Life Sciences

Invigorate your quality risk processes

sphera-industry-icons_life-sciences-grayAs customer expectations and regulatory scrutiny continue to rise, the need to improve product and quality processes has become critical in the life sciences industry. More complexities are being introduced into the system, such as drug-device combinations and advanced coating materials. To develop and manufacture effectively, you need a risk based approach to development and manufacturing.

Drive profitable growth with a proactive approach

Sphera solutions help companies strengthen and improve their quality risk processes – 18 of the top 25 global pharmaceutical companies and 9 of the top 10 global medical device companies rely on us to help achieve their operational objectives. By enabling proactive risk assessment methodologies such as Failure Modes and Effects Analysis (FMEA), we can help you identify and then design out potential failures and avoid costly recalls.

We support our customers by enabling them to close the gaps in their current programs, like reducing information that is contained in large unstructured documents which are difficult to search and query, and processes that are manual, labor-intensive and heavily reliant on specialized internal experts.

9 of the 10 Largest Pharmaceutical companies use Sphera to

  • Save time

  • Provide enterprise visibility to critical risks to enable informed decisions

  • Enable critical expert knowledge retention & sharing

  • Allow harmonized processes and measurement of all product quality risks

  • Link risk analysis across lifecycle stages from clinical hazard analysis to PFMEAs to Control Plans

  • Facilitate traceability for ease of compliance management

Managing Life Sciences Risk in a Single Solution

You see operational and quality risk in every facet of your business, including R&D, clinical trials, engineering, distribution, sales and marketing, and—most notably—production.

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Global Pharma Case Study

Pharmaceutical Company Reduces Quality Risks and Streamlines Processes for Regulatory Requirements

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Product Compliance Brochure

Empower your team to efficiently create GHS and REACH compliant SDSs and labels for global markets.

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Bring your Pharma Quality Management System to Life

Global healthcare company Baxter shares insights and best practices on Quality by Design to engineer risk out of your processes.

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Pharma Risk Management

Link risk analysis across lifecycle stages from clinical hazard analysis to PFMEAs to Control Plans.

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Improve consistency and comply with industry standards with the leading Failure Mode and Effects Analysis software FMEA-Pro.

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Why FMEA-Pro?

Learn more about FMEA-Pro … Why is it the right tool for the job? How does it facilitate your risk assessments? What makes it like the human brain?

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ISO14971 Compliance

Gain a competitive advantage by taking a lifecycle approach to ISO14971 compliance.

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Stature Quality Risk Management

Stature enterprise risk management platform enables you to drive better visibility and consistency.

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Siemens Award Winning Case Study

Siemens ensures GHS compliance and gains competitive edge.

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