Full feature list
What you get from Aligned Elements
Data Entry Mechanisms |
| > Manually enter data in Customizable Document Object Forms |
| > Import legacy data from existing Data sources such as DOORS, Polarion 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 |
| > Add File Attachments to Objects |
| > Display Document Objects side-by-side |
| > 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 |
| > Dynamic List |
| > Text-To-Number |
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 on state changes |
| > Start external Processes / Programs processing Aligned Elements data on state changes |
| > Generate Document Objects on state changes |
Inconsistency Analysis |
| Checks for... |
| > Missing and Obsolete Outgoing Traces |
| > Missing Incoming Traces |
| > Illegal Traces |
| > Suspect Traces |
| > Invalid Trace Counts |
| > Document that has 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 incoming and outgoing traces |
| > Check for Test Cases not being executed in Test Runs |
| > Evaluate the Uniqueness of an attribute value within the project |
| > Check for illegal incoming traces |
| > Check for incoming suspect traces |
| > Inconsistency checks at Save to warn or 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 |
| > Use Text or Numbers to define probability/severity levels |
| > Customizable Risk Result presentation (text, number, color) |
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 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 |
| > Use attribute values as import synchronization map keys |
| > Apply XSLT transformations at import |
| > Trigger automatic import of Automated Test Results from Continuous Integration servers (TeamCity etc.) |
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 Azure DevOps (former 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 |
| > Branch and Merge Projects for parallel development |
| > Pre-populate Project with default data at creation |
| > Automate Aligned Elements tasks from Continuous Integration servers |
Deployment Options |
| Client Deployment Options |
| > Standard Windows Installer |
| > Special Windows Installer for Word x64 support |
| > Web Client compatible with all modern browsers |
| > Demo Installer |
| Server Multi-Site Deployment Options |
| > Deployment on Citrix |
| > Hosting in Microsoft Azure Cloud Environment |
