IBMP cuts audit preparation time by 40% with SoftExpert Suite

An all-in-one platform strengthens quality, traceability, and the security of critical processes at one of Brazil's key public health institutions

An institution with a mission to protect lives

Based in Curitiba, Brazil, the Paraná Institute of Molecular Biology (IBMP) was established through a partnership between the Government of Paraná and Fiocruz. The institute plays a critical role in developing and manufacturing diagnostic products and solutions that help protect the health of millions of Brazilians.

With a strong focus on biotechnology, innovation, and social impact, IBMP gained international visibility during the COVID-19 pandemic and continues to play an important role in addressing neglected and rare diseases. Its portfolio includes molecular and rapid tests for COVID-19, Zika, dengue, chikungunya, yellow fever, leprosy, malaria, and Chagas disease, all certified by Brazil's health regulatory authority, Anvisa.

Behind every reliable diagnostic, however, is a complex network of critical processes that must operate with precision, traceability, and the highest standards of safety.

That was where IBMP faced some of its key challenges.

Before SoftExpert: fragmented operations and information risks

Before implementing SoftExpert Suite, IBMP faced challenges common to highly regulated environments:

• Information spread across multiple systems and files
• Challenges in maintaining regulatory compliance
• Limited visibility into internal workflows
• Decentralized management of assets and calibrations
• Rework and operational risks
• Delays in audit preparation

These challenges did more than consume time. They directly affected the institute's ability to innovate, scale operations, and respond quickly to public health demands.

IBMP needed a platform capable of bringing its processes together, increasing confidence in its operations, and reducing risk. That solution came with SoftExpert Suite.

Why IBMP chose SoftExpert

Although the decision involved multiple areas of the organization, several factors stood out as key to the choice:

• End-to-end integration of documents, processes, and assets
• Support for Brazilian and international standards and regulations
• Flexibility and scalability to support the institute's growth
• Specialized expertise and support throughout and after implementation
• A single, centralized, and reliable platform for the organization's operations

Together, these capabilities demonstrated that SoftExpert Suite could provide more than the required functionality: it could serve as the foundation for a more modern, efficient, and secure approach to process management.

Where SoftExpert Suite makes a difference today

SoftExpert Suite is now used across IBMP, supporting a wide range of activities — from everyday tasks to highly critical processes.

With access groups structured around departments and responsibilities, the digital environment provides greater organization, security, and consistency while enabling broad, centralized, and integrated use across the organization.

This journey begins as soon as a new employee joins the organization. HR initiates the New Employee Access process, developed and customized by SoftExpert, providing a structured way to track the access requirements for each employee and replacing the previous email-based request process.

From their first days at IBMP, employees also interact with SoftExpert Suite to complete required training and review mandatory documents related to their roles.

The Document component is another example of how the platform is used across the organization. IBMP maintains a comprehensive category structure covering procedures, work instructions, technical documents, and informational materials. Each department can participate in creating, reviewing, and updating its content, reducing reliance on physical documents while centralizing the control, availability, and traceability of institutional information.

In critical areas, this integration becomes even more valuable. The Quality Assurance team uses customized workflows for activities such as Change Control Management and Nonconformity Management, developed by SoftExpert to reflect IBMP's specific requirements. Activities that previously relied on decentralized controls can now be managed through structured workflows, records, and follow-up within the same system.

Within the Technology Development area, researchers use the Document component to record and maintain information related to their activities. The Product Development process enables teams to track the different stages of development, giving IBMP a centralized view not only of records, but of the entire development workflow.

Engineering and Maintenance teams use the Asset component to manage equipment and institutional assets, while the Maintenance component supports preventive, scheduled, and corrective maintenance activities. Technicians also use tablets to complete and track checklists directly in the field, bringing process control into day-to-day operations.

HR also uses the Survey component as a centralized platform for organizational surveys, including employee engagement surveys, satisfaction surveys, and elections for the Internal Accident Prevention Committee (CIPA) and Emergency Response Team, among other initiatives. This allows different information-gathering activities to be managed within a single platform rather than relying on separate external tools for each purpose.

In addition, departments have the autonomy to create their own portals, dashboards, and performance indicators through the Analytics component. This enables teams to turn process data into actionable information for monitoring performance and supporting decision-making. SoftExpert also provides ongoing support to help teams evolve and maintain these solutions.

“SoftExpert Suite has made our internal workflows more agile, helped us meet audit requirements, enabled us to scale process management, and strengthened IBMP's competitiveness by reducing risks and increasing operational reliability.”

Jhonatan da Silva, Systems Analyst, IBMP

Results that strengthen quality and confidence

✔ Greater operational efficiency

Tasks that were previously manual, such as locating documents, gathering evidence, consolidating spreadsheets, retrieving historical records, and requesting information from different departments, are now standardized and automated, reducing errors and providing greater traceability.

• 40% less time spent preparing for audits

What previously took approximately 40 hours can now be completed in around 24 hours.

✔ Higher team productivity

With documents, processes, and assets centralized, teams can access the information they need faster and complete tasks more efficiently.

• More than 95% less time spent locating documents

Document searches that previously took around 20 minutes can now be completed in just a few seconds.

• 50% increase in team productivity

Centralized information and automated workflows reduce manual activities and administrative effort, allowing teams to focus on higher-value work.

• 6,000+ assets managed through SoftExpert Suite

Centralized information, complete asset history, and maintenance tracking provide greater visibility and control over IBMP's equipment and assets.

✔ Stronger compliance

• Faster audits, readily available evidence, and complete activity histories help reduce regulatory risk.

   

With SoftExpert Suite, IBMP has built a more connected, traceable, and efficient approach to managing its operations, strengthening the foundation for quality, compliance, and continuous improvement in an industry where there is no room for error.