Frequently Asked Questions

ValidationMaster^® is The Enterprise Digital Validation Platform^™, developed by OnShore Technology Group. It brings validation planning, requirements and risk management, testing, traceability, reporting, and quality management together in one integrated enterprise platform for regulated life sciences organizations.

The platform includes ValidationMaster Studio^™, ValidationMaster Portal^®, ValidationMaster eQMS^™, ValidationMaster VERITAS^™, CloudMaster 365^™ Enterprise Validation Accelerators^™, Reporting & Analytics, and Open APIs. TestMaster AI^™ (COMING SOON, Early Access Available) will join them as the AI-powered intelligence engine of the platform.

ValidationMaster^® is built for pharmaceutical, biotechnology, medical device, and other regulated life sciences organizations. It serves QA Directors, CIOs, VPs of Quality, validation leaders, and digital transformation leaders who need consistent governance, traceability, and executive visibility across their validation programs, from a single site to global operations.

Yes. You can deploy the capabilities you need today and add more as your validation program grows. Every capability runs within the same ValidationMaster^® platform architecture, so you expand without creating disconnected tools or fragmented processes.

Yes, ValidationMaster includes over 40+ integrations out-of-the-box including popular tools such as Microsoft Azure DevOps, Microsoft SharePoint, RanoreX, Neoload, LoadRunner, Jira, JUnit, Microsoft Teams, and many others. ValidationMaster’s open API facilitates integration with many other enterprise technologies. Contact us for more information.

No. ValidationMaster^® adapts to your validation methodology rather than forcing rigid workflows. It combines flexibility with structured governance, so your teams keep the approach defined in your SOPs while gaining one consistent, traceable framework across systems and sites.

Yes. ValidationMaster^® supports validation of SaaS, PaaS, hybrid infrastructure, and modern enterprise applications. CloudMaster 365^™ Enterprise Validation Accelerators^™ provide pre-developed requirements, test scripts, and templates for ERP, QMS, LIMS, MES, CRM, and other enterprise platforms, so validation keeps pace with continuous cloud releases.

The platform itself can be deployed as SaaS, in a customer-controlled cloud, as a hybrid environment, or across multiple regions.

Yes. ValidationMaster^® was built for organizations managing complex validation requirements across multiple systems, teams, sites, and regulatory environments. One platform gives leadership consistent governance, portfolio-wide visibility, and an enterprise architecture that scales as the validation program grows, including multi-region deployments and multi-language support.

Unlike traditional validation software solutions that rely on disconnected tools and fragmented workflows, ValidationMaster^® is a comprehensive Enterprise Digital Validation Platform designed to unify and streamline the entire validation lifecycle. From planning and execution to quality management, mobile field operations, reporting, and regulatory oversight, ValidationMaster brings everything together within a single, integrated platform—providing centralized data, standardized workflows, enterprise-wide visibility, and complete audit traceability.

Built on more than 40+ years of life sciences validation expertise and experience supporting over 300+ enterprise validation programs, ValidationMaster combines proven industry knowledge with powerful digital innovation. With more than 40 enterprise integrations out-of-the-box, the platform connects seamlessly with existing business systems to improve efficiency, strengthen compliance, and accelerate digital transformation.

ValidationMaster is the only enterprise digital validation platform available in multiple languages suitable for global enterprise platform deployment.

Taking innovation even further, TestMaster AI^™ (coming soon, with Early Access available) introduces AI Digital Workforce Assistants^™ designed to enhance validation productivity while preserving critical human oversight through our guiding principle: Human-Guided. AI-Assisted. Validation Professional-Approved.

The difference? One powerful platform. One connected validation ecosystem. Complete lifecycle control.

ValidationMaster^® is a comprehensive Enterprise Digital Validation Platform designed to validate ANY enterprise, desktop, mobile, or bespoke application—as well as virtually any equipment, laboratory, cold chain, or other regulated validation process.

From ERP, eQMS, EDMS, MRP, MES, LIMS, CRM, and other enterprise applications to equipment qualification, facilities, utilities, cleaning, process, and laboratory validation, ValidationMaster provides a single, unified platform for managing the entire validation lifecycle.

With ValidationMaster VERITAS^™, organizations can also execute validation and qualification activities directly in the field, including Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), User Acceptance Test (UAT), Factory Acceptance Testing (FAT), Site Acceptance Testing (SAT), and commissioning protocols.

One Platform. Every System. Every Validation Process.

TestMaster AI™ is the AI-powered intelligence engine of the ValidationMaster® platform. A coordinated team of AI Digital Workforce Assistants™ supports every phase of the validation lifecycle, while qualified validation professionals review and approve every output. Human-Guided. AI-Assisted. Validation Professional-Approved.

TestMaster AI™ is COMING SOON, and Early Access is available. Join the Early Access program.

CloudMaster 365™ accelerators are pre-developed validation assets, including requirements, protocols, and templates, for ERP, eQMS, MES, LIMS, and other enterprise platforms. They give your team a CSA-aligned starting point, so implementations and upgrades take less time, effort, and cost. Explore CloudMaster 365™.

Yes. VERITAS™ lets you execute protocols without connectivity. Completed work is held in local secure storage and synchronizes automatically with the ValidationMaster® platform when connectivity returns. It runs on Apple iPhone® and iPad®, Android™ phones and tablets, and Windows tablets. Explore VERITAS™.

ValidationMaster eQMS™ manages quality processes such as document control, change requests, CAPA, nonconformance, and audits. ValidationMaster IQ™, built on Microsoft 365 and powered by Zensai, manages training and competency. IQ™ is fully integrated with eQMS™, so training connects to the quality processes it supports. Explore eQMS™ or explore IQ™.

ValidationMaster^® keeps validation records, traceability, evidence, approvals, and audit trails in one governed system. Teams can generate inspection-ready reports and forward and reverse traceability matrices from the data they already capture, and executive dashboards show readiness across the portfolio in real time.

ValidationMaster^® provides structured validation workflows, end-to-end traceability, complete audit trails, role-based access, and electronic signatures. The platform is designed to support 21 CFR Part 11, EU Annex 11, GAMP^® 5 Second Edition, FDA Computer Software Assurance (CSA), and ALCOA+ data integrity principles.

ValidationMaster eQMS^™ is designed to support organizations operating under ISO 9001 Quality Management Systems and FDA Quality System Regulation (21 CFR Part 820).

Yes. ValidationMaster® supports risk-based approaches aligned with FDA Computer Software Assurance, along with ISPE GAMP® 5 Second Edition guidance, 21 CFR Part 11, EU Annex 11, and ALCOA+ data integrity principles. See the Regulatory Guidance Library.

Yes. Approvals are captured with electronic signatures, and every activity is recorded in a complete audit trail, supporting 21 CFR Part 11 and EU Annex 11 requirements. See the security and governance controls.

OnShore Technology Group, the developer of ValidationMaster^®, offers four Enterprise Validation Services:

• ValidationPro^℠ Enterprise Validation Delivery Services^™
• ValidationCoach^℠ Enterprise Validation Advisory Services^™
• ValidationExpert^℠ Specialized Validation Experts On Demand^™
• ValidationOffice^℠ Enterprise Validation Resource Services^™

Every engagement is powered by the ValidationMaster^® Enterprise Digital Validation Platform^™ and OnShore’s Lean Validation^® methodology.

Choose ValidationPro℠ for end-to-end validation delivery, ValidationCoach℠ for advisory support and mentoring of your internal team, ValidationExpert℠ for specialized experts on demand, or ValidationOffice℠ for validation resources and staff augmentation through the RightSourcing™ methodology. Every engagement is powered by the ValidationMaster® platform. Compare the engagement models.

Visit the Contact Us page and choose “Software Demonstration” as your inquiry type, or call +1.312.321.6400. Your request is routed to the right ValidationMaster^® specialist to schedule a personalized platform demonstration.

Existing customers can log in to the Support Portal to submit a support request or track an existing ticket, or call +1.312.321.6400. Don't have a login yet? Email support@validationmaster.com and our team will set up your access once we confirm your account. Our support team is available Monday to Friday, 8:00 a.m. to 5:00 p.m. Central Time. Visit Customer Support.

The Validation Knowledge Center™ brings together the Validation365™ Executive Webinar Series™ (free and on demand), white papers, case studies, regulatory guidance, and more. Browse the Knowledge Center.