Honeywell (Nasdaq: HON) launched Honeywell Product Quality Review, an innovative software solution for manufacturers of medical products. The solution is designed to automate and streamline the Annual Product Quality Review (APQR) process, enabling medical organizations to efficiently assess the quality of their products and more efficiently meet regulatory requirements.
Honeywell Product Quality Review is the first of a series of applications in the new Honeywell Life Sciences Applications Suite, each designed to enable rapid digital capabilities and drive business outcomes at scale to improve product quality and patient safety. It replaces paper-based processes, automating data collection from various systems of record, saving valuable time and improving data integrity. Research from McKinsey & Company indicates that approximately 30% of staff time in the pharma industry is spent on documentation-related activities such as product dossiers, machine logs and batch records, with biotech batch records sometimes consisting of 5,000 to 45,000 manual entries.
“In our business, there is nothing more important than quality. Working with Honeywell allowed us to sunset many of our manual practices and embrace a digital path forward for our quality review processes,” said Yolisha Singh, Release and Outsource Manager, Biovac. “For us, the Honeywell Product Quality Review app has been a time-saving tool that’s helped us focus on identifying improvements so we can be more effective and efficient as a business.”
Under FDA and other global regulatory guidelines, pharmaceutical companies are required to review and assess the quality of their medical products annually. Inefficient APQR programs can result in a time-consuming process of collecting the data from multiple systems and sites and then conducting a manual review, analysis and approval, months after initiating data collection. Poor APQR practices can potentially present unnecessary risks to patients and regulatory actions.
“APQR shouldn’t be a burdensome effort – so we are pleased to provide a solution that simplifies the process and empowers medical product manufacturers to not only meet their regulatory requirements but also turn a traditionally retrospective analysis into a timelier decision support tool,” said Dr. Oxana Pickeral, vice president and GM, Connected Life Sciences & Logistics, Honeywell Connected Enterprise. “This allows customers to focus on insights over process and deliver high-quality products more quickly to market and the patients they serve.”
Honeywell's digital solution fosters cross-functional collaboration with real-time reviews and approvals across internal teams and third-party providers. Business users now have an on-demand perspective of their product quality and can focus on analyzing the data for trends to uphold high-quality standards with increased efficiency.
