Data Entry Mechanisms

> Manually enter data in Customizable Document Object Forms
> Import legacy data from existing Data sources such as DOORS or Requisite Pro
> Extract data from existing Word Documents and Excel files
> Generate content using the integrated Regulatory Wizards
> Reuse existing Aligned Elements data by copying from other projects
> Download and import examples and best-practice Items from Aligned Web site

 

Data Handling - Ease Of Use

> Fully customizable Document Object Design
> Use your own naming conventions on Objects, Types and Fields
> Chapter Structure - Hierarchical Organization of Objects in flexible structure
> Rich Text Support including images, symbols, tables and hyperlinks
> Integrated Spell-Checker with custom Dictionaries to create Glossary
> Add File Attachments to Objects
> Insert OLE content (e.g. Visio diagrams) in Text
> Insert File Links in text
> Insert URL's in text
> Make Copies of Objects including traces
> Generate Object of different Object Type - automatically sets trace between the source and target Object
> Automatic Filtering of Objects containing particular attribute values
> Set up Workflows for process control
> Consistency Coverage Summary for controlling current state
> Design Control Category Filter for hiding context irrelevant types
> Keyboard shortcuts for repeatable tasks
> Breakdown charts with drill-down capabilities
> Full-text search
> Copy-to-clipboard support
> Generate on-the-fly reports to Word and Excel
> Batch editing of multiple Document Objects
> Bookmark Document Objects Favourites
> Subscribe to email notification of modifications of Document Objects Favourites
> Open Objects from Element hyperlinks
> Create Element hyperlinks in emails and word documents with Drag-and-drop
> Use Tags to group and Categorize Document Object sets

 

Document Object Design - Supported Field Types

> Text
> Rich Text
> Integer
> Double
> Integer Range
> DateTime
> Enumeration
> User Enumeration
> Table
> Rich Text Table
> File
> Multiselect

 

Object Types in Standard Setup

> Requirement
> Specification
> Use Case
> Test Case
> Executed Test Case
> Failure Mode
> Hazard
> Mitigation
> Review
> File
> Issue
> Attachments
> Change Request

 

Tracing

> Trace Explorer - using tree-structure to depict full Trace Landscape
> Easy Drag and Drop Trace-setting mechanism
> Set Traces From or To Objects
> Drag and Drop single/multiple Objects onto single/multiple Target Objects
> Intelligent Search for probable Trace Candidates
> Automatic detection of missing Traces
> Suspect Trace State on children if parent object is modified
> Automatic detection of suspect Traces
> Tracing to objects in other Projects
> Trace to parts of chapter structure
> Export traces to Excel or Clipboard
> Integrated Trace Table Designer and Analyser
> Set traces to or from individual test case steps or use case rows

 

Revision-Based Change Control

> Change Comment compulsory at every Object modification
> Change Log includes What/Who/When/Why
> Complete Chronological Audit Trail - search, sort, filter
> Revert object to state of previous revision
> Customizable Standard Change Comments
> Suggestion of recently used change comments
> Side by Side comparison of any two revisions
> Revision History for each object
> Possible to Disable (but not Delete) Objects
> Possible to Enable previously Disabled Objects

 

Workflow Support

> State-machine driven, customisable workflows
> User restrictions of selected state changes
> Email notifications on state changes to Users or User Groups
> Inconsistency controls permitting/preventing state change
> Email notifications to assignee on task assignments
> Push files to external Document Management Systems on state changes
> Automatically update attribute data on state changes
> Invalidate state on attribute change
> Calculation of attribute value based on other attribute values
> Lock objects to prevent updates after release
> Start external Processes / Programs processing Aligned Elements data

 

Inconsistency Analysis

Checks for...
> Missing and Obsolete Outgoing Traces
> Missing Incoming Traces
> Illegal Traces
> Suspect Traces
> Invalid Trace Counts
> Document that have not been signed
> Insufficiently mitigated Risks
> Unmitigated Risks
> ALAP Risks
> Open Issues/Deviations
> Incomplete E-Signatures
> Objects with particular attribute data e.g. Failed Test cases
> Objects that are not part of Word Document
> Objects that have not been Reviewed
> Word Documents containing outdated Objects
> Objects have been modified after Review
> Object with open issues
> Table Attributes with outdated trace references in designated columns
> Objects with unexpected attribute values or value combinations
> Autocompare of IEC 62304 Software Safety Classification and referenced risks
> Test Case has been updated after last execution
> Auto-create Issues directly from Inconsistencies
> Combining inconsistencies using an OR rule
> Evaluate inconsistencies based on the Object state
> Evaluate inconsistencies based on state of traced Objects
> Inconsistency checks at Save to prevent saving inconsistent Objects
> Workflow state change inconsistency checks

 

Object Queries

Available filters...
> Matching Attributes
> Has/Has not Trace to specific type
> Has/Has not Trace from specific type
> Has/Has not Trace to Object in other Query
> Has/Has not Trace from Object in other Query
> Revision Number
> Revision Author
> Revision Date
> Revision Comment
> Risk RPN/NRPN before/after applying mitigations
> Risk Threshold before/after applying mitigation
> C# function evaluating attributes
> Has inconsistency of particular type
Available output processing...
> Sort and search matches
> Display attribute set
> Display match distribution in chart
> Export output set to Word, Excel or Clipboard
> Drag and Drop for traceability
> Use output set in Word Integration
> Set Snapshot
> Analyze for inconsistencies
> Drill down deeper using breakdown charts

 

Integrated Risk Management according to ISO 14971

> Integrated FMEA and Preliminary Hazard Analysis
> Includes parameters such as Causes, Effects, Severity, Probability and Visibility
> Customizable range for Severity, Probability and Visibility
> Automatic permutation of all Causes and Effects in a Failure Mode
> Automatic calculation of Risk Probability Number
> Automatic calculation of New Risk Probability Number after adding mitigations
> Sharing Mitigations between several Failure Modes
> Customizable formula for calculating Risk Probability Number
> Divide Risks in Acceptable, Inacceptables and ALARPs
> Customizable Risk and ALARP Threshold levels
> Risk Summary output, before and after mitigations
> Automatic listing of detected non-mitigates risks
> Automatic listing of detected non-mitigated high severities
> Full traceability to Failure Modes and from Mitigations
> Support of concurrent Probability of Occurrence and Probability of Harm
> Automatic sorting of Mitigations according to Risk Reduction type (Design, Protection, Information etc)
> Relative or Absolute Mitigation reduction calculation

 

Design Review Support

> Centralized Design Reviews
> Decide which Objects to Review
> Automatic Invitation of Participants per E-Mail
> Assign Roles to Participants
> Collect all deviations in Review
> Automatic assignment of deviations to the corresponding Objects to correct
> Automatic Snapshot on Objects under Review at Start and End of Review
> Automatic generation of Review Protocol in Word
> Filter out the Objects that have not been Reviewed
> Filter out the Objects that have been Reviewed
> Filter out the Objects that have been modified after Review

 

FDA 21 CFR Part 11 Compliant User Management

> User Groups
> User Rights
> Encrypted Passwords
> Import/Export of Users and User Groups between Projects
> Automatic notification to Administrator at suggested break-in attempts
> Use Windows password as alternative login method
> Easy change of User data in multiple projects
> Send Email to currently logged-in users
> Management of electronic certificates
> Email notification on User association with new Project

 

Base-lining / Snapshots

> Snapshot on any set of Objects and Chapters
> Snapshot includes traceability view of target Objects
> Snapshot includes traceability view of included Objects
> Snapshot all objects that are part of a Word Document
> Side by Side comparison of two Snapshot
> Side by Side comparison of Snapshot and Current Object State

 

Word Integration

> Freely mix regular Word content and Aligned Elements content in any order
> Customizable Word Layout/look-and-feel for all object types - support multiple look-and-feel sets
> Insertion of arbitrary set of Objects and Chapters from one or more Projects
> Insertion of content of Base Lines
> Insertion of of Objects Result from Queries - as objects with or w/o chapters or lists
> Insertion of Review Protocols
> Insertion of Risk/FMEA/PHA Tables
> Insertion of DHF Index
> Insertion of Risk Summary
> Database Synchronization - DB updated with modifications made in Word document
> Document Synchronization - Word Document is updated with modifications made in DB
> Synchronization of selected Objects
> Synchronization of chapter names and chapter content
> Synchronization - automatic sync without opening Word
> Two-click creation of File objects with populated Word Documents
> Map Chapter level to any Word Heading level
> Automatic Revision History with automatic change comments
> Insertion of Customizable Trace Tables
> Use upward Trace Tables
> Use downward Trace Tables
> Use Multi column Trace Tables
> Use Mixed Trace Tables (Trace Tables with additional Attribute content)
> Semi Automatic Extraction and Insertion of data from Word Document into database
> Automatic Detection of which objects which have not been inserted in Word Documents
> Automatic Detection of which objects are outdated in the Word Documents
> Integrated E-Signing of PDF copies of Word Document with or without the application of X.509 E-Certificates for Document Release

 

Import / Export

> Customizable XSLT driven export for e.g. XML, CSV, Excel and HTML
> Import Objects via XML
> Recreate traces on import
> Recreate chapter structure on import
> Customizable import change comment
> Synchronized import (overwrite existing data with imported data)
> Automatic suggestion of Object to overwrite at synch import
> Auto-Suggestions for mapping of unknown type
> Auto-Suggestions for mapping of unknown fields
> Auto-Suggestions for mapping of unknown field values
> Auto-Disable Objects after export
> Copy Objects between projects
> Export of revision history
> Export of previous revisions
> Apply XSLT transformations at import

 

System Features

> Client-Server System with Central Repository
> Platform independent Web Access to Web Client
> SSL-by-default secure communication with Web Client
> Simultaneous Multi-Client access
> Integrated DHF Index support
> Integration with GitHub Tickets
> Integration with Atlassian Jira
> Integration with Trac
> Integration with Countersoft Gemini
> Integration with Team Foundation Server (TFS)
> Integration with external Document Management Systems e.g. Share Point
> Possible to link projects to provide tracing between product modules
> Take Project Offline / Online
> Use Test Runs to plan and manage Verification and Validation activities
> Copy and rename entire project / parts of project to other Server

 

Deployment Options

Client Deployment Options
> Standard Windows Installer
> Special Windows Installer for Word x64 support
> Web Client compatible with all modern brousers
> Demo Installer
Server Multi-Site Deployment Options
> Deployment on Citrix
> Hosting in Microsoft Azure Cloud Environment

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