“The SoftExpert Suite platform helps us daily with the management of our Quality System documents, making it easier to control activities, and providing us with greater availability to implement improvements in Quality Assurance activities.”

Tatiana de Almeida Dutra Cardozo, Quality Assurance Coordinator at BIOMM.

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Management, review, and approval of the entire documentary cycle;

Control and organization of the flow and status of information and data;

Management of work procedures and practices for the entire company;

Credibility, governance, effective management, and higher quality of documents;

Mastering tasks;

Compliance with mandatory regulatory requirements for the sector.

BIOMM was created with the mission of developing, producing, and distributing globally competitive biomedicines, with quality and accessibility, offering the best treatments to increasingly more people. Founded in 2001, as a result of a partial spin-off of a large global insulin producer, it is the first and only Brazilian company completely focused on biotechnology.

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Digital transformation 

BIOMM acquired SoftExpert's solution to solve the challenge of managing multiple documents and flows. This process was carried out using spreadsheets, which in addition to taking up employees' time, was prone to errors that could directly impact the company's operations.

Management excellence

Used by all company professionals, SoftExpert in the AWS cloud reaches BIOMM's 130 employees through the enterprise content management solution. The Quality Assurance area has all the necessary support to meet the regulatory requirements and the high compliance standards of the Pharmaceutical Quality System. Encryption and key management were supported through AWS Key Management Service (KMS), which ensured secure data.

Additionally, Amazon Security Hub and Amazon Inspector provided robust vulnerability management and compliance checks, while Orca Security offered a cloud-native approach to identifying and addressing compliance issues across workloads.

The SoftExpert platform enables collaborative editing of multiple files by users across different departments. To support this functionality, AWS S3 was utilized for secure file storage, providing advanced version control and exceptional durability to ensure data integrity. Additionally, AWS Elastic Search Service was implemented to facilitate efficient indexing and seamless full-text searches, enhancing the platform's usability and ensuring quick and accurate access to critical information.

 The SoftExpert platform allows multiple files to be edited by people from different areas. The practice increases work efficiency and optimizes the time of all professionals involved. Furthermore, the module guarantees review, approval, and management of everything necessary. With a large flow of information and the need to know their status, the platform provides agility for managing outstanding documents and making sure those responsible are performing the necessary actions. The SofExpert Suite solution, combined with the AWS cloud environment, was critical for the success of the project, enabling access to a robust, secure, and efficient technological architecture, without requiring investment in servers, databases, and operating systems, as would happen in a traditional IT architecture.

Real progress

As for the results achieved, it is possible to mention several gains: productivity, agility, time, control, quality, cost savings (hours, percentages, among others). A 40% reduction in document management costs and up to a 90% reduction in repetitive tasks were also achieved. Using the SoftExpert platform, BIOMM gained greater control over the tasks performed by employees, thus being able to manage the deadlines more assertively for each action. Regarding the next steps of the partnership, the companies point out the plan to use more SoftExpert Suite modules in order to manage other activities linked to the Pharmaceutical Quality System. The implementation and validation of this module made it possible to manage actions linked to deviations and change control.

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