"The SoftExpert Suite helped us streamline our processes and make our operations more agile. We managed to eliminate a significant amount of manual workload while maintaining full compliance with global quality standards and all the requirements of the pharmaceutical industry and regulatory bodies such as the FDA."

CEO of Laboratorios Zepol, María Alejandra López Yglesias

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Compliance with international standards

ISO 9001, ISO 14001 certifications, Esencial Costa Rica, and FDA-registered products.

Less paper, more agility

Paperwork was replaced by electronic forms and checklists.

Optimization of quality processes

Process management on a user-friendly and reliable platform.

Laboratorios Zepol is a Costa Rican company with over 70 years in the market, manufacturing pharmaceutical and personal hygiene products for customers worldwide. Its facilities are equipped with cutting-edge technology and were the first in the Central American region to achieve ISO 9001 certification (since 1998) and ISO 14001 certification (since 2008), demonstrating the organization's commitment to high-quality standards and environmental responsibility.

Kategoriler

Accelerated Growth and the Need for Automation

The global pharmaceutical industry has been experiencing growth in recent years, with the sector expected to reach $273.6 billion by 2032, according to Future Market Insights. However, to stand out in an increasingly competitive and highly regulated market, it is essential to advance digitalization, as it has the potential to sustainably transform operations, enabling automated management, optimizing processes, facilitating audits, and contributing to obtaining certifications.

Additionally, pharmaceutical companies generate a large volume of information, and often, documents quickly accumulate when using legacy information sources and isolated databases, making it difficult to search for and manage content. This challenge was also faced by Laboratorios Zepol S.A., which maintained documentation in printed format and controlled processes via Excel spreadsheets, spending time on management and administration, exposing the processes to human errors, as well as excessive document printing, which conflicted with its environmental policy.

Both the pharmaceutical industry and highly regulated markets, where the laboratory's products are sold, pose significant challenges in terms of compliance, systematization, and document volume. With this in mind, the company sought a solution that could support this digitization process while maintaining the security needed to meet regulatory responsibilities.

Optimization of Quality Management Processes

The solution chosen to optimize quality management processes was SoftExpert EQM, a comprehensive platform for managing documents, non-conformities and incidents, organizational changes, audits, risks, quality inspections, supplier management, employee competencies and training, customer complaints, corrective and preventive actions, performance indicators, and other essential processes for effective quality management systems.

To support accelerated growth and minimize error margins, Zepol chose to operate its system on a fully cloud-based infrastructure powered by AWS. Amazon Security Hub and Amazon Inspector provided robust tools for vulnerability management and compliance checks, while Orca Security offered a cloud-native approach to identifying and addressing compliance issues across various workloads. AWS S3 was utilized for object storage, ensuring exceptional durability and versioning capabilities, while Elastic Search Service enabled efficient indexing and full-text search functionality. Additionally, data encryption and key management were handled through AWS Key Management Service (KMS), ensuring secure data handling both at rest and in transit.

The main differentiator for selecting SoftExpert, as pointed out by the CEO of Laboratorios Zepol S.A., María Alejandra López Yglesias, was the platform's ability to manage processes in a user-friendly and reliable way, as well as its ease in fulfilling both national and international regulatory responsibilities.

Currently, all company departments use the solution to track documents on the platform, as the entire process of document creation, review, approval, storage, and cancellation is done in the tool in an easy and secure manner, maintaining compliance, history, and traceability of information. Records and resolutions of non-conformities and incidents are centralized in one place, and paperwork has been replaced by electronic forms and checklists. Moreover, quality management processes now require 70% less time, significantly improving efficiency and allowing teams to focus on continuous improvement and innovation.

Compliance with International Standards

After the platform implementation, gains were noticed in response times, control points, document management, process efficiency, and data accessibility. The solution supports the organization in maintaining certifications such as ISO 9001, ISO 14001, Esencial Costa Rica, and FDA-registered products (Food and Drug Administration), the agency that controls all American products and imports to be sold in the United States. In fact, few companies in Costa Rica have the license to sell pharmaceutical products in the U.S. Moreover, the company successfully achieved 100% compliance with both ISO and FDA standards.

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