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Quality Risk Assessment Software

Move beyond compliance, drive data consistency and improve efficiency.

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Manage risk, optimize quality and ensure compliance with the advanced capabilities Sphera’s centralized Quality Risk Assessment software. Standardize the recording of risk assessment data, while ensuring proper controls are in place. Utilize configurable templates, risk data management, central repositories, and a common risk language for proactive risk management and compliance.

Make proactive risk management a reality

Companies report 40% to 60% reduction in time and effort for quality risk assessment by leveraging standardized solutions such as Sphera Advanced Risk Assessment.

  • Avoid duplication with predefined knowledge-based repositories
  • Link quality metrics across decentralized processes
  • Streamline risk assessment with standardized capabilities
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ORM Module Graphics_Quality Risk Management – Make Proactive Risk Management a Reality

Empowering Excellence with Risk Templates

Sphera’s risk templates promote standardization through a common risk language and the flexibility to easily link and share information.

  • Perform comprehensive quality risk assessments
  • Accelerate productivity
  • Configurable frameworks for FMEA, PHA, LOPA, HAZOP, and SVA
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ORM Module Graphics_Quality Risk Management – Projects large and small

Drive data consistency and product reliability

Sphera’s Quality Risk Assessment software helps companies comply with various quality standards.

  • Assign roles, such as risk assessment facilitators, owners, editors and readers.
  • Real-time risk distribution and risk dashboards allow reporting on performance.
  • Ensure asset safety offline and access feature keeps productivity intact without internet.
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ORM Module Graphics_Quality Risk Management – Drive Data Consistency and Product Reliability


Centralize risk knowledge

Centralized access to knowledge libraries enhances team collaboration for traceability, compliance, and reliability control.

Efficiently conduct risk assessments

Configurable templates empower teams to uncover hidden risks and security gaps in a consistent, standard format.

Comply with regulations and industry standards

Unified risk and quality management with audit trail ensures compliance with regulations and risk legislation.

Report on Performance

Visualization tools offer enterprise access to a unified risk view, consistent metrics for control effectiveness, and common performance reporting.


Advanced Risk Assessment for Quality Risk Enables Holistic Process

Companies need to establish corporate standards and select a company-wide tool for managing quality risks. With Sphera’s ARA for Quality Risk, companies can ensure that the proper controls are in place to deliver high quality, reliable products faster and more safely and efficiently.

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Process Safety Report 2023

Our latest Process Safety Report takes a deep dive into the state of process safety and operational risk management across various industries.


ARA for Quality Risk Management

Product deficiencies can threaten human health and safety. Furthermore, recalls of drugs, medical devices, manufactured products or foods are hugely expensive


Reduce quality risk and streamline regulatory processes

To streamline data capture and risk assessment, a large pharmaceutical company engaged Sphera’s centralized risk assessment solution.


Bring your Quality Risk Assessment strategy into the future

In life sciences and pharmaceuticals, the quality risk management journey is never-ending. These businesses are exposed to profound risk.

Our Awards

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Best Digital Twin Technology

Finalist: ORM Digital Twin


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Operational Excellence Innovation Awards

Oil & Gas


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Green Quadrant

Leader: Process Safety Management Software


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Operational Risk Management Software


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Request a demo

Fill out the form and we will get back to you to discuss your risk management needs.



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Explore the modules
in this suite

Our enterprise-wide, fully integrated software reduces the likelihood of incidents and operational losses. Advanced software tools build workflows to capture, track, investigate, report and analyze health and safety information.


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