Update your browser, this website may not display correctly.

Client Profile

FDA-regulated global pharmaceutical company

Business Challenge

An international pharmaceutical company with multiple plants had several manual processes in place, including hand documentation, Excel spreadsheets and Microsoft Word documents to report and track events, including defects and lab incidents. The inefficiencies were impacting the company’s ability to validate end products and was threatening their compliance with FDA regulations.

Project Objective

A multi-project, multi- quality management systems implementation, including Corrective and Preventive Actions (CAPA) and qualified event module implementation, was integrated to streamline preparation for regulatory audits, supplier quality management, and FDA compliance.

Built-in data collection, document handling, notification and escalation features, as well as training and documentation management, ensured reports, including defect reports and other related CAPAs, were routed for proper resolution, monitoring, and scheduling.

Delivered Results

LABUR’s quality management systems implementation and guideline documentation and training streamlined cross-functional areas of the business to ensure FDA-compliance. This elevated the pharmaceutical company’s brand reputation and integrity, strengthening their international reputation and export business.

Increased trust and satisfaction among suppliers and customers
Reduced cost of compliance to the business, including documentation that had been previously done manually
We have a very specific vision for not just what we want to get done but how we want to get it done. Darrin and his team took the time to understand that... They get what we’re trying to do here. They understand our environment.
VP of IT, Global Software Company

Case Studies

Our domain expertise spans industries and crosses functionalities within the enterprise.

The breadth of our industry experience runs deep, but our approach is targeted. We apply relevant best practices and tactical experience without compromising the unique circumstances of each company and project.