Introduction
Tamro, a leading pharmaceutical and health product distributor in Finland, has a mission to deliver health by distributing pharmaceuticals and health products to hospitals, pharmacies, and retail stores across the country. In addition to its core distribution services, Tamro also offers data-driven solutions, sales and marketing services, and digital home care solutions.
In today’s fast-paced world, the pharmaceutical and healthcare industries are relying more than ever on computerised systems to ensure efficiency, accuracy, and compliance. These systems are at the heart of operations, managing everything from manufacturing and quality control to inventory management and compliance. To maintain the highest standards of quality and safety, companies like Tamro need robust Computerised System Validation (CSV) processes in place. Ensuring the efficiency and accuracy of its operations is paramount, especially in the context of computerized systems validation. To improve this critical aspect of their operations, Tamro partnered with Feicon, represented by Jari Suhonen, a renowned Kuopio based Finnish expert services provider. Jari played a pivotal role in managing the audit of Tamro’s computerized system validation process. Jari’s expertise in validation and quality development made him well-equipped to lead the assessment. His primary objectives were to evaluate the current state of the validation process and associated documentation and provide recommendations for corrective actions.
In this blog, we will explore how Tamro embarked on a project to improve their CSV process with the help of Feicon Oy, led by Jari Suhonen.
Project Overview
The objective of the project was clear: Recognise areas where Tamro’s CSV process could be improved and implement corrective actions. Feicon Oy, with Jari Suhonen at the helm, was entrusted with the responsibility of managing the audit and evaluating the current state of the CSV process and documentation.
Methodology
To accomplish this goal, the project team at Tamro, along with Feicon Oy, adopted a comprehensive approach that included three crucial components:
- Group Interviews: Three separate group interviews were conducted, each focusing on a distinct aspect of the CSV process.
- Validation Management: This group delved into the strategic aspects of CSV, assessing how the process was managed, including planning, resource allocation, and risk assessment.
- Quality and Effectivity: Here, the team examined the quality control measures in place, ensuring that the systems meet regulatory and quality standards while optimizing efficiency.
- Compliance: The third group interview focused on ensuring that Tamro’s CSV process aligns with industry regulations and standards, minimizing the risk of non-compliance.
- Documentation Review: In addition to the interviews, a thorough review of validation protocols and documentation was undertaken. This step was critical in understanding the depth and breadth of Tamro’s current CSV process.
What We Achieved
Collaborating closely with Tamro’s System and Validation Experts, Jari Suhonen and Feicon Oy identified several areas for improvement within the three categories mentioned above. These development opportunities covered a wide range of aspects, including process optimization, documentation enhancement, and alignment with industry best practices.
The partnership culminated in Jari Suhonen providing a set of actionable recommendations to improve Tamro’s computerized system validation process. These recommendations were tailored to address the specific areas for improvement identified during the audit, ensuring that they were practical and achievable.
Experience of Audit
The project was an exciting opportunity to bridge two critical areas – Computerised System Validation and Process Development/Lean Six Sigma. By combining expertise in these domains, Tamro and Feicon Oy were able to identify opportunities for improvement that would not have been apparent otherwise.
In an era where technology plays a pivotal role in pharmaceutical and healthcare operations, ensuring the compliance of computerised systems is paramount. Tamro’s commitment to enhancing their Computerised System Validation process, with the assistance of Feicon Oy and Jari Suhonen, underscores their dedication to maintaining the highest standards of quality and compliance. Through this project, Tamro is better positioned to align regulatory requirements with agile methods of developing and maintaining computerised systems.
Customer comments:
“We need to be sure that our computerised systems do exactly, 100 %, what they are designed to do. Thus, validation of our computerised systems is essential and business critical. Before we introduce new systems, we always conduct thorough testing, sometimes hundreds of different test cases, and all of this is documented in detail. Any changes or modifications to our GxP-critical systems require either re- or change validation. These are mandatory processes, and we are proud to offer our customers top-quality service and user experience.
Jari’s references and background made us sure that he would be a great fit to evaluate the compliance of our CSV process. Indeed, the collaboration was efficient and positive feedback was given of the group interviews that Jari facilitated. In the end, we got many excellent recommendations and will surely adapt these to our processes to maintain the high quality we pursue and to minimize any risks of non-compliance.”
Leena Julin-Järvelä
Environmental and Validation Specialist, Tamro Oyj