Manage your Quality Risk

Invigorate your quality risk process with a single solution.

Survival in the Life Sciences industry is defined by product and quality processes.

Are you managing quality risk effectively?

As a healthcare manufacturer, you know that risk has a way of defining your work. Manage it Effectively. 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. Without proper risk management, you can end up with impure medicines, poorly designed devices, or manufacturing errors that could result in product recalls, which on average in the life sciences industry cost $10 Million! With regulations becoming ever more stringent, you need to be prepared for the future.

We deliver automated solutions that manage compliance, risk and product stewardship for Life Sciences manufacturers.

At Sphera Solutions, we have more than 30 years of experience and industry-leading products to help chemical manufacturers manage risk efficiently and effectively—and generate insights our competitors can’t.

's Solutions:

1 Million Users

2,500 Customers

70 Countries

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We Deliver Insights and Deep Experties to Improve all your Processes, in a way Other Vendors Can’t

Adopt a Comprehensive Approach to Managing Operational Risk

Facilitate traceability for ease of compliance management with an Operational Risk solution that takes the entire Operational Risk journey from compliance through Operational Excellence, including Comply Plus, our regulatory standards solution.

Enable ‘Quality by Design’

Our Stature Quality Risk Management (QRM) solution provides a systematic approach to quality risk management as outlined in the ISO 14971 and ICH Standards. Furthermore, Stature enables Quality by Design by using scientific understanding of Drug Substances and Pharmaceutical Products.

Save Time and Simplify Compliance and Reporting Requirements

Provide enterprise visibility to critical risks to enable informed decisions. Chemical Lifecycle Management and SDS Authoring for Life Sciences companies, as part of Sphera’s Product Stewardship solutions.

Average Efficiency Gains 50%
with Sphera’s Quality Risk Assessment Solutions

Sphera and global healthcare company Baxter share insights and best practices on Quality by Design to engineer risk out of your processes.

 

Handle Quality Risk Effectively and Drive Profitable Growth

Our Stature Quality Risk Management solution is the industry standard for life sciences companies. We’ve helped pharmaceutical, biotech, and med device firms save millions of dollars in reporting costs by setting a single, standardized quality risk solution for the entire enterprise. That’s not to mention the reduction in prohibitively expensive recalls and product waste Stature has helped prevent.

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9 of the 10 largest medical device companies and 18 of the top 25 global pharmaceutical companies use Sphera for their quality and operational risk management needs.

Ensure shared, appropriately linked risk assessments to meet regulation-mandated traceability requirements and get electronic approvals in accordance to 21 CFR Part 11.
Not only does our QRM solution capture and retain expert knowledge, but also creates a comprehensive knowledge base of experiences, ensuring you learn from errors instead of just enduring them.
Stature’s workflow capabilities allow for assignment of ownership of corrective actions, and tracking them to closure. Stature can also ensure verification and existence of required controls to drive down risk.
Sphera’s QRM solutions feature standardized definitions and applications of the occurrence, severity, and detection in calculating risk, illustrating increased visibility of your quality risks. Better still, you can produce quality risk management reports and dashboards that reveal risks you otherwise may not have detected.
Stature shortens the time it takes to conduct risk assessments and turns a months-long exercise to produce reports to minutes. On average, Stature delivers a 50% efficiency gain in risk assessment.
Access a store of knowledge unlike any other. The content you get through a community of industry leading peers and Sphera domain experts will accelerate your next round of continuous improvements.
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Hear from our Customers

“The Sphera solution provides us with visibility into risks across all divisions and sites, enabling management to easily understand top risks and control the associated prevention strategies”

“We had to implement the classification across all of our 3,500 reagents. Sphera met the challenge by enabling our Siemens team members to evaluate the chemical make-up of each product, including a great deal of toxicity data. Fortunately, we were able to use the information that was available in Sphera’s solution to simplify the classification process.”

“With the Sphera solution data is centralized in one location and relationships are built between data elements to achieve traceability required by regulatory agencies… It helps to quantify the most risky parts of the manufacturing process and potential impact to patient safety.”

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Want to get started with managing Life Sciences risk in a single solution?

Global Pharm
Case Study

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Quality Risk Brochure

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Siemens
Case Study

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