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.
Validation Planning and 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 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.
Validation Dashboard
Global and personal dashboards deliver actionable validation intelligence regarding validation risks, incidents, requirements coverage, testing status and much more.
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.
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.
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.
Lean Validation Project Management
Optimize validation processes to drive project organization, efficiency, task management, cost management and collaboration across the project.
Custom Validation Project Attributes
Establish custom attributes for validation assets including requirements, test cases, incidents, et al describing unique, company-specific, searchable project attributes.
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 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.
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.
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 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 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 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.
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.
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.
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™.
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.
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.
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.
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.
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.
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.
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
Requirements Coverage Status
From the dynamic dashboard, trace requirements coverage to test scripts to ensure full coverage of all requirements with test scripts.
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.
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.
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.
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.
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.
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.
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.