"With the support of TNX, we implemented SoftExpert Suite quickly and efficiently, streamlining document management and ensuring greater traceability and data integrity. This digital transformation has strengthened our compliance and operational efficiency, both essential in such a highly regulated industry like pharmaceuticals. Together with SoftExpert, Belfar is ready to grow with confidence and excellence."
Kelen Araújo da Torre Siqueira - Quality Assurance and Validation Coordinator
60% faster approval of Standard Operating Procedures (SOPs)
SoftExpert Document has been crucial in optimizing the management of SOPs, ensuring more efficient control over their review, creation, and distribution
All technical areas connected through a unified, efficient system
The solution fully supports all of the company’s technical areas, including Quality Assurance, Validation, Product Development, Quality Control, Regulatory Affairs, and Production
Improved traceability, faster access, and enhanced document security
Document management ensures not only faster processes, but also the quality and security of the entire production workflow
Belfar
With 50 years of experience, Belfar is a well-established pharmaceutical company specializing in specialty pharmaceuticals, herbal medicines, and generics. The company operates multiple facilities and has a team of approximately 700 employees. Its product portfolio continues to grow, aligned with evolving market demands and industry trends.
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.
