“SoftExpert Suite, through its various modules, offers a comprehensive response to any need or process—whether related to production, management, operations, or support—ensuring full compliance with multiple regulatory requirements. In short, the solution provided a simple, organized, and efficient way to manage our integrated management system and document control.”

Frilabo increases profitability by 30% and ensures compliance with international standards by adopting SoftExpert technology

In an increasingly competitive global market, subject to ever-tightening regulatory demands, excellence in quality management has shifted from being a differentiator to a strategic imperative. According to McKinsey, companies that implement robust quality management practices can reduce their operational costs by up to 20%.

This movement is driven by the pursuit of greater efficiency, risk and cost reduction, and the need for faster, data-driven decisions. It was within this context that Frilabo sought a solid solution to manage its processes, reaffirming its commitment to the highest quality standards and delivering value to its customers.

➡️ Starting point: the search for a solid Quality Management System

Frilabo, recognized for its operations in the laboratory sector, was already ISO 9001 certified and had a document management system in place. However, with the approval of a qualification project (PT2020) and the consequent increase in quality system requirements, the existing solution proved insufficient to keep up with the new demands and growing complexity of operations.

It became essential to find a platform that not only met immediate needs but also offered scalability and flexibility for the future.

🎯 The challenge: implementing a comprehensive solution in a complex environment

Transitioning to a new quality management system was no simple task. Frilabo needed a powerful solution that could integrate essential areas such as competence and training management, document control, risk management, processes, indicators, and assets.

Moreover, implementation required dedication and meticulous configuration to ensure the software reflected the company's specific internal processes and workflows. With so many features involved, the challenge also included a continuous learning and optimization process.

🧭The strategic shift: choosing SoftExpert

After a thorough market analysis, SoftExpert stood out as the company offering the most complete solution, aligned with Frilabo’s requirements.

While other options presented gaps in crucial aspects for regulatory compliance — especially the stringent ISO 13485 — SoftExpert Suite provided a comprehensive set of modules capable of covering all critical areas.

The ability to manage everything from team training to assets and risk control in an integrated manner was decisive in the choice.

📊Results that speak for themselves: optimization, profitability, and enhanced control

The implementation of SoftExpert’s solution marked a true turning point for Frilabo. Manual, time-consuming, and error-prone processes were transformed into automated, structured workflows.

This optimization resulted in significant time savings and a notable increase in profitability of around 30%.

Process control became more effective, enabling more rigorous, proactive quality management based on reliable data.

Previously, nonconformity and complaint processes were managed manually using spreadsheets, emails, paper forms, etc. This often led to rework, errors, delays, and a lack of traceability.

With SoftExpert Suite automation, these processes are now executed automatically, reducing completion time and providing benefits such as faster approvals, standardization, full traceability, and better deadline control.

💡 The impact of SoftExpert on Frilabo's daily operations

The complete digitalization of document management enabled centralized and secure control of all documentation. Competence and training management also improved, with all training records monitored directly within the system.

• The area with the greatest impact was the laboratory and quality control. All measurement and monitoring equipment and instruments are now controlled, with calibration plans defined and monitored at set frequencies to collect readings, errors, and instrument uncertainties. Verification reports and calibration certificates are also controlled and readily available, along with the full history of events associated with each instrument.

• The quality control process has been optimized with defined families of culture media and their control characteristics, along with the specifications that must be met according to process tolerances. After quality control, a fully customized certificate of conformity is generated in compliance with regulatory requirements.

• Additionally, automating critical processes such as change control, nonconformity management, equipment calibration, and staff training has brought more transparency and agility to decision-making.

• With this robust structure, Frilabo has achieved clear gains in operational efficiency and reinforced control over essential activities.

Mafalda Regado, Technical Manager at Frilabo’s Media Laboratory, underscores the solution's importance:

“As the Technical Manager of Frilabo’s Media Laboratory, I’m a strong advocate of this quality platform, which allows us to maintain excellent process control with rigor.”