Validation Planning
Define scope, validation strategy, deliverables, and timelines for each system and program.
ValidationPro℠: Enterprise Validation Delivery Services™
We execute validation projects from start to finish on time and on budget, giving your enterprise programs one experienced, accountable partner from planning through go-live.
- 22+ Years Supporting Regulated Industries
- 300+ Validation Projects
- 3× Inc. 5000 Company
- FDA • EMA • MHRA Experience
Turnkey IV&V delivery
Turnkey Validation Project Execution
ValidationPro℠ delivers complete end-to-end validation execution for organizations seeking an experienced partner to plan, manage, and deliver enterprise validation programs. Our multidisciplinary validation teams assume responsibility for the entire validation lifecycle, from planning and documentation through testing, execution, traceability, and final validation reporting, allowing your internal teams to remain focused on strategic business priorities.
Accelerate Project Delivery
Move implementation programs forward with an experienced validation team built for rapid project execution.
Free Your Internal Teams
Your quality, IT, and validation staff stay on the work only they can do while OnShore executes the validation lifecycle.
Deliver Inspection-Ready Outcomes
Receive higher-quality, traceable, inspection-ready validation deliverables for each system in the program.
When to choose ValidationPro℠
When ValidationPro℠ Is the Right Engagement Model
Choose ValidationPro℠ when the scope, timeline, or complexity of a program is more than your internal team can take on. It is designed for enterprise programs that need an experienced partner to take on validation execution from start to finish.
Implementing ERP, eQMS, or another enterprise platform? Every CloudMaster 365™ Enterprise Validation Accelerator™ includes ValidationPro℠ Enterprise Validation Delivery Services™.
Ideal For
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Large Implementation Programs
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ERP Implementations
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eQMS Implementations
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Cloud Implementations
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Manufacturing Systems
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Organizations Lacking Internal Validation Resources
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Organizations Requiring Rapid Project Execution
What ValidationPro℠ delivers
One Accountable Team Across the Entire Validation Lifecycle
As a complete turnkey independent verification and validation (IV&V) service, ValidationPro℠ teams take responsibility for every stage of the validation lifecycle, from the first validation plan to the final summary report. Engagements cover computer systems validation (CSV) as well as facility and site, equipment and laboratory systems, and process validation. Your program gets a single point of accountability for scope, schedule, and deliverables.
Validation Documentation
Author requirements, risk assessments, validation plans, and test protocols aligned with FDA CSA and ISPE GAMP® 5 Second Edition guidance.
Testing & Execution
Execute IQ, OQ, and PQ test scripts and capture objective evidence digitally.
Traceability
Maintain end-to-end traceability from requirements through risk assessment, testing, and results.
Final Validation Reporting
Deliver the validation summary report and a complete, inspection-ready validation package for your approval.
Program Governance
Coordinate QA, IT, validation, and compliance stakeholders and keep leadership informed throughout the program.
ValidationPro℠ takes on end-to-end execution while your organization retains ownership of validation outcomes and methodology. Every deliverable is submitted to your team for review and approval.
Services Powered by ValidationMaster®
The Difference Isn't Just Our Consultants. It's the Platform Behind Them.
Unlike traditional consulting firms that rely primarily on manual documentation and disconnected tools, every OnShore engagement is powered by the ValidationMaster® Enterprise Digital Validation Platform™.
Because ValidationPro℠ engagements operate within the platform's structured environment, your data continuity and governance stay intact from planning through final reporting.
Human-Guided. AI-Assisted. Validation Professional-Approved.
Lean Validation® Methodology
Our proprietary Lean Validation® methodology eliminates unnecessary documentation while maintaining full regulatory compliance, helping organizations reduce validation effort without increasing risk.
AI-Powered Productivity
Leverage TestMaster AI™, intelligent automation, and digital workflows to accelerate document generation, testing, traceability, evidence collection, and reporting while keeping validation professionals in control.
Built-In Regulatory Compliance
Every engagement incorporates FDA Computer Software Assurance (CSA), ISPE GAMP® 5 Second Edition guidance, 21 CFR Part 11, Annex 11, ALCOA+, and global GxP best practices.
Enterprise Dashboards & Analytics
Real-time executive dashboards provide complete visibility into project status, validation progress, risk, quality metrics, and inspection readiness across your validation portfolio.
Explore all engagement models
Validation Engagement Framework™
ValidationPro℠ is one of four professional service delivery models from OnShore Technology Group, each solving a different business challenge. Choose the level of engagement that best fits your organization.
A Complete Ecosystem of Expertise. Powered by the ValidationMaster® Platform.
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Delivery
ValidationPro℠
Enterprise Validation Delivery Services™
End-to-end validation project execution, documentation, testing, implementation, and compliance delivery, on time, on budget.
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Advise
ValidationCoach℠
Enterprise Validation Advisory Services™
Strategic guidance, program mentoring, and best practices to drive validation success.
Explore ValidationCoach℠ -
Expertise
ValidationExpert℠
Specialized Validation Experts On Demand™
Independent assessments, audits, gap analyses, and regulatory expertise to ensure compliance and reduce risk.
Explore ValidationExpert℠ -
Scale
ValidationOffice℠
Enterprise Validation Resource Services™
Powered by the RightSourcing™ MethodologyHighly skilled resources and specialized support to extend your team and scale your validation capabilities globally.
Explore ValidationOffice℠
Validation consultation
Need Validation Expertise?
Whether you need project delivery, coaching, expert advisory services, or dedicated validation resources, we're here to help.
A guided conversation can help determine whether ValidationPro℠ aligns with your organization's validation needs and program goals.