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FDA Compliance

Honeywell Launches Product Quality Review Automation Application

Streamlines annual regulatory review for life sciences

Published: Thursday, October 26, 2023 - 11:00

(Honeywell: Atlanta) -- Honeywell has launched Honeywell Product Quality Review, an innovative software solution for manufacturers of medical products. It’s designed to automate and streamline the annual product quality review (APQR) process, enabling medical organizations to efficiently assess the quality of their products and 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 & Co. 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 5,000–45,000 manual entries.

“In our business, there is nothing more important than quality,” says Yolisha Singh, release and outsource manager for Biovac. “Working with Honeywell allowed us to sunset many of our manual practices and embrace a digital path forward for our quality review processes. 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 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,” says Oxana Pickeral, vice president and general manager for Connected Life Sciences & Logistics at 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.

To learn more about the solution, visit the Honeywell Product Quality Review page.

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For 40 years Quality Digest has been the go-to source for all things quality. Our newsletter, Quality Digest, shares expert commentary and relevant industry resources to assist our readers in their quest for continuous improvement. Our website includes every column and article from the newsletter since May 2009 as well as back issues of Quality Digest magazine to August 1995. We are committed to promoting a view wherein quality is not a niche, but an integral part of every phase of manufacturing and services.