ValidationMaster™ Product Features

 

ValidationMaster™ is a comprehensive Enterprise Validation Lifecycle Management and Quality system designed exclusively for lean validation processes.    The system provides a single source of truth for all validation projects. 

ValidationMaster™ includes advanced project management features that allows you to create validation projects for computer systems validation, equipment validation, process validation, facility validation, cold chain validation, and other types of validation projects.  A core feature set as highlighted below is TestMaster™ - a comprehensive automated test engine that supports fully automated testing as well as "hands on" validation testing.

A core feature of ValidationMaster™ is the ValidationMaster Portal - a full featured SharePoint-based content management system that delivers validation content management, electronic workflows and approvals.  The system is designed in compliance with 21 CFR Part 11 Electronic Records; Electronic Signature Final Rule and ISPE GAMP 5® Risk-based Approach For Computer Systems Validation.

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Validation Planning  & General Features

 

Validation Kanban Board

In support of our lean validation methodology, ValidationMaster™ includes a validation kanban board to track all validation activities and project deliverables.

Validation Dashboard

Global and personal dashboards deliver actionable validation intelligence regarding validation risks, incidents, requirements coverage, testing status and much more.

Validation Inventory Management

As a single source of truth for validation, you can manage ALL types of validation projects including computer systems, equipment, process, cold chain, et al from an easy-to-use interface. 

Validation Task Management

Manage all validation tasks and track time/resources and costs using ValidationMaster™.  System includes the ability to track tasks associated with key deliverables and requirements.

Mobile Support 

ValidationMaster™ is the FIRST lean validation management system to support mobile devices - the application is accessible through any Windows, Apple or Android device. 

Unlimited Number of Projects

ValidationMaster™ is a SINGLE SOURCE OF TRUTH for all of your validation projects.  You can manage all validation projects from a single integrated application.

 

 

Track Periodic Review

Track and manage initial validation, last validation and periodic review dates and show next periodic validation review date.  Generate periodic review reports showing entire validation inventory.

Custom Validation Project Attributes

Establish custom attributes for validation assets including requirements, test cases, incidents, et al describing unique, company-specific, searchable project attributes .

Configurable Validation Project Groups

Organize your validation projects into project groups to faciliate search/retrieval as well as reporting and allow you to effectively manage lean validation projects across the company. 

Lean Validation Project Management

Optimize validation processes to drive project organization, efficiency, task management, cost management and collaboration across the project.

Add Attachments For Tests/ Requirements /Incidents

Avoid lost validation deliverables through the ability to add attachments and supporting documentation for enhanced validation due diligence. 

Configurable Web-Based System

ValidationMaster™ is a configurable web-based system designed to manage the full lifecycle of all types of enterprise validation projects.

RequirementsMaster™ Features

 

Easy Requirements Entry

ValidationMaster™ is used for all user/functional/design requirements and allows you to manually enter them or accelerate entry using specially designed Excel® spreadsheets.   

Requirements Audit Trail

View all changes to requirements through a comprehensive audit trail which tracks who changed each requirement, the requirement version, as well as time/date stamp.

Requirements Coverage Dashboard

Track and manage all requirements and ensure they all have test coverage through our comprehensive requirements coverage dashboard showing graphically your full requirements coverage. 

Color-Coded Requirements Risks

All requirements are color-coded with configurable risk categories to allow users to see test coverage and associated risks ranking with each defined requirement.

Requirements Linking

Requirements can be linked to test cases, incidents and software releases for easy traceability and management. Linking requirements will ensure easy publishing of trace matrices.

Requirements Reporting

A key validation deliverable is the User Requirements Specification (URS) as well as Functional Requirements and Design Requirements.  Easily generate user-definable requirements reports through ValidationMaster™.

TestMaster™ Automated Testing Features

 

Automated Test Capture & Online Execution

Through our "hands on" testing capability, automatically capture objective test evidence and execute validation test scripts online. 

Reusable Test Script Library

After initial validation testing, regression testing is inevitable.  Establish and develop a reusable test script library to facilite regression testing through ValidationMaster™.

Fully Automated Test Scheduling & Execution

Fully automated test scripts that can be executed without human intervention is possible through ValidationMaster™.  Schedule tests for online automated testing/execution.  

Automated Test Script Publishing

Once test scripts are captured and executed online, generate compliant executed test script documentation and publish in Microsoft Word® document formats for review and approval.  

Capture Pass/Fail Results

During test script execution, ValidationMaster™ captures and records pass/fail results.  If the test is passed with some exceptions, the system allows recording with documented exceptions.  

Real-Time Test Execution Status

During test script execution, ValidationMaster™ records results in real-time.  This is viewable through integrated dashboards.  Test scripts may also be paused/resumed if required.

ReportMaster™ Features

 

Graphical Reports

ValidationMaster™ allows you to configure/execute graphical web-based reports to highlight key validation tasks, releases, and deliverables within the system.  Reports may be viewed online or through mobile devices.

Custom Report Output

If you have established validation processes, your SOPs dictate the format of your reports.  ValidationMaster allows you to configure your unique reports within the system to ensure compliance.  

Supports Multiple Format

ValidationMaster allows you to publish documents in multiple formats depending on the document type and formatting requirements.  We support Word, Excel, PDF and other formats.

Publish Directly To ValidationMaster™ Portal

Upon completion of test script execution, ValidationMaster allows you to publish test scripts directly to the ValidationMaster portal for review and approval. 

Record Once, Use Many

ValidationMaster allows you to record a test script once and use it for multiple documents.  For example, a single test script can be used as an OQ, Work Instruction or training manual.  

Electronically Route/Approve Reports

ValidationMaster is integrated with DocuSign and supports the electronic route, review and approval of validation deliverables in serial or parallel reviews.  

ValidationMaster Portal™ Features

 

Quality & Risk Management

ValidationMaster™ offers a comprehensive Part 11-compliant quality and risk management portal that includes quality features such as CAPA, audit mgt, N/C, change control and regulated ECM.

Validation Calendar, KPIs & Dashboards

The system includes a rolling schedule for validation projects highlighting their status and periodic review dates.  The system tracks validation KPIs and includes quality dashboards.

Graphical Content Workflows

Powered by Nintex®, the portal includes graphical workflows to support document and change control, CAPA, N/C, and other workflow processes.

Audit Management

The system includes a comprehensive audit management system in compliance with ISO 9001.  You can setup pre-defined audit questions to build your own audit checklists and reports.

Training & Competency Management

Training is essential for validation.  ValidationMaster allows you to capture and manage training records to support your validation due diligence for global regulators.  

Controlled Document/Content Management

The ValidationMaster portal supports controlled/uncontrolled documents and enforces document templates and processes to ensure sustained compliance.

IncidentMaster™ Features

 

Automated Incident Reporting

During validation testing, easily raise an incident if you encounter a bug/anomaly and link the report directly to your test scripts to ensure compliance.  Never lose an incident report again!

Full Lifecycle Incident Management

Fully track and manage incident tasks and their related associations with test cases, requirements, and other processes.  Incidents can be routed to key stakeholders for task management.

Real-time Incident Monitoring

The ability to monitor and manage incidents in real-time and their associated tasks, test cases and other processes. Incident may spawn corrective actions or N/C's. 

Convert Incident to Requirement

In the case where an incident is discovered to be an actual requirement, incident can be easily converted to requirements and linked to test scripts for closed loop processing.

Incident Workflows

Incidents can be routed for review and approval through automated workflows.  Validation due diligence is created through our audit trails that tracks incident workflows to their end.

Incident Quality Management

ValidationMaster™ supports comprehensive quality management processes for the effective management of incidents throughout the system.  All incidents are given unique numbers and are tracked from inception to close.

TraceMaster™ Features

 

Forward/Reverse Traceability

TraceMaster has the ability to generate forward and reverse trace matrices which trace requirements to test scripts and test scripts to requirements.

Configurable Trace Matrix

Most organizations have SOPs that provide governance for their documentation.  TraceMaster allows you to publish your trace matrices in your unique document formats.  

Requirements Coverage Status

From the dynamic dashboard, trace requirements coverage to test scripts to ensure full coverage of all requirements with test scripts.

Trace Project to Software Release

TraceMaster™ allows authorized users to trace a specific project to a specific software release. In doing so, you can search for all validation deliverables based on a specific software release.

Trace Source Code to Design Requirements

TraceMaster™ facilitates the tracing of custom source code to design requirements.  This bi-directional tracing helps ensure compliance and software quality

Trace Incidents to Test Scripts/Tasks

All incident can be traced to test scripts and tasks to support lean validation processes.  Incident reports can be easily generated to show the status of incident reports and the testing and tasks associated with them.

Integrations and Language Support

 

Internationalized Language Support

Supports 12 common languages out of the box with over 160+ languages that can be configured if required.  Language packs can be added at your request.

Source Code Mgt Integrations

ValidationMaster™ includes its own source code management system.  You can link artifacts in the system to specific source code revisions for end-to-end traceability from requirements to code.

Bug Management Integrations

ValidationMaster supports integrations including Jira, Bugzilla, IBM Rational ClearQuest, Redmine, Microsoft Team Foundation Server (TFS), and FogBugz.

Requirements Mgt Integrations

ValidationMaster includes its own requirements management engine.  However, we support popular engines including IBM Rational DOORS® , Jama Contour, and Version One.

Automation Test Engine Integrations

Automated testing is one of the cornerstones of lean validation.  ValidationMaster can integrate with Selenium,  HP Unified Functional Testing (UFT) and others.

Load & Performance Testing Integrations

Load and performance testing can help facilitate Performance Qualification (PQ).  ValidationMaster supports Neoload and Loadrunner as well as others for PQ testing.