Revamping Microbiology Testing for a Leading Pharmaceutical Organization
Overview.
The client is a pharmaceutical company giant with a major focus on development and manufacture of IP-led niche finished dosage formulations. They were facing challenges in managing paper-based stock and issuance logbooks, leading to manual errors, compliance risks, and inefficiencies. These outdated systems lacked real-time data recording and posed challenges during FDA audits. They partnered with us to digitalize the existing workflows & revamp MLT to comply with regulations.
The client wanted to reimagine their Laboratory process to improve productivity and reduce delays.
The existing research process used a complex Microbial Limit Test (MLT) to detect microorganisms in drug samples at various stages.
The process required either internal media preparation or third-party purchase, inventory management, sample preparation, incubation, observation recording, and investigations if abnormal growth is detected.
The client relied heavily on paper-based and manual methods for testing across their four sites, making them vulnerable to GxP (GoodxPractice) compliance.
Solution
We provided the client with a custom digital solution within the Laboratory Information Management System (LIMS) which eliminates paper, automates processes and reduces errors.
The solution included a site-specific homepage for centralized media master access and automation capabilities for media purchase and inventory management.
Facilitated automatic retrieves media information for each MLT test, auto-reconciles stock quantity post-utilization, and tracks incubation temperatures and timings.
The system's ability to post results in the LIMS system eliminated manual transcription and the possibility of human error in a GxP (GoodxPractice) mandated FDA-regulated manufacturing unit.
The Impact
100%
Digitalization
80%
Audit Time Reduction
100% digitized process with the complete elimination of paper logbooks enabling mandatory GxP compliance in Pharma Industry.
80% reduction in audit preparation time which includes FDA audits due to completely digitized, ‘FDA audit-ready’ process.
Increased microbiology lab sterility with the elimination of hardcopy documents.
Reduction in the carbon footprint with the elimination of paper and outdated systems.
