Software Consulting Services
Continuous Validation Program
Rely on Strategic’s 25+ years of specialized software validation consulting, trusted by life science organizations. Our proven methodology—supported by a comprehensive validation toolkit—ensures compliance, mitigates risk, and scales seamlessly with your organization’s growth, from startup through commercialization and expansion.
Strategic Validation Software & Services
Software Assurance
Risk Mitigation
Strategic has always focused on a Risk-Based Software Validation approach, consistent with the FDA Computer Software Assurance approach.
Eliminate Protocols
Quick ROI
Eliminates need to create validation protocols, scripts and documentation in-house from scratch.
Made For You
Flexible Service Offerings
Clients have the flexibility to lead their own validation efforts using Strategic’s comprehensive Validation Toolkit with limited guidance, or to engage Strategic directly for full execution of the validation package.
Proven Experience
Low Risk, Proven Solution
We have worked with hundreds of Life Sciences clients, giving them peace of mind by meeting regulatory guidelines to validate their NetSuite ERP system.
Strategic offers a cost-effective approach to validate your initial NetSuite implementation and ensure ongoing compliance with validation requirements through every system upgrade. By leveraging our NetSuite Software Validation Toolkit, proven Validation Methodology, and experienced consultants, we help keep your validation documentation aligned with regulatory expectations—without revalidating from scratch.
Removes the burden from clients to review, assess, and mitigate cGMP impact for each twice-annual NetSuite release
Provide a cGMP Impact Analysis Report summarizing new cGMP-related features and adjustments introduced in each release
Establish a clear foundation for Risk Assessment activities, supporting informed decision-making and regulatory alignment
Update the Validation Toolkit with each NetSuite release to reflect current functionality and maintain compliance readiness
NetSuite Software Validation Made Simple
Strategic Validation Toolkit
Our validation toolkit provides everything you need to achieve and maintain compliance with FDA and industry regulations. From initial planning through ongoing support, we deliver structured documentation and protocols designed to streamline audits and reduce risk. What’s Included:
Project Management
Computer Systems Validation Plan (CSVP) & Addendums
Functional Requirements Identification
Risk Assessment
Traceability Matrix
Baseline Configuration
Operational Qualification Protocol / Test Scripts
Performance Qualification Protocol / Test Scripts
Data Migration Protocol
Final Validation Report
Ad Hoc Ongoing Software Validation Assistance
Ready to Get Started?
Stay ahead of regulatory requirements with a complete software validation package that reduces risk, shortens audits, and ensures confidence in every system upgrade.
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ERP Services
Services from the ERP Pros. From application consulting and validation, to 24/7 ERP support services, Strategic has you covered.
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Industry Specific ERP
Strategic speaks your industry’s language. With decades of ERP experience, our team knows how to foster operational excellence in your industry.
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Managed Support Services – SIGSERV APP
Round the clock support services for complete peace of mind.