POLARION

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TRANSFORMING ALM IN THE LIFE SCIENCES INDUSTRY

CG excels in implementing Polarion Software, enhancing product development and risk management for businesses amid rapidly evolving technological landscapes. Addressing the complexities of modern medical device technologies, CG facilitates the creation and management of multi-disciplinary requirements (from mechanical to software and labeling) and oversees extensive risk processes, including Hazards Analysis and a wide spectrum of FMEA assessments, in addition to Verification and Validation Testing. Leveraging top-tier digital thread capabilities, CG provides deep insights through visualizing traceability, impact analysis, and test coverage, ensuring product design excellence for patients, providers, and regulators. Polarion Software, a flexible and wholly browser-based platform, fosters innovation across dispersed teams, bridging the processes of design, build, test, and management. It guarantees seamless traceability and visibility throughout the application lifecycle, consolidating application development for teams of any size under a singular platform.

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SaMD and SiMD

Product software development
and Risk Management Lifecycle

PROCESS VALIDATION

PV Lifecycle with Process Design, OQ and PQ including pFMEA for end-to-end process validation

CSA and CSV

CSA/CSV Lifecycle with automated test strategy, risk management & end-to-end CSA docs for non-product SDLC

EQUIPMENT QUALIFICATION

Onboarding and validating manufacturing and laboratory equipment/ systems for their intended use

DESIGN CONTROL

Product Design, Development, Risk Management and Design Verification/Validation

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ADVANCING DIGITAL TRANSFORMATION IN ALM

COMPUTER SYSTEM VALIDATION

By Leveraging CG's Turn Key managed services, we have validated over 500 different systems

DESIGN CONTROL AND RISK MANAGEMENT

CG synthesizes business process expertise with technology to error proof, streamline, accelerate and integrate all aspects of design control and risk management

EQUIPMENT/PROCESS VALIDATION

CG consistently monitors and evaluates the performance processes to ensure that the manufacturing operations for the product remain in a controlled state.

POLARION RESOURCES

Talk to our experts

Serving customers around the globe

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