Faster & Better
Compliance -
Transforming Pharma
QC Processes with
Intelligent Automation

About the Client

As a prominent player in the global pharmaceutical industry, with over three decades of experience, this pharma leader is renowned for its development, manufacturing, and marketing of generic drugs, active pharmaceutical ingredients (APIs), and biosimilars. The company operates over 30 state-of-the-art manufacturing plants worldwide, producing therapeutic solutions. Committed to quality and compliance with global health regulations, they continually seek automation solutions to streamline processes, improve accuracy, and ensure regulatory adherence.

Challenge

The pharma leader grappled with complex regulatory compliance, time-intensive documentation, and accuracy concerns in manual processes. Quality teams struggled with generating time-sensitive reports, scouring multiple systems for data spanning up to nine months per batch. The risk of human error in data compilation and analysis, coupled with strict 24-hour review and approval deadlines, posed significant threats to compliance and operational efficiency. These challenges demanded a more reliable, consistent, and rapid approach to quality control documentation.

Solutions

Cloud4C developed a comprehensive intelligent automation solution that seamlessly integrates with existing IT infrastructure, including LIMS and Empower systems. This intelligent workflow automation mimics human actions, operating 24/7 to extract and compile data without manual intervention. A custom, user-friendly dashboard interface streamlines data entry and ensures accountability. The solution also incorporates digital signatures for a streamlined approval process, meeting strict regulatory timelines while maintaining data integrity and preventing time manipulation.