tel: +41 44 312 50 20 mail: info@aligned.ch

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Features

Data Entry Mechanisms
> Manually enter data in Customizable Document Object Forms
> Import legacy data from existing Data sources
> Extract data from existing Word Documents
> Generate content using the 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 Object Design
> Use your own naming conventions on Objects
> Chapter Structure in Project View - Hierarchical Organization of Objects in flexible structure
> Rich Text Support
> Integrated Spell-Checker
> 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
> 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


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


Tracing
> Trace View - using tree-structure to depict full Trace Landscape
> Easy Drag and Drop Trace mechanism
> Set Traces From or To Objects
> Drag and Drop multiple Objects onto multiple Target Objects
> Intelligent Searching for probable Trace Candidates
> Automatic detection of missing Traces
> Suspect Trace State if child object is modified
> Automatic detection of suspect Traces
> Tracing to objects in other Projects
> Trace to parts of chapter structure


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


Inconsistency Analysis
Checks for...
> Missing Traces
> Suspect Traces
> Unmitigated Risks
> Open Issues/Deviations
> Incomplete E-Signatures
> Objects with particular attribute data
> 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 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
> C# function evaluating attributes
Available output processing...
> Sort matches
> Display attribute set
> Print output report
> Export output set
> Drag and Drop for traceability
> Use output set in Word
> Set Snapshot
> Analyse for inconsistencies


Integrated Risk Management
> FMEA based approach
> Includes 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
> Customizable Risk Threshold
> Automatic compilation of non-mitigates risks
> Automatic compilation of non-mitigated high severities
> Full traceability to Failure Modes and from Mitigations


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


Baselining / 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
> 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
> Customizable Word Layout for all object types
> 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 or lists
> Insertion of Review Protocols
> Insertion of Risk/FMEA Tables
> Insertion of DHF Index
> 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-Singing of PDF copies of Word Document with x.509 E-Certificates for Release


Import / Export
> Customizable XSLT driven export for 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


System Features
> Client-Server System with Central Repository
> Simultaneous Multi-Client access
> Take Project Offline / Online
> Copy entire project to other Server
> Integration with Jira
> Integration with Trac
> Possible to link projects to provide tracing between product modules


Deployment Options
Client Deployment Options
> Standard Offline Installer
> Web deployment (Click Once) including automatic version updates
Server Multi-Site Deployment Options
> Deployment on Citrix
> Prepared For Database Replication

"Working with Aligned proved to be the correct choice and within a short timeframe Aligned has provided us with a consistent and up-to-date copy of the DHF."

Uwe Kolb, Quality Engineer

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