Need to automate and integrate its processes

Working in an extremely regulated sector, the pharmaceutical company identified the need to automate and integrate its processes, since many activities were manual, carried out through paper forms, with wet signatures, Excel spreadsheets and emails, which made it difficult to control actions and traceability of documents, generating bottlenecks, delays and reworking. Hypofarma's IT manager, Giulio Chiabi, recalls that it was not possible to monitor the situation of the Non-Conformity Registration (NCR), Change Control and Customer Service Occurrence Registration processes in real time and the visibility of the progress of action plans, generated from these processes, was deficient.

“Because it involved paper forms, the proper control of the documentation required great effort and traceability left something to be desired. In addition, non-compliance with deadlines of action plans was frequent because we did not have management tools with notifications of pending tasks and delays,” he says.

Transformation process by integrating its ERP

Hypofarma has taken an important step in the digital transformation process by integrating its ERP into the SoftExpert Excellence Suite, facilitating the traceability of products, optimizing service and centralizing the control of information. For Chiabi, the rigorous document control processes, the digitization of flows and the total traceability provided by SoftExpert were preponderant factors for Hypofarma to deploy the suite in its operations. He comments that the solution provides full visibility into the progress of flows and actions in progress, with online monitoring of deadlines and status.

“With the implementation of the Process, Problem and Form components, the progress of the processes and action plans began to be managed in real time. No task or action is pending execution without the knowledge of those responsible and managers,” he points out.

Currently, the areas that use the solution are: Quality Assurance, Pharmaceutical Production, Product Development, Quality Control, Analytical Development, Engineering and Maintenance, Logistics, Regulatory Affairs, HR and IT. Chiabi also reinforces how the management of critical Quality processes on a web platform is fundamental, especially in times of remote working. “The use of electronic forms, automated process flows and electronic signatures ensured data integrity and proper traceability, allowing our employees to perform their activities regardless of the physical location," he says.

Management of non-conformity registration flows

Hypofarma's IT manager, Giulio Chiabi, says that the traceability and data integrity requirements, required by regulatory standards, were met at all stages of system validation. “As such, we have full reliability that our medications are being produced within the strictest safety and efficacy criteria,” he says. Chiabi also reinforces that the implementation of the solution represented a watershed in the company's digital transformation journey and states that the new process automation initiatives will be directed primarily to the SoftExpert platform. “The integration developed with our ERP has expanded the possibilities of sharing information between the tools, making them intertwined solutions to improve our processes.”

With automation, which includes workflows, signatures and electronic forms, the company also reduced paper consumption by 30%. In addition, the processes and action plans began to be managed in real time, generating frequent notifications to those responsible for the actions and, consequently, enhancing the management of non-conformity registration flows, change control and the registration of customer occurrences.

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