Teuto Case Study

Pharma Innovator Leverages Digital CPV to Boost Statistical Control and Cut Reporting Time from Two Weeks to Three Days.

Case in Brief

Laboratório Teuto, a pioneer in the Brazilian pharmaceutical industry, sought to enhance its continued process verification (CPV) activities through digital transformation. Faced with the challenges of a manual, error-prone system and driven by a commitment to environmental responsibility, Teuto implemented ValGenesis to streamline data management, ensure data integrity, and enable real-time process monitoring. The solution drove significant improvements in the company’s CPV processes.

Results Highlights

• Achieved real-time process monitoring with automated alarms, increasing statistical control

• Accelerated periodic reporting from two weeks to three days, significantly reducing manual workload

• Reduced CPV team size from 16 to 5

• Enhanced data integrity through robust data access controls and audit trails

Customer Profile

With a rich history spanning over 70 years, Laboratório Teuto operates the largest pharmaceutical complex in Latin America, manufacturing a vast quantity of tablets, capsules, injectables, liquids, and creams monthly. The first company to produce generics and OTCs in Brazil, Teuto not only dominates the national market but also exports to various countries globally.

Headquarters: Anápolis, Goiás, Brazil
Employees: 3,500+
Founded: 1947
Featured Activity: Digital Continued Process Verification

Pre-Digital CPV Challenges

Before implementing ValGenesis, Teuto faced several challenges in its CPV activities. The process was labor-intensive and required significant time and effort. Data capture was manual, involving the extraction of results from the ERP system into a Microsoft Excel file, where Teuto organized and compiled the data chronologically for each critical quality attribute (CQA) and selected reference lots.

After organizing the data, Teuto transcribed it into statistical software for graph preparation. The compiled graphics were then inserted into a Microsoft Word document alongside a detailed analysis of the data. This multi-step process consumed considerable time and carried a high risk of data compilation failures.

Another challenge was the delayed identification of control excursions. Prolonged identification times hindered investigations, making it difficult to determine root causes, and often left the causes of excursions unexplained.

Additionally, Teuto spent one and a half days on data compilation and graphics execution per product, involving a team of 16 people—10 for data collection and graphics execution and six for reviews and reports. The focus was heavily skewed toward data compilation rather than investigations and improvements.

Industry Insights
As the global pharmaceutical market continues to expand, regulatory bodies are tightening requirements for data integrity and process validation, prompting companies to adopt robust CPV systems.

Digital transformation in CPV not only improves data accuracy and real-time monitoring but also supports agile decision-making and compliance with evolving regulatory standards such as FDA 21 CFR Part 11 and EU Annex 11.

As the industry moves toward Pharma 4.0, leveraging advanced analytics, AI-driven insights, and interconnected data systems becomes imperative for enhancing operational efficiency and maintaining a competitive advantage.

Teuto’s Goals for Implementing ValGenesis

Teuto had clear objectives when it decided to implement ValGenesis to enhance its CPV activities. Specifically, the company aimed to:

Ensure data Integrity:

Teuto sought to minimize errors and enhance data accuracy and integrity by integrating a robust digital solution.

Improve compliance:

Achieving full compliance with regulatory guidelines and recommendations, including the FDA’s 2011 Process Validation Guidance, ISPE’s GAMP 5, PDA’s TR-60, and Anvisa’s Resolution RDC No. 658 and Normative Instruction IN No. 138, was critical.

Streamline CPV Plans:

Teuto aimed to simplify CPV plans for a large number of products through a straightforward, user-friendly workflow.

Real-Time Monitoring:

The company wanted the ability to monitor the state of processes at any time using routine monitoring panels.

Automate CPV Processes:

A key goal was to automate CPV by integrating various systems for data registration, collection, and storage with the digital CPV system.

Accelerate Reporting:

Teuto sought to make periodic reporting faster and more efficient.

Efforts and Opportunities During Implementation

Integrating Teuto’s existing data systems with the ValGenesis database played a significant role in the implementation. This integration enabled automatic, real-time monitoring and trend assessment, significantly enhancing data management efficiency. The team spent approximately six months meticulously identifying and preparing the data to ensure the ValGenesis platform could accurately interpret it.

During the implementation, the team identified several opportunities for enhanced productivity. The new digital system simplified data organization and visualization. By implementing alarms with automatic notifications to responsible users, they streamlined the monitoring process. Creating templates and scheduling report generation accelerated the reporting process. Additionally, the ability to monitor processes in real time without delays improved responsiveness and decision-making.

Validation Supervisor Patrícia Watanabe noted, “Implementing ValGenesis has transformed our approach to CPV. The integration of our data systems and the comprehensive training from the ValGenesis team have empowered our users, ensuring we meet regulatory standards while enhancing efficiency and data integrity.”

The ValGenesis Professional Services Team conducted comprehensive training sessions to facilitate effective use of the new platform. They also provided ongoing support, answering questions as they arose. This training has significantly impacted user adoption, with eight users actively engaged in CPV and four from the IT team operating from a single site.

Additionally, new SOPs were developed to reflect the digital processes, ensuring that all team members were aligned with the updated workflows. The system was also subjected to pilot testing in a controlled environment to validate data integrity and overall functionality, confirming that the implementation met Teuto's expectations and operational requirements.

Overall, implementing ValGenesis not only streamlined Teuto's CPV activities but also laid a solid foundation for future improvements in data management and regulatory compliance.

Before and After: The Transformation

Teuto’s transformation from manual to digital CPV has led to significant improvements. Robust access controls and audit trails have virtually eliminated the risk of data integrity failures. Real-time monitoring has replaced delayed trend identification, enabling faster recognition of issues and opportunities for improvement. Teuto can now select reference batches by simultaneously analyzing all available critical attribute data. This multivariate analysis enhances the safety of choosing reference batches that accurately represent product behavior.

Automation and integration have greatly reduced the time and effort required for data compilation, allowing Teuto to concentrate on critical investigations and continuous improvements. Scheduling periodic report generation has also proved to be a substantial time-saver. Additionally, configuring statistical signals, such as the Westgard Rules, ensures immediate detection of any deviations. These alarms automatically notify responsible users by email, facilitating prompt action.

Looking Ahead

Teuto plans to expand access to ValGenesis across the development, production, and quality teams. This expansion will enable these teams to view the statistical control of products and approve reports, further enhancing collaboration and oversight.

Currently, the system is being utilized to evaluate all changes in processes and methods—an application that exceeded initial expectations. By broadening access and integrating additional teams, Teuto aims to strengthen its data-driven decision-making capabilities and ensure consistent quality throughout the production lifecycle.

As Teuto continues to embrace digital transformation, the company is committed to leveraging ValGenesis to enhance operational efficiency and maintain its competitive edge in the pharmaceutical industry.