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UVD GMP Validation Package
Qualification Made Easy
Streamline the integration of the UVD Robot Pharma into your regulated cleanrooms and GMP environments. Our comprehensive UVD GMP Validation Package provides the complete documentation framework required for faster site implementation.
The package includes 8 ready-to-use validation documents designed to meet GMP standards. To further simplify your rollout, you can also opt for full execution support for three key protocols: Installation & Operational Qualification (IOQ), Requalification, and the Cycle Development Form. Partner with us to minimize qualification timelines, reduce compliance risks, and get your UVD Robot Pharma operational in record time.
VALIDATION PLAN
This Validation Plan defines the qualification strategy for the UVD Robot Pharma. It establishes the scope and responsibilities of Blue Ocean Robotics in supplying and executing a qualification package and identifies the end-user-owned site requirements to achieve GMP compliance.
USER REQUIREMENTS SPECIFICATION
This User Requirements Specification (URS) defines the functional, operational, safety, and data integrity requirements for the UVD Robot Pharma system at your site. This document serves as the foundational basis for system configuration, risk assessment, qualification, and routine lifecycle management.
SYSTEM RISK ASSESSMENT
This System Risk Assessment (SRA) identifies and evaluates risks to Critical Quality Attributes (CQAs), data integrity, and patient safety associated with the design and operation of the UVD Robot Pharma. The output of this assessment directly dictates the required design controls and establishes the strict scope of formal qualification testing required for GMP release.
DESIGN QUALIFICATION
The purpose of this Design Qualification (DQ) is to document that the design of the UVD Robot Pharma meets all approved User Requirement Specifications (URS) and effectively mitigates the quality and data integrity risks identified in the System Risk Assessment (SRA).
FACTORY ACCEPTANCE TEST
The Factory Acceptance Test (FAT) verifies that the UVD Robot Pharma is assembled, configured, and tested before shipment. It provides documented evidence that
Blue Ocean Robotics completed the required FAT-defined assembly checks, software setup checks, safety checks, movement checks, charging checks, and UV-C checks.
INSTALLATION AND OPERATIONAL QUALIFICATION
The purpose of this Installation and Operational Qualification (IOQ) is to verify that the UVD Robot Pharma system is installed correctly at the End User site and operates as intended for qualification-ready use in accordance with the approved Validation Plan.
CYCLE DEVELOPMENT FORM
The purpose of the form is to record additional room-specific disinfection cycle, dosimeter placement and UV-C dose results to document that the cycle meets its defined targets.
REQUALIFICATION PROTOCOL
The purpose of this Requalification Protocol is to verify that the UVD Robot remains in a qualified state for continued GMP use. This protocol is executed after requalification has been initiated through periodic review, change control, deviation, maintenance activity, or other End User QMS processes.
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Reach out today to discover how our UVD GMP Validation Package helps you deploy UVD Robots faster and maximize productivity.
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