Case Studies
Document Management System
Client
Qualitest
Industry
Pharmaceutical
Business Challenge
To develop a more efficient document change process
Background
Qualitest, a leading manufacturer of high-quality, affordable generic pharmaceuticals, aimed to improve the efficiency of its document change process. At the time, document changes were averaging 50 to 60 days to complete. The company sought to implement a compliant, streamlined process with significantly faster turnaround times.
RCA Approach
Regulatory Compliance Associates® Inc. (RCA) was engaged to assess and enhance the existing document change process. RCA quickly conducted a comprehensive analysis to identify bottlenecks and areas for improvement. In collaboration with Qualitest, RCA revised the applicable standard operating procedures (SOPs) to support a more efficient workflow. Training was conducted for both end users and management, and the new SOPs were piloted to evaluate effectiveness in real-time operations.
RCA’s wealth of knowledge about our document management system & document control helped us speed up our process, halving the turn-around time.
Result
The pilot was successful and provided valuable feedback for minor refinements. Following the pilot, the improved process was implemented company-wide. As a result, document changes at Qualitest are now completed in under 30 days on average—and often even faster—representing a significant gain in operational efficiency while maintaining full compliance.
