RTSM Setup & UAT
Systems that pass inspection
RTSM Setup & Configuration
We configure RTSM systems to align precisely with your protocol. Ensuring randomization logic, dispensing rules, resupply triggers, and inventory flows support trial execution from day one.
What we deliver
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Protocol aligned system configuration
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Dispensing, resupply, and return workflows
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Shipment and inventory optimization
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Inspection-ready system documentation
User Acceptance Testing (UAT)
We execute risk-based UAT that confirms your RTSM system performs as required in practice. Testing begins with protocol and URS review, building requirements and test cases directly in our ISO-certified test management platform.
What we deliver
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Risk-based test coverage of critical functions and protocol-specific scenarios
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Focus on patient safety, data integrity, and operational reliability
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Complete documentation package: UAT Test Plan, executed Test Cases, Test Report, Certificate of Completion
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SOP-driven processes aligned with FDA, EMA, GCP IWG, and GAMP-5
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Structured stakeholder communication and alignment meetings
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Rapid issue management and retesting
Why Sponsors Choose SPLY
What We Provide
Value Delivered
Unbiased validation
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Our Process
sply.
Track Record
50+
UAT projects completed
Across Phase I-IV trials in oncology, rare disease, CNS, cardiovascular, and metabolic indications.
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major inspection findings
Regulatory confidence through methodical validation and comprehensive documentation.
40%
faster UAT cycles
Centralized test management and reusable script libraries accelerate validation without compromising quality.
Technical Capabilities
Platform experience
4G Clinical, Merative, Medidata, Oracle, Almac, and more.
Compliance standards
FDA 21 CFR Part 11, EMA Annex 11, ICH GCP, GAMP-5, ISPE guidelines, ISTQB testing principles.
Documentation standards
Complete audit trails, version control, electronic signatures, and TMF-ready documentation packages.
