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.
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.
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.
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.
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.
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.Let Us Help You
“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.”