, keyword, and field search capability, including the use of multiple search criteria.
Response:
	1.3.111 The system allows users to search for similar records based upon a set of metadata tag values.
Response:
	1.3.112 The system allows users to build, save, and edit queries for future use.
Response:
	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:
	1.3.114 The system allows users to attach comments to data and files.
Response:
	1.3.115 The system's file viewer/explorer allow users to view native, processed, and archived data in its native file structure.
Response:
	1.3.116 The system can link objects to other objects, e.g. linking a standard operating procedure (SOP) to a test result.
Response:
	1.3.117 The system notifies users of events like the scheduling and completion of tasks.
Response:
	1.3.118 The system includes the ability to set up alerts via email.
Response:
	1.3.119 The system offers integrated or online user help screens.
Response:
	1.3.120 The system includes data analysis and calculation tools.
Response:

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.
Response:
	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:
	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:
	1.3.203 The system allows for the integration of additional printers and scanners both locally and externally.
Response:

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.
Response:
	1.3.301 The system can manage and store media objects like digital photos, bitmaps, movies, and audio files.
Response:
	1.3.302 The system allows multiple native instruments and users to enter data into the system simultaneously without disruption.
Response:
	1.3.303 The system can interface with and import existing data from other databases and file shares.
Response:
	1.3.304 The system supports data capture from a Citrix-based environment.
Response:
	1.3.305 The system allows file indexes to be stored centrally while associated files are stored geographically.
Response:
	1.3.306 The system allows users to organize captured data by project, date, location, instrument, etc.
Response:
	1.3.307 The system can route captured data based upon specified metadata tags.
Response:
	1.3.308 The system allows full on-screen review and approval of native instrument data prior to database commitment.
Response:
	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:
	1.3.310 The system has a tool that allows users to capture data printed to it as a searchable PDF file.
Response:
	1.3.311 The system can automatically normalize and store incoming data to a technology-neutral format like XML.
Response:
	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:
	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:
	1.3.314 The system allows users to manually upload instrument data files that are not part of a scheduled upload.
Response:
	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:
	1.3.316 The system can remove data from client machines upon upload and/or backup, based on a schedule or retention policy.
Response:
	1.3.317 The system allows users to review, restore, and reprocess original native instrument data on the original instrument acquisition software.
Response:
	1.3.318 The system allows users to open and view captured native instrument files without restoring them.
Response:
	1.3.319 The system allows captured processed data to be reused by other applications without having to reprocess it.
Response:
	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:
	1.3.321 The system can parse captured data files containing specified metadata into a live results table.
Response:

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.
Response:
	1.3.401 The system allows for a configurable scheduled archive, not requiring human interaction with the data to be archived.
Response:
	1.3.402 The system allows for a scheduled archive of data directly captured from a specific native instrument.
Response:
	1.3.403 The system permits native instrument data to be archived and restored with its original directory structure.
Response:
	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:
	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:
	1.3.406 The system can perform archive and restore functions simultaneously with data capture and viewing functions, without disruption.
Response:
	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:

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.
Response:
	1.3.501 The system can download data directly from laboratory instruments.
Response:
	1.3.502 The system can track and report on the usage of attached laboratory instruments.
Response:
	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:
	1.3.504 The system maintains a reportable database of preventative maintenance, calibration, and repair records for attached laboratory instruments.
Response:
	1.3.505 The system can schedule calibration, verification, and maintenance tasks on attached instruments and make that schedule available for viewing.
Response:
	1.3.506 The system allows users to create and edit instrument maintenance profiles.
Response:

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.
Response:
	1.3.601 The system can transfer data to and from other record management systems.
Response:
	1.3.602 The system integrates with Microsoft Exchange services.
Response:
	1.3.603 The system can import data from and export data to Microsoft Word, Excel, Access, and/or Powerpoint.
Response:
	1.3.604 The system can interface with non-Microsoft programs.
Response:
	1.3.605 The system can interface with enterprise resource planning (ERP) systems.
Response:
	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:
	1.3.607 The system can leverage the application programming interface (API) of other systems to establish integration between systems.
Response:
	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:
	1.3.609 The system supports dockable mobile devices and handles information exchange between them and the system.
Response:
	1.3.610 The system supports the use of optical character recognition (OCR) software.
Response:

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:

Difference between revisions of "User:Shawndouglas/sandbox/sublevel3"

Revision as of 18:54, 22 October 2014

Contents

Sandbox begins below

1.0 Demonstration

1.1 Information technology

1.1.1 General IT

1.1.2 Hardware environment

1.1.3 Software environment

1.2 Regulatory compliance and security

1.2.1 Regulatory compliance

1.2.2 Security

1.3 General system functions

1.3.1 General functions

1.3.2 Configuration and customization

1.3.3 Data capture

1.3.4 Data archiving and migration

1.3.5 Instruments

1.3.6 External system interfaces

1.3.7 Reporting

Navigation menu

Page actions

Page actions

Personal tools

Navigation

Search

Tools

Popular publications

Print/export

@@ Line 25: / Line 25: @@
    ! style="color:brown; background-color:#ffffee; width:1200px;"| Requirement # and requirement
   |-
-   | style="padding:5px; text-align:center;" | '''N'''
+   ! style="padding:5px;" | N
    | style="padding:5px; width:1200px;" |'''1.0.000''' The system can be tried via an online and/or on-site demonstration.
   |-
@@ Line 45: / Line 45: @@
    ! style="color:brown; background-color:#ffffee; width:1200px;"| Requirement # and requirement
   |-
-   | style="padding:5px;" |
+   ! style="padding:5px;" |
    | style="padding:5px; width:1200px;" |'''1.1.100''' The system operates with a traditional client-server architecture, with software installed on each machine that needs to access the system.
   |-
@@ Line 51: / Line 51: @@
    | style="background-color:white; padding:5px;" |
   |-
-   | style="padding:5px;" |
+   ! style="padding:5px;" |
    | style="padding:5px; width:1200px;" |'''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.
   |-
@@ Line 57: / Line 57: @@
    | style="background-color:white; padding:5px;" |
   |-
-   | style="padding:5px;" |
+   ! style="padding:5px;" |
    | style="padding:5px; width:1200px;" |'''1.1.102''' The system contains a single, centralized database that supports multiple sites and departments.
   |-
@@ Line 63: / Line 63: @@
    | style="background-color:white; padding:5px;" |
   |-
-   | style="padding:5px;" |
+   ! style="padding:5px;" |
    | style="padding:5px; width:1200px;" |'''1.1.103''' The system's database conforms to the [[ODBC|Open Database Connectivity Standard]] (ODBC).
   |-
@@ Line 69: / Line 69: @@
    | style="background-color:white; padding:5px;" |
   |-
-   | style="padding:5px;" |
+   ! style="padding:5px;" |
    | style="padding:5px; width:1200px;" |'''1.1.104''' The system is designed so upgrades to the back-end database do not require extensive reconfiguration or effectively cripple the system.
   |-
@@ Line 75: / Line 75: @@
    | style="background-color:white; padding:5px;" |
   |-
-   | style="padding:5px;" |
+   ! style="padding:5px;" |
    | style="padding:5px; width:1200px;" |'''1.1.105''' The system is designed to not be impacted by multiple users or failover processes.
   |-
@@ Line 81: / Line 81: @@
    | style="background-color:white; padding:5px;" |
   |-
-   | style="padding:5px;" |
+   ! style="padding:5px;" |
    | style="padding:5px; width:1200px;" |'''1.1.106''' The system applies security features to all system files.
   |-
@@ Line 87: / Line 87: @@
    | style="background-color:white; padding:5px;" |
   |-
-   | style="padding:5px;" |
+   ! style="padding:5px;" |
    | style="padding:5px; width:1200px;" |'''1.1.107''' The system applies log-in security to all servers and workstations accessing it.
   |-
@@ Line 93: / Line 93: @@
    | style="background-color:white; padding:5px;" |
   |-
-   | style="padding:5px;" |
+   ! style="padding:5px;" |
    | style="padding:5px; width:1200px;" |'''1.1.108''' The system provides a workstation and server authentication mechanism.
   |-
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    | style="background-color:white; padding:5px;" |
   |-
-   | style="padding:5px;" |
+   ! style="padding:5px;" |
    | style="padding:5px; width:1200px;" |'''1.1.109''' The system applies Secured Socket Layer (SSL) encryption on the web client interface.
   |-
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    | style="background-color:white; padding:5px;" |
   |-
-   | style="padding:5px;" |
+   ! style="padding:5px;" |
    | style="padding:5px; width:1200px;" |'''1.1.110''' The system encrypts client passwords in a database, with support for multi-case and special characters.
   |-
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    | style="background-color:white; padding:5px;" |
   |-
-   | style="padding:5px;" |
+   ! style="padding:5px;" |
    | style="padding:5px; width:1200px;" |'''1.1.111''' The system uses TCP/IP as its network transport.
   |-
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    | style="background-color:white; padding:5px;" |
   |-
-   | style="padding:5px;" |
+   ! style="padding:5px;" |
    | style="padding:5px; width:1200px;" |'''1.1.112''' The system allows automated backup and restore capability without support intervention, as well as manual backups.
   |-
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    | style="background-color:white; padding:5px;" |
   |-
-   | style="padding:5px;" |
+   ! style="padding:5px;" |
    | style="padding:5px; width:1200px;" |'''1.1.113''' The system maintains the transactional history of system administrators.
   |-
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    ! style="color:brown; background-color:#ffffee; width:1200px;"| Requirement # and requirement
   |-
-   | style="padding:5px;" |
+   ! style="padding:5px;" |
    | style="padding:5px; width:1200px;" |'''1.1.200''' The system proves compatible with a variety of hardware environments.
   |-
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    | style="background-color:white; padding:5px;" |
   |-
-   | style="padding:5px;" |
+   ! style="padding:5px;" |
    | style="padding:5px; width:1200px;" |'''1.1.201''' The system can be utilized with a touch-screen.|
   |-
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    ! style="color:brown; background-color:#ffffee; width:1200px;"| Requirement # and requirement
   |-
-   | style="padding:5px;" |
+   ! style="padding:5px;" |
    | style="padding:5px; width:1200px;" |'''1.1.300''' The system proves compatible with a variety of software environments.
   |-
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    | style="background-color:white; padding:5px;" |
   |-
-   | style="padding:5px;" |
+   ! style="padding:5px;" |
    | style="padding:5px; width:1200px;" |'''1.1.301''' The system utilizes a non-proprietary database such as Oracle or Microsoft SQL Server.
   |-
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    ! style="color:brown; background-color:#ffffee; width:1200px;"| Requirement # and requirement
   |-
-   | style="padding:5px;" |
+   ! style="padding:5px;" |
    | style="padding:5px; width:1200px;" |'''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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    | style="background-color:white; padding:5px;" |
   |-
-   | style="padding:5px;" |
+   ! style="padding:5px;" |
    | style="padding:5px; width:1200px;" |'''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.
   |-
@@ Line 199: / Line 199: @@
    | style="background-color:white; padding:5px;" |
   |-
-   | style="padding:5px;" |
+   ! style="padding:5px;" |
    | style="padding:5px; width:1200px;" |'''1.2.102''' The system supports USP <232>/<233> requirements.
   |-
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    | style="background-color:white; padding:5px;" |
   |-
-   | style="padding:5px;" |
+   ! style="padding:5px;" |
    | style="padding:5px; width:1200px;" |'''1.2.103''' The system supports [[GALP]] and/or [[GAMP]] standards.
   |-
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    | style="background-color:white; padding:5px;" |
   |-
-   | style="padding:5px;" |
+   ! style="padding:5px;" |
    | style="padding:5px; width:1200px;" |'''1.2.104''' The system supports the U.S. DoD 5015.2 Standard.
   |-
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    | style="background-color:white; padding:5px;" |
   |-
-   | style="padding:5px;" |
+   ! style="padding:5px;" |
    | style="padding:5px; width:1200px;" |'''1.2.105''' The system maintains date- and time-stamped [[audit trail|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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    | style="background-color:white; padding:5px;" |
   |-
-   | style="padding:5px;" |
+   ! style="padding:5px;" |
    | style="padding:5px; width:1200px;" |'''1.2.106''' The system audit log retains all data, prohibits any deletions, and allows user comments.
   |-
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    | style="background-color:white; padding:5px;" |
   |-
-   | style="padding:5px;" |
+   ! style="padding:5px;" |
    | style="padding:5px; width:1200px;" |'''1.2.107''' The system maintains audit trails at least as long as the records to which they pertain.
   |-
@@ Line 235: / Line 235: @@
    | style="background-color:white; padding:5px;" |
   |-
-   | style="padding:5px;" |
+   ! style="padding:5px;" |
    | style="padding:5px; width:1200px;" |'''1.2.108''' The system provides additional persistent auditing capabilities, such as the audit of cancelled uploads and scheduled system functions.
   |-
@@ Line 241: / Line 241: @@
    | style="background-color:white; padding:5px;" |
   |-
-   | style="padding:5px;" |
+   ! style="padding:5px;" |
    | style="padding:5px; width:1200px;" |'''1.2.109''' The system provides the ability to both automatically and manually add secure [[ELN feature#Electronic signatures|electronic signatures]] to documents and other data.
   |-
@@ Line 247: / Line 247: @@
    | style="background-color:white; padding:5px;" |
   |-
-   | style="padding:5px;" |
+   ! style="padding:5px;" |
    | style="padding:5px; width:1200px;" |'''1.2.110''' The system can automatically validate and approve data prior to being moved to the main database.
   |-
@@ Line 263: / Line 263: @@
    ! style="color:brown; background-color:#ffffee; width:1200px;"| Requirement # and requirement
   |-
-   | style="padding:5px;" |
+   ! style="padding:5px;" |
    | style="padding:5px; width:1200px;" |'''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, [[LIMS feature#Configurable roles and security|role]], and/or specific function.
   |-
@@ Line 269: / Line 269: @@
    | style="background-color:white; padding:5px;" |
   |-
-   | style="padding:5px;" |
+   ! style="padding:5px;" |
    | style="padding:5px; width:1200px;" |'''1.2.201''' The system allows administrators and users to reset user passwords.
   |-
@@ Line 275: / Line 275: @@
    | style="background-color:white; padding:5px;" |
   |-
-   | style="padding:5px;" |
+   ! style="padding:5px;" |
    | style="padding:5px; width:1200px;" |'''1.2.202''' The system features and enforces adjustable rules concerning password complexity, reuse, and expiration.
   |-
@@ Line 281: / Line 281: @@
    | style="background-color:white; padding:5px;" |
   |-
-   | style="padding:5px;" |
+   ! style="padding:5px;" |
    | style="padding:5px; width:1200px;" |'''1.2.203''' The system can lock a user out after a specified number of consecutive failed log-in attempts.
   |-
@@ Line 287: / Line 287: @@
    | style="background-color:white; padding:5px;" |
   |-
-   | style="padding:5px;" |
+   ! style="padding:5px;" |
    | style="padding:5px; width:1200px;" |'''1.2.204''' The system provides the option for automatic user logout based on keyboard or mouse inactivity.
   |-
@@ Line 293: / Line 293: @@
    | style="background-color:white; padding:5px;" |
   |-
-   | style="padding:5px;" |
+   ! style="padding:5px;" |
    | style="padding:5px; width:1200px;" |'''1.2.205''' The system makes authority checks to ensure only authorized individuals can use the system to perform an operation.
   |-
@@ Line 299: / Line 299: @@
    | style="background-color:white; padding:5px;" |
   |-
-   | style="padding:5px;" |
+   ! style="padding:5px;" |
    | style="padding:5px; width:1200px;" |'''1.2.206''' The system allows authorized users to modify records, while also maintaining an audit trail of such actions.
   |-
@@ Line 305: / Line 305: @@
    | style="background-color:white; padding:5px;" |
   |-
-   | style="padding:5px;" |
+   ! style="padding:5px;" |
    | style="padding:5px; width:1200px;" |'''1.2.207''' The system allows authorized users to manually delete records, while also maintaining an audit trail of such actions.
   |-
@@ Line 311: / Line 311: @@
    | style="background-color:white; padding:5px;" |
   |-
-   | style="padding:5px;" |
+   ! style="padding:5px;" |
    | style="padding:5px; width:1200px;" |'''1.2.208''' The system prompts users to declare a reason for making changes to or deleting data in the system.
   |-
@@ Line 317: / Line 317: @@
    | style="background-color:white; padding:5px;" |
   |-
-   | style="padding:5px;" |
+   ! style="padding:5px;" |
    | style="padding:5px; width:1200px;" |'''1.2.209''' The system allows authorized users to generate a detailed user access record.
   |-
@@ Line 323: / Line 323: @@
    | style="background-color:white; padding:5px;" |
   |-
-   | style="padding:5px;" |
+   ! style="padding:5px;" |
    | style="padding:5px; width:1200px;" |'''1.2.210''' The system provides email notification of lockout, security access, and improper workstation access.
   |-
@@ Line 329: / Line 329: @@
    | style="background-color:white; padding:5px;" |
   |-
-   | style="padding:5px;" |
+   ! style="padding:5px;" |
    | style="padding:5px; width:1200px;" |'''1.2.211''' The system provides a mechanism to allow a user read-only access to stored data.
   |-
@@ Line 335: / Line 335: @@
    | style="background-color:white; padding:5px;" |
   |-
-   | style="padding:5px;" |
+   ! style="padding:5px;" |
    | style="padding:5px; width:1200px;" |'''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.
   |-
@@ Line 341: / Line 341: @@
    | style="background-color:white; padding:5px;" |
   |-
-   | style="padding:5px;" |
+   ! style="padding:5px;" |
    | style="padding:5px; width:1200px;" |'''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.
   |-
@@ Line 347: / Line 347: @@
    | style="background-color:white; padding:5px;" |
   |-
-   | style="padding:5px;" |
+   ! style="padding:5px;" |
    | style="padding:5px; width:1200px;" |'''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.
   |-
@@ Line 353: / Line 353: @@
    | style="background-color:white; padding:5px;" |
   |-
-   | style="padding:5px;" |
+   ! style="padding:5px;" |
    | style="padding:5px; width:1200px;" |'''1.2.215''' The system employs automatic file encryption on stored data.
   |-
@@ Line 359: / Line 359: @@
    | style="background-color:white; padding:5px;" |
   |-
-   | style="padding:5px;" |
+   ! style="padding:5px;" |
    | style="padding:5px; width:1200px;" |'''1.2.216''' The system employs checks to enforce permitted sequencing of steps and events.
   |-
@@ Line 379: / Line 379: @@
    ! style="color:brown; background-color:#ffffee; width:1200px;"| Requirement # and requirement
   |-
-   | style="padding:5px;" |
+   ! style="padding:5px;" |
    | style="padding:5px; width:1200px;" |'''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.
   |-
@@ Line 385: / Line 385: @@
    | style="background-color:white; padding:5px;" |
   |-
-   | style="padding:5px;" |
+   ! style="padding:5px;" |
    | style="padding:5px; width:1200px;" |'''1.3.101''' The system allows authorized users to configure their GUI to a specific language, character set, and time zone.
   |-
@@ Line 391: / Line 391: @@
    | style="background-color:white; padding:5px;" |
   |-
-   | style="padding:5px;" |
+   ! style="padding:5px;" |
    | style="padding:5px; width:1200px;" |'''1.3.102''' The system permits remote access for users, system admins, and support agents.
   |-
@@ Line 397: / Line 397: @@
    | style="background-color:white; padding:5px;" |
   |-
-   | style="padding:5px;" |
+   ! style="padding:5px;" |
    | style="padding:5px; width:1200px;" |'''1.3.103''' The system allows for the use of navigation keys to freely move from field to field.
   |-
@@ Line 403: / Line 403: @@
    | style="background-color:white; padding:5px;" |
   |-
-   | style="padding:5px;" |
+   ! style="padding:5px;" |
    | style="padding:5px; width:1200px;" |'''1.3.104''' The system allows tabular data to be sorted and filtered.
   |-
@@ Line 409: / Line 409: @@
    | style="background-color:white; padding:5px;" |
   |-
-   | style="padding:5px;" |
+   ! style="padding:5px;" |
    | style="padding:5px; width:1200px;" |'''1.3.105''' The system can send on-screen output to a printer or file without contradicting view-only statuses.
   |-
@@ Line 415: / Line 415: @@
    | style="background-color:white; padding:5px;" |
   |-
-   | style="padding:5px;" |
+   ! style="padding:5px;" |
    | style="padding:5px; width:1200px;" |'''1.3.106''' The system contains one or more spell-check dictionaries that allow authorized users to add, edit, or remove entries.
   |-
@@ Line 421: / Line 421: @@
    | style="background-color:white; padding:5px;" |
   |-
-   | style="padding:5px;" |
+   ! style="padding:5px;" |
    | style="padding:5px; width:1200px;" |'''1.3.107''' The system uses human-readable metadata tags to better describe, index, and store all captured and archived data.
   |-
@@ Line 427: / Line 427: @@
    | style="background-color:white; padding:5px;" |
   |-
-   | style="padding:5px;" |
+   ! style="padding:5px;" |
    | style="padding:5px; width:1200px;" |'''1.3.108''' The system can generate metadata tags via derived value rules.
   |-
@@ Line 433: / Line 433: @@
    | style="background-color:white; padding:5px;" |
   |-
-   | style="padding:5px;" |
+   ! style="padding:5px;" |
    | style="padding:5px; width:1200px;" |'''1.3.109''' The system allows users to manually add metadata tags to files.
   |-
@@ Line 439: / Line 439: @@
    | style="background-color:white; padding:5px;" |
   |-
-   | style="padding:5px;" |
+   ! style="padding:5px;" |
    | style="padding:5px; width:1200px;" |'''1.3.110''' The system provides full metadata, keyword, and field [[LIMS feature#Query capability|search capability]], including the use of multiple search criteria.
   |-
@@ Line 445: / Line 445: @@
    | style="background-color:white; padding:5px;" |
   |-
-   | style="padding:5px;" |
+   ! style="padding:5px;" |
    | style="padding:5px; width:1200px;" |'''1.3.111''' The system allows users to search for similar records based upon a set of metadata tag values.
   |-
@@ Line 451: / Line 451: @@
    | style="background-color:white; padding:5px;" |
   |-
-   | style="padding:5px;" |
+   ! style="padding:5px;" |
    | style="padding:5px; width:1200px;" |'''1.3.112''' The system allows users to build, save, and edit queries for future use.
   |-
@@ Line 457: / Line 457: @@
    | style="background-color:white; padding:5px;" |
   |-
-   | style="padding:5px;" |
+   ! style="padding:5px;" |
    | style="padding:5px; width:1200px;" |'''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.
   |-
@@ Line 463: / Line 463: @@
    | style="background-color:white; padding:5px;" |
   |-
-   | style="padding:5px;" |
+   ! style="padding:5px;" |
    | style="padding:5px; width:1200px;" |'''1.3.114''' The system allows users to attach comments to data and files.
   |-
@@ Line 469: / Line 469: @@
    | style="background-color:white; padding:5px;" |
   |-
-   | style="padding:5px;" |
+   ! style="padding:5px;" |
    | style="padding:5px; width:1200px;" |'''1.3.115''' The system's file viewer/explorer allow users to view native, processed, and archived data in its native file structure.
   |-
@@ Line 475: / Line 475: @@
    | style="background-color:white; padding:5px;" |
   |-
-   | style="padding:5px;" |
+   ! style="padding:5px;" |
    | style="padding:5px; width:1200px;" |'''1.3.116''' The system can link objects to other objects, e.g. linking a standard operating procedure (SOP) to a test result.
   |-
@@ Line 481: / Line 481: @@
    | style="background-color:white; padding:5px;" |
   |-
-   | style="padding:5px;" |
+   ! style="padding:5px;" |
    | style="padding:5px; width:1200px;" |'''1.3.117''' The system [[LIMS feature#Alarms and/or alerts|notifies users]] of events like the scheduling and completion of tasks.
   |-
@@ Line 487: / Line 487: @@
    | style="background-color:white; padding:5px;" |
   |-
-   | style="padding:5px;" |
+   ! style="padding:5px;" |
    | style="padding:5px; width:1200px;" |'''1.3.118''' The system includes the ability to set up alerts via email.
   |-
@@ Line 493: / Line 493: @@
    | style="background-color:white; padding:5px;" |
   |-
-   | style="padding:5px;" |
+   ! style="padding:5px;" |
    | style="padding:5px; width:1200px;" |'''1.3.119''' The system offers integrated or online user help screens.
   |-
@@ Line 499: / Line 499: @@
    | style="background-color:white; padding:5px;" |
   |-
-   | style="padding:5px;" |
+   ! style="padding:5px;" |
    | style="padding:5px; width:1200px;" |'''1.3.120''' The system includes data analysis and calculation tools.
   |-
@@ Line 515: / Line 515: @@
    ! style="color:brown; background-color:#ffffee; width:1200px;"| Requirement # and requirement
   |-
-   | style="padding:5px;" |
+   ! style="padding:5px;" |
    | style="padding:5px; width:1200px;" |'''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.
   |-
@@ Line 521: / Line 521: @@
    | style="background-color:white; padding:5px;" |
   |-
-   | style="padding:5px;" |
+   ! style="padding:5px;" |
    | style="padding:5px; width:1200px;" |'''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.
   |-
@@ Line 527: / Line 527: @@
    | style="background-color:white; padding:5px;" |
   |-
-   | style="padding:5px;" |
+   ! style="padding:5px;" |
    | style="padding:5px; width:1200px;" |'''1.3.202''' The system allows a user to [[LIMS feature#Customizable fields and/or interface|independently add fields]] without requiring reconfiguration of the system, even after routine upgrades and maintenance.
   |-
@@ Line 533: / Line 533: @@
    | style="background-color:white; padding:5px;" |
   |-
-   | style="padding:5px;" |
+   ! style="padding:5px;" |
    | style="padding:5px; width:1200px;" |'''1.3.203''' The system allows for the integration of additional printers and scanners both locally and externally.
   |-
@@ Line 549: / Line 549: @@
    ! style="color:brown; background-color:#ffffee; width:1200px;"| Requirement # and requirement
   |-
-   | style="padding:5px;" |
+   ! style="padding:5px;" |
    | style="padding:5px; width:1200px;" |'''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.
   |-
@@ Line 555: / Line 555: @@
    | style="background-color:white; padding:5px;" |
   |-
-   | style="padding:5px;" |
+   ! style="padding:5px;" |
    | style="padding:5px; width:1200px;" |'''1.3.301''' The system can manage and store media objects like digital photos, bitmaps, movies, and audio files.
   |-
@@ Line 561: / Line 561: @@
    | style="background-color:white; padding:5px;" |
   |-
-   | style="padding:5px;" |
+   ! style="padding:5px;" |
    | style="padding:5px; width:1200px;" |'''1.3.302''' The system allows multiple native instruments and users to enter data into the system simultaneously without disruption.
   |-
@@ Line 567: / Line 567: @@
    | style="background-color:white; padding:5px;" |
   |-
-   | style="padding:5px;" |
+   ! style="padding:5px;" |
    | style="padding:5px; width:1200px;" |'''1.3.303''' The system can interface with and [[LIMS feature#Import data|import existing data]] from other databases and file shares.
   |-
@@ Line 573: / Line 573: @@
    | style="background-color:white; padding:5px;" |
   |-
-   | style="padding:5px;" |
+   ! style="padding:5px;" |
    | style="padding:5px; width:1200px;" |'''1.3.304''' The system supports data capture from a Citrix-based environment.
   |-
@@ Line 579: / Line 579: @@
    | style="background-color:white; padding:5px;" |
   |-
-   | style="padding:5px;" |
+   ! style="padding:5px;" |
    | style="padding:5px; width:1200px;" |'''1.3.305''' The system allows file indexes to be stored centrally while associated files are stored geographically.
   |-
@@ Line 585: / Line 585: @@
    | style="background-color:white; padding:5px;" |
   |-
-   | style="padding:5px;" |
+   ! style="padding:5px;" |
    | style="padding:5px; width:1200px;" |'''1.3.306''' The system allows users to organize captured data by project, date, location, instrument, etc.
   |-
@@ Line 591: / Line 591: @@
    | style="background-color:white; padding:5px;" |
   |-
-   | style="padding:5px;" |
+   ! style="padding:5px;" |
    | style="padding:5px; width:1200px;" |'''1.3.307''' The system can route captured data based upon specified metadata tags.
   |-
@@ Line 597: / Line 597: @@
    | style="background-color:white; padding:5px;" |
   |-
-   | style="padding:5px;" |
+   ! style="padding:5px;" |
    | style="padding:5px; width:1200px;" |'''1.3.308''' The system allows full on-screen review and approval of native instrument data prior to database commitment.
   |-
@@ Line 603: / Line 603: @@
    | style="background-color:white; padding:5px;" |
   |-
-   | style="padding:5px;" |
+   ! style="padding:5px;" |
    | style="padding:5px; width:1200px;" |'''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.
   |-
@@ Line 609: / Line 609: @@
    | style="background-color:white; padding:5px;" |
   |-
-   | style="padding:5px;" |
+   ! style="padding:5px;" |
    | style="padding:5px; width:1200px;" |'''1.3.310''' The system has a tool that allows users to capture data printed to it as a searchable PDF file.
   |-
@@ Line 615: / Line 615: @@
    | style="background-color:white; padding:5px;" |
   |-
-   | style="padding:5px;" |
+   ! style="padding:5px;" |
    | style="padding:5px; width:1200px;" |'''1.3.311''' The system can automatically normalize and store incoming data to a technology-neutral format like XML.
   |-
@@ Line 621: / Line 621: @@
    | style="background-color:white; padding:5px;" |
   |-
-   | style="padding:5px;" |
+   ! style="padding:5px;" |
    | style="padding:5px; width:1200px;" |'''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.
   |-
@@ Line 627: / Line 627: @@
    | style="background-color:white; padding:5px;" |
   |-
-   | style="padding:5px;" |
+   ! style="padding:5px;" |
    | style="padding:5px; width:1200px;" |'''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.
   |-
@@ Line 633: / Line 633: @@
    | style="background-color:white; padding:5px;" |
   |-
-   | style="padding:5px;" |
+   ! style="padding:5px;" |
    | style="padding:5px; width:1200px;" |'''1.3.314''' The system allows users to manually upload instrument data files that are not part of a scheduled upload.
   |-
@@ Line 639: / Line 639: @@
    | style="background-color:white; padding:5px;" |
   |-
-   | style="padding:5px;" |
+   ! style="padding:5px;" |
    | style="padding:5px; width:1200px;" |'''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.
   |-
@@ Line 645: / Line 645: @@
    | style="background-color:white; padding:5px;" |
   |-
-   | style="padding:5px;" |
+   ! style="padding:5px;" |
    | style="padding:5px; width:1200px;" |'''1.3.316''' The system can remove data from client machines upon upload and/or backup, based on a schedule or retention policy.
   |-
@@ Line 651: / Line 651: @@
    | style="background-color:white; padding:5px;" |
   |-
-   | style="padding:5px;" |
+   ! style="padding:5px;" |
    | style="padding:5px; width:1200px;" |'''1.3.317''' The system allows users to review, restore, and reprocess original native instrument data on the original instrument acquisition software.
   |-
@@ Line 657: / Line 657: @@
    | style="background-color:white; padding:5px;" |
   |-
-   | style="padding:5px;" |
+   ! style="padding:5px;" |
    | style="padding:5px; width:1200px;" |'''1.3.318''' The system allows users to open and view captured native instrument files without restoring them.
   |-
@@ Line 663: / Line 663: @@
    | style="background-color:white; padding:5px;" |
   |-
-   | style="padding:5px;" |
+   ! style="padding:5px;" |
    | style="padding:5px; width:1200px;" |'''1.3.319''' The system allows captured processed data to be reused by other applications without having to reprocess it.
   |-
@@ Line 669: / Line 669: @@
    | style="background-color:white; padding:5px;" |
   |-
-   | style="padding:5px;" |
+   ! style="padding:5px;" |
    | style="padding:5px; width:1200px;" |'''1.3.320''' The system provides a method to extract data points from captured processed data and present it in a human-readable format.
   |-
@@ Line 675: / Line 675: @@
    | style="background-color:white; padding:5px;" |
   |-
-   | style="padding:5px;" |
+   ! style="padding:5px;" |
    | style="padding:5px; width:1200px;" |'''1.3.321''' The system can parse captured data files containing specified metadata into a live results table.
   |-
@@ Line 691: / Line 691: @@
    ! style="color:brown; background-color:#ffffee; width:1200px;"| Requirement # and requirement
   |-
-   | style="padding:5px;" |
+   ! style="padding:5px;" |
    | style="padding:5px; width:1200px;" |'''1.3.400''' The system provides data archiving functionality for all contained data, without requiring an off-line mode.
   |-
@@ Line 697: / Line 697: @@
    | style="background-color:white; padding:5px;" |
   |-
-   | style="padding:5px;" |
+   ! style="padding:5px;" |
    | style="padding:5px; width:1200px;" |'''1.3.401''' The system allows for a configurable scheduled archive, not requiring human interaction with the data to be archived.
   |-
@@ Line 703: / Line 703: @@
    | style="background-color:white; padding:5px;" |
   |-
-   | style="padding:5px;" |
+   ! style="padding:5px;" |
    | style="padding:5px; width:1200px;" |'''1.3.402''' The system allows for a scheduled archive of data directly captured from a specific native instrument.
   |-
@@ Line 709: / Line 709: @@
    | style="background-color:white; padding:5px;" |
   |-
-   | style="padding:5px;" |
+   ! style="padding:5px;" |
    | style="padding:5px; width:1200px;" |'''1.3.403''' The system permits native instrument data to be archived and restored with its original directory structure.
   |-
@@ Line 715: / Line 715: @@
    | style="background-color:white; padding:5px;" |
   |-
-   | style="padding:5px;" |
+   ! style="padding:5px;" |
    | style="padding:5px; width:1200px;" |'''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.
   |-
@@ Line 721: / Line 721: @@
    | style="background-color:white; padding:5px;" |
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-   | style="padding:5px;" |
+   ! style="padding:5px;" |
    | style="padding:5px; width:1200px;" |'''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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@@ Line 727: / Line 727: @@
    | style="background-color:white; padding:5px;" |
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-   | style="padding:5px;" |
+   ! style="padding:5px;" |
    | style="padding:5px; width:1200px;" |'''1.3.406''' The system can perform archive and restore functions simultaneously with data capture and viewing functions, without disruption.
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@@ Line 733: / Line 733: @@
    | style="background-color:white; padding:5px;" |
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-   | style="padding:5px;" |
+   ! style="padding:5px;" |
    | style="padding:5px; width:1200px;" |'''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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@@ Line 749: / Line 749: @@
    ! style="color:brown; background-color:#ffffee; width:1200px;"| Requirement # and requirement
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-   | style="padding:5px;" |
+   ! style="padding:5px;" |
    | style="padding:5px; width:1200px;" |'''1.3.500''' The system bilaterally [[LIMS feature#Instrument interfacing and management|interfaces]] with instruments and related software based on the Unix and Windows platforms.
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@@ Line 755: / Line 755: @@
    | style="background-color:white; padding:5px;" |
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-   | style="padding:5px;" |
+   ! style="padding:5px;" |
    | style="padding:5px; width:1200px;" |'''1.3.501''' The system can download data directly from laboratory instruments.
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@@ Line 761: / Line 761: @@
    | style="background-color:white; padding:5px;" |
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-   | style="padding:5px;" |
+   ! style="padding:5px;" |
    | style="padding:5px; width:1200px;" |'''1.3.502''' The system can track and report on the usage of attached laboratory instruments.
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@@ Line 767: / Line 767: @@
    | style="background-color:white; padding:5px;" |
   |-
-   | style="padding:5px;" |
+   ! style="padding:5px;" |
    | style="padding:5px; width:1200px;" |'''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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@@ Line 773: / Line 773: @@
    | style="background-color:white; padding:5px;" |
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-   | style="padding:5px;" |
+   ! style="padding:5px;" |
    | style="padding:5px; width:1200px;" |'''1.3.504''' The system maintains a reportable database of preventative maintenance, calibration, and repair records for attached laboratory instruments.
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@@ Line 779: / Line 779: @@
    | style="background-color:white; padding:5px;" |
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-   | style="padding:5px;" |
+   ! style="padding:5px;" |
    | style="padding:5px; width:1200px;" |'''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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@@ Line 785: / Line 785: @@
    | style="background-color:white; padding:5px;" |
   |-
-   | style="padding:5px;" |
+   ! style="padding:5px;" |
    | style="padding:5px; width:1200px;" |'''1.3.506''' The system allows users to create and edit instrument maintenance profiles.
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@@ Line 801: / Line 801: @@
    ! style="color:brown; background-color:#ffffee; width:1200px;"| Requirement # and requirement
   |-
-   | style="padding:5px;" |
+   ! style="padding:5px;" |
    | style="padding:5px; width:1200px;" |'''1.3.600.''' The system supports a library of common electronic data deliverable (EDD) formats.
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@@ Line 807: / Line 807: @@
    | style="background-color:white; padding:5px;" |
   |-
-   | style="padding:5px;" |
+   ! style="padding:5px;" |
    | style="padding:5px; width:1200px;" |'''1.3.601''' The system can transfer data to and from other record management systems.
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@@ Line 813: / Line 813: @@
    | style="background-color:white; padding:5px;" |
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-   | style="padding:5px;" |
+   ! style="padding:5px;" |
    | style="padding:5px; width:1200px;" |'''1.3.602''' The system [[LIS feature#Third-party software integration|integrates]] with Microsoft Exchange services.
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@@ Line 819: / Line 819: @@
    | style="background-color:white; padding:5px;" |
   |-
-   | style="padding:5px;" |
+   ! style="padding:5px;" |
    | style="padding:5px; width:1200px;" |'''1.3.603''' The system can [[LIMS feature#Import data|import data]] from and export data to Microsoft Word, Excel, Access, and/or Powerpoint.
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@@ Line 825: / Line 825: @@
    | style="background-color:white; padding:5px;" |
   |-
-   | style="padding:5px;" |
+   ! style="padding:5px;" |
    | style="padding:5px; width:1200px;" |'''1.3.604''' The system can interface with non-Microsoft programs.
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@@ Line 831: / Line 831: @@
    | style="background-color:white; padding:5px;" |
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-   | style="padding:5px;" |
+   ! style="padding:5px;" |
    | style="padding:5px; width:1200px;" |'''1.3.605''' The system can interface with enterprise resource planning (ERP) systems.
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@@ Line 837: / Line 837: @@
    | style="background-color:white; padding:5px;" |
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-   | style="padding:5px;" |
+   ! style="padding:5px;" |
    | style="padding:5px; width:1200px;" |'''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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@@ Line 843: / Line 843: @@
    | style="background-color:white; padding:5px;" |
   |-
-   | style="padding:5px;" |
+   ! style="padding:5px;" |
    | style="padding:5px; width:1200px;" |'''1.3.607''' The system can leverage the application programming interface (API) of other systems to establish integration between systems.
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    | style="background-color:white; padding:5px;" |
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-   | style="padding:5px;" |
+   ! style="padding:5px;" |
    | style="padding:5px; width:1200px;" |'''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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@@ Line 855: / Line 855: @@
    | style="background-color:white; padding:5px;" |
   |-
-   | style="padding:5px;" |
+   ! style="padding:5px;" |
    | style="padding:5px; width:1200px;" |'''1.3.609''' The system supports [[LIMS feature#Mobile device integration|dockable mobile devices]] and handles information exchange between them and the system.
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@@ Line 861: / Line 861: @@
    | style="background-color:white; padding:5px;" |
   |-
-   | style="padding:5px;" |
+   ! style="padding:5px;" |
    | style="padding:5px; width:1200px;" |'''1.3.610''' The system supports the use of optical character recognition (OCR) software.
   |-
@@ Line 877: / Line 877: @@
    ! style="color:brown; background-color:#ffffee; width:1200px;"| Requirement # and requirement
   |-
-   | style="padding:5px;" |
+   ! style="padding:5px;" |
    | style="padding:5px; width:1200px;" |'''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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@@ Line 883: / Line 883: @@
    | style="background-color:white; padding:5px;" |
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-   | style="padding:5px;" |
+   ! style="padding:5px;" |
    | style="padding:5px; width:1200px;" |'''1.3.701''' The system can interface with a third-party reporting application.
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@@ Line 889: / Line 889: @@
    | style="background-color:white; padding:5px;" |
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-   | style="padding:5px;" |
+   ! style="padding:5px;" |
    | style="padding:5px; width:1200px;" |'''1.3.702''' The system allows the development of [[LIMS feature#Custom reporting|custom templates]] for different types of reports.
   |-
@@ Line 895: / Line 895: @@
    | style="background-color:white; padding:5px;" |
   |-
-   | style="padding:5px;" |
+   ! style="padding:5px;" |
    | style="padding:5px; width:1200px;" |'''1.3.703''' The system maintains template versions and renditions, allowing management and tracking of the template over time.
   |-
@@ Line 901: / Line 901: @@
    | style="background-color:white; padding:5px;" |
   |-
-   | style="padding:5px;" |
+   ! style="padding:5px;" |
    | style="padding:5px; width:1200px;" |'''1.3.704''' The system uses Microsoft Office tools for formatting reports.
   |-
@@ Line 907: / Line 907: @@
    | style="background-color:white; padding:5px;" |
   |-
-   | style="padding:5px;" |
+   ! style="padding:5px;" |
    | style="padding:5px; width:1200px;" |'''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.
   |-
@@ Line 913: / Line 913: @@
    | style="background-color:white; padding:5px;" |
   |-
-   | style="padding:5px;" |
+   ! style="padding:5px;" |
    | style="padding:5px; width:1200px;" |'''1.3.706''' The system makes graphic and tabular data vector-scalable in reports.
   |-
@@ Line 919: / Line 919: @@
    | style="background-color:white; padding:5px;" |
   |-
-   | style="padding:5px;" |
+   ! style="padding:5px;" |
    | style="padding:5px; width:1200px;" |'''1.3.707''' The system allows for internal hyperlinking to source data in reports.
   |-
@@ Line 925: / Line 925: @@
    | style="background-color:white; padding:5px;" |
   |-
-   | style="padding:5px;" |
+   ! style="padding:5px;" |
    | style="padding:5px; width:1200px;" |'''1.3.708''' The system allows users to manually adjust inaccurate data parsing routines for reports.
   |-
@@ Line 931: / Line 931: @@
    | style="background-color:white; padding:5px;" |
   |-
-   | style="padding:5px;" |
+   ! style="padding:5px;" |
    | style="padding:5px; width:1200px;" |'''1.3.709''' The system can indicate whether a report is preliminary, amended, corrected, or final while retaining revision history.
   |-
@@ Line 937: / Line 937: @@
    | style="background-color:white; padding:5px;" |
   |-
-   | style="padding:5px;" |
+   ! style="padding:5px;" |
    | style="padding:5px; width:1200px;" |'''1.3.710''' The system can automatically generate laboratory reports of findings and other written documents.
   |-
@@ Line 943: / Line 943: @@
    | style="background-color:white; padding:5px;" |
   |-
-   | style="padding:5px;" |
+   ! style="padding:5px;" |
    | style="padding:5px; width:1200px;" |'''1.3.711''' The system provides an ad-hoc web reporting interface to report on user-selected criteria.
   |-
@@ Line 949: / Line 949: @@
    | style="background-color:white; padding:5px;" |
   |-
-   | style="padding:5px;" |
+   ! style="padding:5px;" |
    | style="padding:5px; width:1200px;" |'''1.3.712''' The system can automatically generate and post periodic static summary reports on an internal web server.
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@@ Line 955: / Line 955: @@
    | style="background-color:white; padding:5px;" |
   |-
-   | style="padding:5px;" |
+   ! style="padding:5px;" |
    | style="padding:5px; width:1200px;" |'''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.
   |-
@@ Line 961: / Line 961: @@
    | style="background-color:white; padding:5px;" |
   |-
-   | style="padding:5px;" |
+   ! style="padding:5px;" |
    | style="padding:5px; width:1200px;" |'''1.3.714''' The system supports PDF/A, an ISO-standardized version of the Portable Document Format (PDF).
   |-
@@ Line 967: / Line 967: @@
    | style="background-color:white; padding:5px;" |
   |-
-   | style="padding:5px;" |
+   ! style="padding:5px;" |
    | style="padding:5px; width:1200px;" |'''1.3.715''' The system includes a rules engine to determine the recipients of reports and other documents based on definable parameters.
   |-
@@ Line 973: / Line 973: @@
    | style="background-color:white; padding:5px;" |
   |-
-   | style="padding:5px;" |
+   ! style="padding:5px;" |
    | style="padding:5px; width:1200px;" |'''1.3.716''' The system provides printer-friendly audit trails for cleaner reporting of audit data.
   |-
@@ Line 979: / Line 979: @@
    | style="background-color:white; padding:5px;" |
   |-
-   | style="padding:5px;" |
+   ! style="padding:5px;" |
    | style="padding:5px; width:1200px;" |'''1.3.717''' The system provides an interface for external clients to search, generate, and view processed data reports based on metadata tags.
   |-
@@ Line 985: / Line 985: @@
    | style="background-color:white; padding:5px;" |
   |-
-   | style="padding:5px;" |
+   ! style="padding:5px;" |
    | style="padding:5px; width:1200px;" |'''1.3.718''' The system provides document workflow management tools for streamlining their creation, review, modification, and approval.
   |-