As 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.
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.