Apsen Pharmaceutical mitigates regulatory risks with SoftExpert Suite technology

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For many companies, facing regulatory audits can feel like a trial by fire. However, for those that have made compliance a core part of their strategy, each inspection becomes an opportunity to reinforce their market position. Imagine the impact of a successful audit: it not only ensures operational continuity but also fosters unshakable trust among consumers, elevating the company to a level of competitive distinction. It was with this vision that Apsen chose SoftExpert to digitally transform its business.

Previously, the company faced challenges with its document management system and even received inquiries from Anvisa regarding the system’s validation and weaknesses. Giselle Gataz, Technology Products Coordinator, explains: “The goal of a system is to make the user’s life easier, not the other way around. We don’t want the user to work for the system; instead, the system should add value and support the team.”

Driven by the need for improvement, Apsen explored alternatives. After hearing positive feedback from employees about SoftExpert, the decision was unanimous. Giselle emphasizes the software's robustness, flexibility, and ease of use, which allow it to meet the sector's stringent requirements, including those of Anvisa.

"In the pharmaceutical sector, the difference between medicine and poison is the dose. We deal with high-risk issues, so having a platform that ensures agility and security in our processes is essential. SoftExpert Suite has provided us with exactly that."

Transformation in Quality processes ❇️

At Apsen, the Quality area leads the use of the platform, managing essential processes such as procedures, training, deviations, incidents and change controls, always with well-founded corrective actions. Currently, there are 767 procedures and 1,300 forms managed on the platform, reinforcing the importance of the system in the continuous improvement of operations.

The traceability of information is one of the greatest advantages of SoftExpert Suite pointed out by the Quality Assurance Coordinator at Apsen, Saori Takano Kajihara. She highlights the ease of accessing critical data with just one click, which facilitates the monitoring of incidents and deviations. The platform provides real-time flowcharts, detailing each step and allowing for agile and efficient management.

"The main benefits include version control and document updates, process automation and continuous training monitoring, resulting in greater organization and agility in daily activities. The system centralizes materials and records, facilitates access to documents and training, and contributes to compliance with regulatory standards in a simplified and transparent manner", emphasizes Saori.

Strict compliance and efficiency in audits 🔎

Every change or implementation process at Apsen undergoes thorough validation to ensure compliance and traceability. Giselle explains, “The audit module streamlines the recording and export of information, providing transparent proof of all actions taken, including details on responsible individuals, modified data, and an accurate timeline.”

The platform also allows for strict customization of user access based on sector-specific roles, ensuring that only authorized personnel can approve or modify change controls, thus safeguarding the integrity of the process.

Efficiency and transparency in training 💡

SoftExpert's tool has transformed Apsen's corporate training by shifting from in-person sessions to online courses, addressing challenges like limited physical space and the complexity of evaluating effectiveness. Online training now offers greater flexibility and allows for efficient tracking of employee performance.

Since implementing SoftExpert Suite in 2019, Apsen has reached a major milestone, delivering over 20,000 online training courses. This achievement underscores the comprehensiveness and effectiveness of the company's training programs.

Traceability is a standout feature, with each module linked to tests requiring full accuracy to pass. If not, additional training is provided to ensure content is properly absorbed. The platform's ability to identify content gaps leads to continuous improvements. Giselle emphasizes that the platform’s ease of data access and report generation is a significant advantage.

Before automation, training was manually tracked, consuming time and resources. Now, automated reports provide an up-to-date status for each employee, eliminating the need for manual checks and saving time and resources. The platform also offers complete transparency, enabling managers to monitor team performance through detailed reports and indicators, making individual assessments simpler.

The importance of building strong customer relationships 🙏🏽

Giselle highlights the special relationship with SoftExpert: “With SoftExpert, it’s different. It’s like a true partnership, a bond of interdependence. Our needs and challenges often inspire improvements that enhance the platform, benefiting both sides and strengthening our trust in working together.”

Unlocking the full potential of the platform🚀

Apsen's IT team is committed to unlocking the platform's full potential across all departments, revealing its features and encouraging teams to make the most of its capabilities. “I always say we need to explore the tool thoroughly to identify underused resources, so we can continuously improve our processes,” says Giselle.

The company is now in the final stages of integrating risk management, competency, and indicator modules, while also exploring gamification to engage employees in a dynamic and effective way.

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Pharmacovigilance

Related terms

Biosimilars

Active Pharmaceutical Ingredient (API)

Case Report Form (CRF)

Complete Compliance and Governance