Manual processes and Regulations

The pharmaceutical sector is exceptionally unique given its high level of regulation, posing a significant challenge in terms of document management, compliance, and organization. To maintain the quality and safety required by this sector and hold a competitive advantage, there is no other option than making technology a protagonist. Aware of this reality, Química Sintética - Chemo, a leading company in the pharmaceutical industry with more than 50 years of experience, took a significant step towards digital transformation. It recognizes the challenges associated with cultural change and processes but is firmly convinced of the importance of not remaining in the past and taking advantage of the opportunities that technology can offer the business. Carlos Heredia Benito, Continuous improvement coordinator at Chemo, says that the company began researching technologies that could help in this automation journey. This became necessary as all manufacturing guides were recorded on paper forms, which took excessive time to manage, without adding value.

We were looking for a solution that adapted quickly and intuitively to our needs, ensuring the best cost-effective outcomes.

Among the criteria set for choosing the solution were business process modeling, automation of electronic forms, monitoring of ongoing processes, analysis and stratification of results, flow review and approval control, integration with other technologies, and maintaining the necessary safety requirements to comply with regulations such as the FDA (Food and Drug Administration), the body that controls all American and imported products sold in the United States.

Once the criteria were established, we went to the market and, after analyzing several options, the SoftExpert platform was the one that best suited our needs, points out Carlos

Transparency and visibility

The technology that best met the regulatory requirements and user experience on the production line was the SoftExpert software used for managing and recording business processes. Initially, it was used by all operators and technicians in the Production and Quality areas for the processes and controls required by EBR. Later, features were included, and flows were designed for other areas. It is currently used by most departments. Thanks to this solution, a multitude of processes have been automated, such as manufacturing practices, warehouse material management, quality reviews, maintenance orders, and R&D databases. Currently, with SoftExpert it is possible to map processes, subprocesses, inputs and outputs, identify risks and process indicators, model workflows, and create electronic forms using an intuitive interface. Additionally, it easily integrates with other systems and external data sources. Users can perform activities using mobile devices and monitor execution in real time through custom dashboards.

Efficiency and productivity benefits

Now, forms containing manufacturing instructions are developed and managed on the SoftExpert Suite platform. This guarantees the use of technical documents that are always up to date, which significantly reduces the use of paper, the time spent recording forms and errors. To give you an idea of the benefits, the activity of reviewing production records, which used to take an average of 5 days to complete, is now performed in less than a day. Also, the process of capturing and analyzing data, which used to take days, is now done in just a few minutes with just a few clicks.

The platform offers in-depth views of the business through dashboards and control panels, allowing us to access data anytime, anywhere, he states.

Among the results achieved, the coordinator also highlights: flexibility in managing records, work instructions, standards, procedures, added to full control of production processes and complete real-time data analysis of production processes in a simple and agile way. Also, real-time data analysis assists in decision making and provides autonomy to model processes internally. Moreover, the solution meets the requirements and validation processes of FDA 21 CFR Part 11, through resources for managing documents, records, reviews, access control, audit monitoring, indicators, processes, among other items. This increases organizational efficiency. The solution integrates users, teams, and departments through standardized processes, providing greater visibility to managers.

Reduced time and effort

With SoftExpert EBR, in addition to reducing management and review time by almost 80%, we ensure that process parameters comply with the established limits and the correct completion of guides, with information being provided by the different departments in real time.

Return on investment (ROI) for Química Sintética – Chemo in this project

Document publication and review control

Quality and design-related documents are securely stored and subject to strict review control. Only authors are allowed to make edits, which means experts and leaders are systematically assigned to review and approve changes. During an audit, the team can access any revisions thanks to the traceability of historical records. This approach simplifies the audit process and minimizes follow-up actions required to address open questions and process findings.

Multiple reporting dashboards by location and company

Process owners and managers have improved multiple dashboards and reports, adapting them to user needs. This approach encourages adoption of the new solution and adds value to all company stakeholders.

Gestion de la Qualité – QMS