Meeting Compliance Deadlines with Confidence

The client is a global pharmaceutical company with manufacturing facilities and regulatory operations spanning multiple regions. Their enterprise applications manage critical functions such as drug batch manufacturing records, compliance documentation, deviation tracking, and regulatory submissions to authorities like the FDA and EMA. Given the regulatory sensitivity, application performance and stability are mission-critical to maintaining audit trails, ensuring data integrity, and supporting production continuity.

With growing data volumes, rising regulatory complexity, and increased user concurrency across global locations, the application began to exhibit performance degradation during critical workflows—particularly batch approvals and regulatory document generation. These slowdowns:

• Threatened compliance timelines
• Introduced risk in meeting regulatory requirements, including FDA 21 CFR Part 11
• Impacted productivity across global teams during peak operational periods

A structured, multi-phase performance engineering strategy was designed to test and enhance system responsiveness and reliability under realistic usage conditions. The key initiatives included:

• Identifying mission-critical workflows
• Executing load, spike, stress, and soak tests
• Optimizing SQL queries and enhancing application caching

The performance testing initiative delivered measurable improvements in scalability, compliance readiness, and operational efficiency:

• Achieved sub-3-second response times for 90% of high-priority transactions during peak concurrent usage
• Reduced batch approval cycle times by 30% through backend optimizations

  Completed a 12-hour soak test without any memory leaks, connection drops, or CPU saturation

• Increased API throughput by 45%, enabling seamless synchronization with third-party systems and regulatory portals
• Strengthened system readiness for global audits and future regulatory expansions