How a Preferred UK Generic Pharmaceutical Company Transformed APQR Management Across 6 European Countries

About Client

This client is one of the few generic pharmaceutical companies highly regarded by healthcare practitioners in the UK for their efficiency and agility in managing the medicine supply chain. They hold over 100 product licenses across 6 European countries. With such an extensive portfolio, the complexity of managing Product Quality Reviews (APQRs) and ensuring accurate, timely submissions to regulatory agencies posed significant challenges. 

The Hassle

Complex PQR Management

Complex PQR Management

Managing the APQRs for more than 100 products annually was daunting. This involved collecting comprehensive data from various sources, compiling trend analyses, and submitting detailed lifecycle data. 

Manual Data Handling

Manual Data Handling

The existing process relied heavily on Excel spreadsheets, where data was manually collected and compiled from different sources. This made the process complex and time-consuming and increased the risk of errors.

High User Expectations

Users expected advanced systems to automate PQR generation, allowing them to focus on reviewing and writing conclusions rather than handling data manually. 

 

Edging out with QEdge: (APQR)

The company sought to digitize and automate its APQR processes to tackle these challenges. This approach aimed to reduce paper usage, increase efficiency, and enhance accuracy. 
Digitization: 
We proposed an electronic system with a pre-defined workflow, enabling users to seamlessly prepare, review, and approve PQRs within a controlled system. 
Automation: 
Leveraging automation tools, we improved the readiness and efficiency of the process. Automation reduced the time required for data handling, increased process accuracy, and streamlined operations. 

Tackling the Challenge

Understanding URS: We began by thoroughly understanding the User Requirement Specifications (URS) to ensure the solution met all client needs. 

Functional Challenges: We addressed functional challenges by conducting collaborative workshops to tailor the platform to the client’s specific requirements. 

Implementation: The project was divided into multiple phases and went live after rigorous testing and validation to ensure regulatory compliance and functionality. 

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Digital Transformation Business Impact

Following the deployment of our solution, the company experienced significant improvements:

  1. Audit readiness improved by 85%. 
  2. Work efficiency increased by 80%. 
  3. Time consumption was reduced by 80%. 
  4. Process accuracy was enhanced by 95%. 

Future Opportunity: 

New capabilities were added to the platform to support various automation use cases, ensuring ongoing improvements and adaptability to future needs. 

About QEdge

With QEdge, bring all the quality processes such as Change Control, Deviation, Investigation, CAPA, Market Complaints, OOS, OOT, Risk Assessment and other quality related activities like SOP management, Training management, Audit management, Vendor qualification and PQR/APQR on a single platform. 

 

Experience a Digital Transformation journey with a trusted automation and digitization partner. To start, email us at sarjen@sarjen.com or visit qedge.sarjen.com. 

 

Sarjen Systems has been serving the Pharma & Life Science industry for the last 25 years. We keep updating our products on a regular basis to serve our customers with products that are compliant. Our products are greenfield products and technologically updated as per requirements.