Belfar boosts document efficiency and security with SoftExpert: 60% faster SOP approvals

The pharmaceutical market continues to grow, generating over $1.4 trillion globally. To stand out in this highly competitive environment, companies in the sector must ensure fast, secure, and compliant processes that meet increasingly strict regulatory standards.

With 50 years of experience, Belfar has established itself as a respected pharmaceutical company, specializing in the production of specific medications, herbal medicines, similar drugs, and generics. The company operates multiple facilities and employs nearly 700 people, with a product portfolio that continues to expand in line with market demands.

However, keeping up with this growth brought major challenges:

● Increasingly strict regulatory requirements
● Difficulty locating and tracking documents
● Slow, manual, and bureaucratic processes

Quality management had become a bottleneck, demanding a digital transformation to ensure compliance, security, and agility across internal operations.

Greater efficiency and enhanced quality with SoftExpert Document

To address the challenges of document management, Belfar adopted SoftExpert Document, a solution designed to streamline processes and ensure regulatory compliance. The digitalization brought transparency and traceability, while significantly reducing the time spent managing documents. The implementation was carried out by TNX, a trusted SoftExpert partner.

Today, the system supports all of the company’s technical areas, including Quality Assurance, Validation, Product Development, Quality Control, Regulatory Affairs, and Production. This ensures that every department has access to the most up-to-date versions of critical documents.

In the pharmaceutical industry, process standardization and regulatory compliance are essential to ensure the safety and quality of operations. Standard Operating Procedures (SOPs) are a key tool in this context. They provide detailed instructions for carrying out specific tasks, ensuring that all employees follow Good Manufacturing Practices (GMP) and other regulatory requirements, promoting consistency and safety throughout the production process.

Kelen Araújo da Torre Siqueira, Quality Assurance and Validation Coordinator, highlights that the implementation of SoftExpert Document has been crucial for optimizing SOP management, enabling more efficient control over the review, creation, and distribution of documents. It also facilitates traceability and ensures that all operational areas use the most current versions of these documents.

Moreover, in the pharmaceutical industry, SOPs play a vital role in reducing risks such as dosing errors and cross-contamination, both of which can compromise patient safety.

“The solution ensures that all documents are always up-to-date and easily accessible, making version control simpler and ensuring regulatory compliance. Through digitalization, we’ve been able to streamline the review, creation, and approval of SOPs—improving not only speed but also the quality and safety of our entire production process,” says Kelen.

Accelerating SOP review with speed and compliance

The positive impact was evident within the first few months of using SoftExpert Suite:

✅ 60% reduction in Standard Operating Procedure (SOP) approval time

✅ Automated generation of controlled copies and revisions

✅ More traceability, speed, and security in document management

Before implementation, the company relied on various manual tools to manage version control and used different formats for tracking document copies. Now, with process automation in place, those obstacles have been eliminated—enabling more organized and efficient work.

Expansion and new implementations

The adoption of SoftExpert Document marked the beginning of Belfar’s digital transformation journey. Building on this success, the company plans to expand the use of the system to other areas, and implement SoftExpert Training.

By leveraging technology, Belfar reaffirms its commitment to providing safe and effective medications, while continuing to prioritize innovation and quality in pharmaceutical care.

Benvenuti a SoftExpert EHSM

Monitoraggio e tracciamento degli incidenti

Automatizzare e semplificare il processo di gestione degli incidenti

Eseguire gli audit e mantenere un registro completo delle prove.

Registrare e documentare le non conformità in modo efficiente

Tracciare e gestire i follow-up del trattamento del rischio

Attuare e controllare le azioni correttive e preventive (CAPA).