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

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<div class="nonumtoc">__TOC__</div>
{{ombox
| type      = notice
| style    = width: 960px;
| text      = This is sublevel1 of my sandbox, where I play with features and test MediaWiki code. If you wish to leave a comment for me, please see [[User_talk:Shawndouglas|my discussion page]] instead.<p></p>
}}


==Sandbox begins below==
==The laws themselves==


* '''Y''': Meets requirement in commercial off-the-shelf solution as delivered/configured (or vendor provides service)
===1. Federal Telecommunications Act of 1996, Section 255 ([https://www.law.cornell.edu/uscode/text/47/255 47 U.S.C. § 255 - Access by persons with disabilities])===
* '''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


<blockquote>'''(b) Manufacturing'''
A manufacturer of telecommunications equipment or customer premises equipment shall ensure that the equipment is designed, developed, and fabricated to be accessible to and usable by individuals with disabilities, if readily achievable.


'''(c) Telecommunications services'''


==1.0 Demonstration==
A provider of telecommunications service shall ensure that the service is accessible to and usable by individuals with disabilities, if readily achievable.
{|
| STYLE="vertical-align:top;"|
{| class="wikitable collapsible" border="1" cellpadding="10" cellspacing="0"
|-
  ! colspan="3" style="text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;"| 1.0 '''Demonstration'''
|-
  ! style="color:brown; background-color:#ffffee; width:500px;"| Request for information
  ! style="color:brown; background-color:#ffffee; width:100px;"| Requirement code
  ! style="color:brown; background-color:#ffffee; width:700px;"| Vendor response
|-
  | style="padding:5px; width:500px;" |'''1.0-000''' The vendor offers an online and/or on-site demonstration.
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
|}
|}


==1.1 Information technology==
'''(d) Compatibility'''
{|
Whenever the requirements of subsections (b) and (c) are not readily achievable, such a manufacturer or provider shall ensure that the equipment or service is compatible with existing peripheral devices or specialized customer premises equipment commonly used by individuals with disabilities to achieve access, if readily achievable.</blockquote>
| STYLE="vertical-align:top;"|
===1.1.1 General IT===
{| class="wikitable collapsible" border="1" cellpadding="10" cellspacing="0"
|-
  ! colspan="3" style="color:DarkSlateGray; text-align:left; padding-left:40px;"| 1.1.1 '''General IT'''
|-
  ! style="color:brown; background-color:#ffffee; width:500px;"| Request for information
  ! style="color:brown; background-color:#ffffee; width:100px;"| Requirement code
  ! style="color:brown; background-color:#ffffee; width:700px;"| Vendor response
|-
  | style="padding:5px; width:500px;" |'''1.1-100''' The system operates with a traditional client-server architecture, with software installed on each machine that needs to access the system.
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''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.
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''1.1-103''' The system contains a single, centralized database that supports multiple sites and departments.
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''1.1-104''' The system's database conforms to the [[ODBC|Open Database Connectivity Standard]] (ODBC).
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''1.1-105''' The system is designed so upgrades to the back-end database do not require extensive reconfiguration or effectively cripple the system.
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''1.1-106''' The system is designed to not be impacted by multiple users or failover processes.
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''1.1-107''' The system applies security features to all system files.
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''1.1-108''' The system applies log-in security to all servers and workstations accessing it.
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''1.1-109''' The system provides a workstation and server authentication mechanism.
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''1.1-110''' The system applies Secured Socket Layer (SSL) encryption on the web client interface.
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''1.1-111''' The system encrypts client passwords in a database, with support for multi-case and special characters.
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''1.1-112''' The system uses TCP/IP as its network transport.
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''1.1-113''' The system allows automated backup and restore capability without support intervention, as well as manual backups.
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''1.1-114''' The system maintains the transactional history of system administrators.
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
|}


===1.1.2 Hardware environment===
The term '''disability''' is [https://www.law.cornell.edu/uscode/text/42/12102 defined here]. You can read the full entry, but the basics are:
{| class="wikitable collapsible" border="1" cellpadding="10" cellspacing="0"
|-
  ! colspan="3" style="color:DarkSlateGray;text-align:left; padding-left:40px;"| 1.1.2 '''Hardware environment'''
|-
  ! style="color:brown; background-color:#ffffee; width:500px;"| Request for information
  ! style="color:brown; background-color:#ffffee; width:100px;"| Requirement code
  ! style="color:brown; background-color:#ffffee; width:700px;"| Vendor response
|-
  | style="padding:5px; width:500px;" |'''1.1-200''' The system proves compatible with a variety of hardware environments.
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''1.1-201''' The system can be utilized with a touch-screen.
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
|}


===1.1.3 Software environment===
<blockquote>'''(1) Disability''' The term “disability” means, with respect to an individual—
{| class="wikitable collapsible" border="1" cellpadding="10" cellspacing="0"
:'''(A)''' a physical or mental impairment that substantially limits one or more major life activities of such individual;
|-
  ! colspan="3" style="color:DarkSlateGray;text-align:left; padding-left:40px;"| 1.1.3 '''Software environment'''
|-
  ! style="color:brown; background-color:#ffffee; width:500px;"| Request for information
  ! style="color:brown; background-color:#ffffee; width:100px;"| Requirement code
  ! style="color:brown; background-color:#ffffee; width:700px;"| Vendor response
|-
  | style="padding:5px; width:500px;" |'''1.1-300''' The system proves compatible with a variety of software environments.
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''1.1-301''' The system utilizes a non-proprietary database such as Oracle or Microsoft SQL Server.
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
|}
|}


==1.2 Regulatory compliance and security==
:'''(B)''' a record of such an impairment; or
{|
| STYLE="vertical-align:top;"|
===1.2.1 Regulatory compliance===
{| class="wikitable collapsible" border="1" cellpadding="10" cellspacing="0"
|-
  ! colspan="3" style="color:DarkSlateGray; text-align:left; padding-left:40px;"| 1.2.1 '''Regulatory compliance'''
|-
  ! style="color:brown; background-color:#ffffee; width:500px;"| Request for information
  ! style="color:brown; background-color:#ffffee; width:100px;"| Requirement code
  ! style="color:brown; background-color:#ffffee; width:700px;"| Vendor response
|-
  | style="padding:5px; width:500px;" |'''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.
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''b.''' 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.
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''c.''' The system supports USP <232>/<233> requirements.
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''d.''' The system supports [[GALP]] and/or [[GAMP]] standards.
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|- 
  | style="padding:5px; width:500px;" |'''e.''' The system supports the U.S. DoD 5015.2 Standard.
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''f.''' 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.
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''g.''' The system audit log retains all data, prohibits any deletions, and allows user comments.
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''h.''' The system maintains audit trails at least as long as the records to which they pertain.
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''i.''' The system provides additional persistent auditing capabilities, such as the audit of cancelled uploads and scheduled system functions.
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''j.''' The system provides the ability to both automatically and manually add secure [[ELN feature#Electronic signatures|electronic signatures]] to documents and other data.
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''k.''' The system can automatically validate and approve data prior to being moved to the main database.
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
|}


===1.3.2 Security===
:'''(C)''' being regarded as having such an impairment (as described in paragraph (3)).</blockquote>
{| class="wikitable collapsible" border="1" cellpadding="10" cellspacing="0"
|-
  ! colspan="3" style="color:DarkSlateGray;text-align:left; padding-left:40px;"| 1.3.2 '''Security'''
|-
  ! style="color:brown; background-color:#ffffee; width:500px;"| Request for information
  ! style="color:brown; background-color:#ffffee; width:100px;"| Requirement code
  ! style="color:brown; background-color:#ffffee; width:700px;"| Vendor response
|-
  | style="padding:5px; width:500px;" |'''a.''' 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.
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''b.''' The system allows administrators and users to reset user passwords.
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''c.''' The system features and enforces adjustable rules concerning password complexity, reuse, and expiration.
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''d.''' The system can lock a user out after a specified number of consecutive failed log-in attempts.
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''e.''' The system provides the option for automatic user logout based on keyboard or mouse inactivity.
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''f.''' The system makes authority checks to ensure only authorized individuals can use the system to perform an operation.
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''g.''' The system allows authorized users to modify records, while also maintaining an audit trail of such actions.
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''h.''' The system allows authorized users to manually delete records, while also maintaining an audit trail of such actions.
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''i.''' The system prompts users to declare a reason for making changes to or deleting data in the system.
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''j.''' The system allows authorized users to generate a detailed user access record.
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''k.''' The system provides email notification of lockout, security access, and improper workstation access.
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''l.''' The system provides a mechanism to allow a user read-only access to stored data.
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''m.''' 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.
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''n.''' 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.
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''o.''' 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.
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''p.''' The system employs automatic file encryption on stored data.
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''q.''' The system employs checks to enforce permitted sequencing of steps and events.
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
|}
|}


==1.4 General system functions==
The term '''readily achievable''' is [https://www.law.cornell.edu/uscode/text/42/12181 defined here]. It is defines as:
{|
| STYLE="vertical-align:top;"|
===1.4.1 General functions===
{| class="wikitable collapsible" border="1" cellpadding="10" cellspacing="0"
|-
  ! colspan="3" style="color:DarkSlateGray; text-align:left; padding-left:40px;"| 1.4.1 '''General functions'''
|-
  ! style="color:brown; background-color:#ffffee; width:500px;"| Request for information
  ! style="color:brown; background-color:#ffffee; width:100px;"| Requirement code
  ! style="color:brown; background-color:#ffffee; width:700px;"| Vendor response
|-
  | style="padding:5px; width:500px;" |'''a.''' 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.
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''b.''' The system allows authorized users to configure their GUI to a specific language, character set, and time zone.
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''c.''' The system permits remote access for users, system admins, and support agents.
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''d.''' The system allows for the use of navigation keys to freely move from field to field.
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''e.''' The system allows tabular data to be sorted and filtered.
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''f.''' The system can send on-screen output to a printer or file without contradicting view-only statuses.
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''g.''' The system contains one or more spell-check dictionaries that allow authorized users to add, edit, or remove entries.
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''h.''' The system uses human-readable metadata tags to better describe, index, and store all captured and archived data.
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''i.''' The system can generate metadata tags via derived value rules.
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''j.''' The system allows users to manually add metadata tags to files.
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''k.''' The system provides full metadata, keyword, and field [[LIMS feature#Query capability|search capability]], including the use of multiple search criteria.
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''l.''' The system allows users to search for similar records based upon a set of metadata tag values.
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''m.''' The system allows users to build, save, and edit queries for future use.
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''n.''' 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.
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''o.''' The system allows users to attach comments to data and files.
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''p.''' The system's file viewer/explorer allow users to view native, processed, and archived data in its native file structure.
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''q.''' The system can link objects to other objects, e.g. linking a standard operating procedure (SOP) to a test result.
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''r.''' The system [[LIMS feature#Alarms and/or alerts|notifies users]] of events like the scheduling and completion of tasks.
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''s.''' The system includes the ability to set up alerts via email.
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''t.''' The system offers integrated or online user help screens.
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''u.''' The system includes data analysis and calculation tools.
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
|}


===1.4.2 Configuration and customization===
<blockquote>'''(9) Readily achievable''' The term “readily achievable” means easily accomplishable and able to be carried out without much difficulty or expense. In determining whether an action is readily achievable, factors to be considered include—
{| class="wikitable collapsible" border="1" cellpadding="10" cellspacing="0"
|-
  ! colspan="3" style="color:DarkSlateGray;text-align:left; padding-left:40px;"| 1.4.2 '''Configuration and customization'''
|-
  ! style="color:brown; background-color:#ffffee; width:500px;"| Request for information
  ! style="color:brown; background-color:#ffffee; width:100px;"| Requirement code
  ! style="color:brown; background-color:#ffffee; width:700px;"| Vendor response
|-
  | style="padding:5px; width:500px;" |'''a.''' 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.
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''b.''' 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.
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''c.''' 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.
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''d.''' The system allows for the integration of additional printers and scanners both locally and externally.
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
|}


===1.4.3 Data capture===
:'''(A)''' the nature and cost of the action needed under this chapter;
{| class="wikitable collapsible" border="1" cellpadding="10" cellspacing="0"
:'''(B)''' the overall financial resources of the facility or facilities involved in the action; the number of persons employed at such facility; the effect on expenses and resources, or the impact otherwise of such action upon the operation of the facility;
|-
:'''(C)''' the overall financial resources of the covered entity; the overall size of the business of a covered entity with respect to the number of its employees; the number, type, and location of its facilities; and
  ! colspan="3" style="color:DarkSlateGray;text-align:left; padding-left:40px;"| 1.4.3 '''Data capture'''
:'''(D)''' the type of operation or operations of the covered entity, including the composition, structure, and functions of the workforce of such entity; the geographic separateness, administrative or fiscal relationship of the facility or facilities in question to the covered entity.</blockquote>
|-
  ! style="color:brown; background-color:#ffffee; width:500px;"| Request for information
  ! style="color:brown; background-color:#ffffee; width:100px;"| Requirement code
  ! style="color:brown; background-color:#ffffee; width:700px;"| Vendor response
|-
  | style="padding:5px; width:500px;" |'''a.''' 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.
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''b.''' The system can manage and store media objects like digital photos, bitmaps, movies, and audio files.
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''c.''' The system allows multiple native instruments and users to enter data into the system simultaneously without disruption.
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''d.''' The system can interface with and [[LIMS feature#Import data|import existing data]] from other databases and file shares.
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''e.''' The system supports data capture from a Citrix-based environment.
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''f.''' The system allows file indexes to be stored centrally while associated files are stored geographically.
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''g.''' The system allows users to organize captured data by project, date, location, instrument, etc.
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''h.''' The system can route captured data based upon specified metadata tags.
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''i.''' The system allows full on-screen review and approval of native instrument data prior to database commitment.
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''j.''' 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.
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''k.''' The system has a tool that allows users to capture data printed to it as a searchable PDF file.
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''l.''' The system can automatically normalize and store incoming data to a technology-neutral format like XML.
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''m.''' The system allows incoming and entered files to be converted into other open formats like JCAMP-DX, TraML, mzML, mzXML, AnIML, pepXML, and protXML.
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''n.''' 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.
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''o.''' The system allows users to manually upload instrument data files that are not part of a scheduled upload.
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''p.''' 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.
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''q.''' The system can remove data from client machines upon upload and/or backup, based on a schedule or retention policy.
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''r.''' The system allows users to review, restore, and reprocess original native instrument data on the original instrument acquisition software.
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''s.''' The system allows users to open and view captured native instrument files without restoring them.
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''t.''' The system allows captured processed data to be reused by other applications without having to reprocess it.
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''u.''' The system provides a method to extract data points from captured processed data and present it in a human-readable format.
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''v.''' The system can parse captured data files containing specified metadata into a live results table.
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
|}


===1.4.4 Data archiving and migration===
===2. Rehabilitation Act of 1973, Section 508, amended ([https://www.law.cornell.edu/uscode/text/29/794d 29 U.S.C. 794d] - Electronic and information technology)===
{| class="wikitable collapsible" border="1" cellpadding="10" cellspacing="0"
|-
  ! colspan="3" style="color:DarkSlateGray;text-align:left; padding-left:40px;"| 1.4.4 '''Data archiving and migration'''
|-
  ! style="color:brown; background-color:#ffffee; width:500px;"| Request for information
  ! style="color:brown; background-color:#ffffee; width:100px;"| Requirement code
  ! style="color:brown; background-color:#ffffee; width:700px;"| Vendor response
|-
  | style="padding:5px; width:500px;" |'''a.''' The system provides data archiving functionality for all contained data, without requiring an off-line mode.
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''b.''' The system allows for a configurable scheduled archive, not requiring human interaction with the data to be archived.
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''c.''' The system allows for a scheduled archive of data directly captured from a specific native instrument.
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''d.''' The system permits native instrument data to be archived and restored with its original directory structure.
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''e.''' 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.
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''f.''' The system ensures that held or locked native instrument data not captured during a scheduled archive will be captured during the next scheduled archive.
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''g.''' The system can perform archive and restore functions simultaneously with data capture and viewing functions, without disruption.
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''h.''' The system allows native instrument and processed data migrated from an old SDMS version to be backed up and restored without alteration.
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
|}


===1.4.5 Instruments===
There's a government website dedicated to Section 508: [https://www.section508.gov/ https://www.section508.gov/] The related laws and polices can be [https://www.section508.gov/manage/laws-and-policies/ found here]. The intro states (italics emphasis mine):
{| class="wikitable collapsible" border="1" cellpadding="10" cellspacing="0"
|-
  ! colspan="3" style="color:DarkSlateGray;text-align:left; padding-left:40px;"| 1.4.5 '''Instruments'''
|-
  ! style="color:brown; background-color:#ffffee; width:500px;"| Request for information
  ! style="color:brown; background-color:#ffffee; width:100px;"| Requirement code
  ! style="color:brown; background-color:#ffffee; width:700px;"| Vendor response
|-
  | style="padding:5px; width:500px;" |'''a.''' The system bilaterally [[LIMS feature#Instrument interfacing and management|interfaces]] with instruments and related software based on the Unix and Windows platforms.
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''b.''' The system can download data directly from laboratory instruments.
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''c.''' The system can track and report on the usage of attached laboratory instruments.
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''d.''' 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.
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''e.''' The system maintains a reportable database of preventative maintenance, calibration, and repair records for attached laboratory instruments.
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''f.''' The system can schedule calibration, verification, and maintenance tasks on attached instruments and make that schedule available for viewing.
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''g.''' The system allows users to create and edit instrument maintenance profiles.
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
|}


===1.4.6 External system interfaces===
<blockquote>In 1998, Congress amended the Rehabilitation Act of 1973 to require Federal agencies to make their electronic and information technology (EIT) accessible to people with disabilities. The law (29 U.S.C § 794 (d)) ''applies to all Federal agencies when they develop, procure, maintain, or use electronic and information technology''. Under Section 508, agencies must give ''disabled employees and members of the public'' access to information comparable to the access available to others.
{| class="wikitable collapsible" border="1" cellpadding="10" cellspacing="0"
|-
  ! colspan="3" style="color:DarkSlateGray;text-align:left; padding-left:40px;"| 1.4.6 '''External system interfaces'''
|-
  ! style="color:brown; background-color:#ffffee; width:500px;"| Request for information
  ! style="color:brown; background-color:#ffffee; width:100px;"| Requirement code
  ! style="color:brown; background-color:#ffffee; width:700px;"| Vendor response
|-
  | style="padding:5px; width:500px;" |'''a.''' The system supports a library of common electronic data deliverable (EDD) formats.
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''b.''' The system can transfer data to and from other record management systems.
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''c.''' The system [[LIS feature#Third-party software integration|integrates]] with Microsoft Exchange services.
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''d.''' The system can [[LIMS feature#Import data|import data]] from and export data to Microsoft Word, Excel, Access, and/or Powerpoint.
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''e.''' The system can interface with non-Microsoft programs.
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''f.''' The system can interface with enterprise resource planning (ERP) systems.
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''g.''' The system can interface with internal and external laboratory systems like laboratory information management systems (LIMS) and electronic laboratory notebooks (ELNs).
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''h.''' The system can leverage the application programming interface (API) of other systems to establish integration between systems.
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''i.''' The system provides a real-time interface for viewing live and stored data transactions and errors generated by interfaced instruments and systems.
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''j.''' The system supports [[LIMS feature#Mobile device integration|dockable mobile devices]] and handles information exchange between them and the system.
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''k.''' The system supports the use of optical character recognition (OCR) software.
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
|}


===1.4.7 Reporting===
The [https://www.access-board.gov/ U.S. Access Board] is responsible for developing Information and Communication Technology (ICT) accessibility ''standards'' to ''incorporate into regulations that govern Federal procurement practices.'' On January 18, 2017, the Access Board issued a final rule that updated accessibility requirements covered by Section 508, and refreshed guidelines for telecommunications equipment subject to Section 255 of the Communications Act. The final rule went into effect on January 18, 2018.
{| class="wikitable collapsible" border="1" cellpadding="10" cellspacing="0"
|-
  ! colspan="3" style="color:DarkSlateGray;text-align:left; padding-left:40px;"| 1.4.7 '''Reporting'''
|-
  ! style="color:brown; background-color:#ffffee; width:500px;"| Request for information
  ! style="color:brown; background-color:#ffffee; width:100px;"| Requirement code
  ! style="color:brown; background-color:#ffffee; width:700px;"| Vendor response
|-
  | style="padding:5px; width:500px;" |'''a.''' The system includes a versatile report writer and forms generator that can generate reports from any data in the system.
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''b.''' The system can interface with a third-party reporting application.
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''c.''' The system allows the development of [[LIMS feature#Custom reporting|custom templates]] for different types of reports.
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''d.''' The system maintains template versions and renditions, allowing management and tracking of the template over time.
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''e.''' The system uses Microsoft Office tools for formatting reports.
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''f.''' 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.
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''g.''' The system makes graphic and tabular data vector-scalable in reports.
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''h.''' The system allows for internal hyperlinking to source data in reports.
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''i.''' The system allows users to manually adjust inaccurate data parsing routines for reports.
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''j.''' The system can indicate whether a report is preliminary, amended, corrected, or final while retaining revision history.
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''k.''' The system can automatically generate laboratory reports of findings and other written documents.
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''l.''' The system provides an ad-hoc web reporting interface to report on user-selected criteria.
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''m.''' The system can automatically generate and post periodic static summary reports on an internal web server.
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''n.''' 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.
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''o.''' The system supports PDF/A, an ISO-standardized version of the Portable Document Format (PDF).
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''p.''' The system includes a rules engine to determine the recipients of reports and other documents based on definable parameters.
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''q.''' The system provides printer-friendly audit trails for cleaner reporting of audit data.
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''r.''' The system provides an interface for external clients to search, generate, and view processed data reports based on metadata tags.
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''s.''' The system provides document workflow management tools for streamlining their creation, review, modification, and approval.
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
|}
|}


==1.5 Custom requirements==
The rule updated and reorganized the Section 508 Standards and Section 255 Guidelines ''in response to market trends and innovations in technology.'' The refresh also harmonized these requirements with other guidelines and standards both in the U.S. and abroad, including standards issued by the European Commission, ''and with the World Wide Web Consortium (W3C) Web Content Accessibility Guidelines (WCAG 2.0), a globally recognized voluntary consensus standard for web content and ICT.''</blockquote>
{|
 
| STYLE="vertical-align:top;"|
In discussing ICT, the U.S. Access Board [https://www.access-board.gov/ict/#b-summary-of-key-provisions summarized the key provisions] as such:
{| class="wikitable collapsible" border="1" cellpadding="10" cellspacing="0"
 
|-
<blockquote>The Revised 508 Standards and 255 Guidelines replace the current product-based regulatory approach with an approach based on ICT functions. The revised technical requirements, which are organized along the lines of ICT functionality, provide requirements to ensure that covered hardware, software, electronic content, and support documentation and services are accessible to people with disabilities. In addition, the revised requirements include functional performance criteria, which are outcome-based provisions that apply in two limited instances: when the technical requirements do not address one or more features of ICT or when evaluation of an alternative design or technology is needed under equivalent facilitation.</blockquote>
  ! colspan="3" style="text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px; width:1300px;"| 1.5 '''Custom requirements'''
 
|-
The full (lengthy) information about the ICT Accessibility 508 Standards and 255 Guidelines is found here: [https://www.access-board.gov/ict/ https://www.access-board.gov/ict/]
  ! style="color:brown; background-color:#ffffee; width:470px;"| Request for information
 
  ! style="color:brown; background-color:#ffffee; width:100px;"| Requirement code
The specific software requirements that LabLynx will likely need to consider under Section 508 appear to be found in [https://www.access-board.gov/ict/#chapter-5-software Chapter 5: Software] and [https://www.access-board.gov/ict/#chapter-6-support-documentation-and-services Chapter 6: Support Documentation and Services]. (If for some reason LLX is in the hardware domain, they'll want to also consider[https://www.access-board.gov/ict/#chapter-4-hardware Chapter 4: Hardware] If you're curious about the underlying standards, you can find them in [https://www.access-board.gov/ict/#chapter-7-%C2%A0-referenced-standards Chapter 7: Referenced Standards].
  ! style="color:brown; background-color:#ffffee; width:700px;"| Vendor response
 
|-
Finally, the Section 508 government website has a full Design & Develop section that may be applicable to development process: [https://www.section508.gov/develop/ https://www.section508.gov/develop/]
  | style="padding:15px; width:470px;" |'''a.'''
 
  | style="background-color:white; padding:15px;" |                                                                                                                                                   
==Additional information==
  | style="background-color:white;" |
 
|-
1. The Section 508 website and its glossary mention LIMS under "[https://www.section508.gov/art/glossary/#S scientific instrument]," though only secondarily. At the end: "If a scientific instrument is integrated with a computer or a monitor, the computer (and associated operating system) and the monitor would be separate EIT deliverables, requiring their own Government Product Accessibility Templates (GPAT). If the computer included application software, this software would be another EIT deliverable requiring its own GPAT."
  | style="padding:15px; width:470px;" |'''b.'''
   
  | style="background-color:white; padding:15px;" |                                                                                                                                                         
2. It appears some software can qualify for "a legally-defined Exception (Back Office)," as found in this example with STARLIMS and the VA: [https://www.oit.va.gov/Services/TRM/ToolPage.aspx?tid=7502 https://www.oit.va.gov/Services/TRM/ToolPage.aspx?tid=7502]
  | style="background-color:white;" |
 
|-
3. Some additional posts and guides that may be revealing:
  | style="padding:15px; width:470px;" |'''c.'''
* [https://www.levelaccess.com/how-do-i-determine-if-my-web-site-or-application-is-section-508-compliant/ How do I determine if my website or application is Section 508 compliant?]
  | style="background-color:white; padding:15px;" |
* [https://ftp.cdc.gov/pub/Software/RegistryPlus/508%20Compliance/508softwareandos.doc GSA Guide For Making Software Applications and Operating Systems Accessible] (.doc file; NOTE: No date, so not sure if incorporates amended material, so be careful)
  | style="background-color:white;" |
* [https://www.dhs.gov/publication/dhs-section-508-compliance-test-processes DHS Section 508 Compliance Test Processes]
|-
  | style="padding:15px; width:470px;" |'''d.'''
  | style="background-color:white; padding:15px;" |
  | style="background-color:white;" |
|-
  | style="padding:15px; width:470px;" |'''e.'''
  | style="background-color:white; padding:15px;" |
  | style="background-color:white;" |
|-
  | style="padding:15px; width:470px;" |'''f.'''
  | style="background-color:white; padding:15px;" |
  | style="background-color:white;" |
|-
  | style="padding:15px; width:470px;" |'''g.'''
  | style="background-color:white; padding:15px;" |
  | style="background-color:white;" |
  |-
  | style="padding:15px; width:470px;" |'''h.'''
  | style="background-color:white; padding:15px;" |
  | style="background-color:white;" |
|-
  | style="padding:15px; width:470px;" |'''i.'''
  | style="background-color:white; padding:15px;" |
  | style="background-color:white;" |
|-
  | style="padding:15px; width:470px;" |'''h.'''
  | style="background-color:white; padding:15px;" |
  | style="background-color:white;" |
|-
  | style="padding:15px; width:470px;" |'''i.'''
  | style="background-color:white; padding:15px;" |
  | style="background-color:white;" |
|-
  | style="padding:15px; width:470px;" |'''j.'''
  | style="background-color:white; padding:15px;" |
  | style="background-color:white;" |
|-
|}
|}

Latest revision as of 21:23, 28 February 2022

The laws themselves

1. Federal Telecommunications Act of 1996, Section 255 (47 U.S.C. § 255 - Access by persons with disabilities)

(b) Manufacturing

A manufacturer of telecommunications equipment or customer premises equipment shall ensure that the equipment is designed, developed, and fabricated to be accessible to and usable by individuals with disabilities, if readily achievable.

(c) Telecommunications services

A provider of telecommunications service shall ensure that the service is accessible to and usable by individuals with disabilities, if readily achievable.

(d) Compatibility

Whenever the requirements of subsections (b) and (c) are not readily achievable, such a manufacturer or provider shall ensure that the equipment or service is compatible with existing peripheral devices or specialized customer premises equipment commonly used by individuals with disabilities to achieve access, if readily achievable.

The term disability is defined here. You can read the full entry, but the basics are:

(1) Disability The term “disability” means, with respect to an individual—

(A) a physical or mental impairment that substantially limits one or more major life activities of such individual;
(B) a record of such an impairment; or
(C) being regarded as having such an impairment (as described in paragraph (3)).

The term readily achievable is defined here. It is defines as:

(9) Readily achievable The term “readily achievable” means easily accomplishable and able to be carried out without much difficulty or expense. In determining whether an action is readily achievable, factors to be considered include—

(A) the nature and cost of the action needed under this chapter;
(B) the overall financial resources of the facility or facilities involved in the action; the number of persons employed at such facility; the effect on expenses and resources, or the impact otherwise of such action upon the operation of the facility;
(C) the overall financial resources of the covered entity; the overall size of the business of a covered entity with respect to the number of its employees; the number, type, and location of its facilities; and
(D) the type of operation or operations of the covered entity, including the composition, structure, and functions of the workforce of such entity; the geographic separateness, administrative or fiscal relationship of the facility or facilities in question to the covered entity.

2. Rehabilitation Act of 1973, Section 508, amended (29 U.S.C. 794d - Electronic and information technology)

There's a government website dedicated to Section 508: https://www.section508.gov/ The related laws and polices can be found here. The intro states (italics emphasis mine):

In 1998, Congress amended the Rehabilitation Act of 1973 to require Federal agencies to make their electronic and information technology (EIT) accessible to people with disabilities. The law (29 U.S.C § 794 (d)) applies to all Federal agencies when they develop, procure, maintain, or use electronic and information technology. Under Section 508, agencies must give disabled employees and members of the public access to information comparable to the access available to others.

The U.S. Access Board is responsible for developing Information and Communication Technology (ICT) accessibility standards to incorporate into regulations that govern Federal procurement practices. On January 18, 2017, the Access Board issued a final rule that updated accessibility requirements covered by Section 508, and refreshed guidelines for telecommunications equipment subject to Section 255 of the Communications Act. The final rule went into effect on January 18, 2018.

The rule updated and reorganized the Section 508 Standards and Section 255 Guidelines in response to market trends and innovations in technology. The refresh also harmonized these requirements with other guidelines and standards both in the U.S. and abroad, including standards issued by the European Commission, and with the World Wide Web Consortium (W3C) Web Content Accessibility Guidelines (WCAG 2.0), a globally recognized voluntary consensus standard for web content and ICT.

In discussing ICT, the U.S. Access Board summarized the key provisions as such:

The Revised 508 Standards and 255 Guidelines replace the current product-based regulatory approach with an approach based on ICT functions. The revised technical requirements, which are organized along the lines of ICT functionality, provide requirements to ensure that covered hardware, software, electronic content, and support documentation and services are accessible to people with disabilities. In addition, the revised requirements include functional performance criteria, which are outcome-based provisions that apply in two limited instances: when the technical requirements do not address one or more features of ICT or when evaluation of an alternative design or technology is needed under equivalent facilitation.

The full (lengthy) information about the ICT Accessibility 508 Standards and 255 Guidelines is found here: https://www.access-board.gov/ict/

The specific software requirements that LabLynx will likely need to consider under Section 508 appear to be found in Chapter 5: Software and Chapter 6: Support Documentation and Services. (If for some reason LLX is in the hardware domain, they'll want to also considerChapter 4: Hardware If you're curious about the underlying standards, you can find them in Chapter 7: Referenced Standards.

Finally, the Section 508 government website has a full Design & Develop section that may be applicable to development process: https://www.section508.gov/develop/

Additional information

1. The Section 508 website and its glossary mention LIMS under "scientific instrument," though only secondarily. At the end: "If a scientific instrument is integrated with a computer or a monitor, the computer (and associated operating system) and the monitor would be separate EIT deliverables, requiring their own Government Product Accessibility Templates (GPAT). If the computer included application software, this software would be another EIT deliverable requiring its own GPAT."

2. It appears some software can qualify for "a legally-defined Exception (Back Office)," as found in this example with STARLIMS and the VA: https://www.oit.va.gov/Services/TRM/ToolPage.aspx?tid=7502

3. Some additional posts and guides that may be revealing: