“We chose SoftExpert because it supports the information volume of our quality system and primarily because it is designed for the application of Good Manufacturing Practices, translated into manuals, procedures and instructions. It fits within our strategy of using a logical tool that allows us to minimize and eliminate the use of physical documents, as well as make the work of each sector and tracking control more efficient.”

Rosa Guillermo - Technical Director and Quality Assurance Manager

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Optimized Document Management

Efficient document control for approvals, distributions, revisions, and cancellations, with the ability to associate a large volume of documents in various formats

Good Practices Automation

Support for the application of Good Manufacturing Practices in manuals and procedures, making sectoral work and tracking control more efficient

Greater Operational Efficiency

Optimization of production, distribution, and real-time information access, with the elimination of physical documents and reduction of rework

Farmindustria has accumulated extensive experience during the nearly 50 years that it has been dedicated to producing pharmaceutical products within the highest quality standards. The laboratory is the industrial portion of the Drokasa Corporation. It manufactures and sells pharmaceutical products, perfumery and bath items at its ample and modern plant. It is the second largest pharmaceutical laboratory in the Peruvian market, with a 6.75% share in the total number of units sold.

Challenge

Farmindustria, one of Peru’s main pharmaceutical laboratories, faced the need to improve the management of its quality standards based on national and international ISO 9001 norms and Good Manufacturing Practices. The company required a tool that could manage the large volume of information within its quality system and minimize the use of physical documents, ensuring efficient tracking control in each sector.

The Solution

Farmindustria chose SoftExpert Document, SoftExpert Action Plan, and SoftExpert Audit solutions to achieve its objectives. The SoftExpert Document solution was implemented to systematize and electronically control documents within the Quality and Good Manufacturing Practices system. After the review, identification, and evaluation of key processes that demand precise control during their development, Farmindustria decided to install SoftExpert Action Plan, designed to standardize and order processes such as corrective actions, change control, complaints, and occupational health and safety. Subsequently, SoftExpert Audit would be installed to further enhance management. The implemented technology aimed to immediately improve manufacturing processes and quality management, ensuring compliance and information security.

The Results

The implementation of SoftExpert solutions brought immediate benefits to Farmindustria, as highlighted by Rosa Guillermo, Technical Director and Quality Assurance Manager. Documents became easily available and locatable, ensuring the company constantly has updated versions readily accessible. The solution boosted team efficiency and precision by providing centralized access to information, helped ensure compliance with standards and regulations, and optimized business performance. The elimination of outdated document copies and the reduction of printouts and paper circulation needs contributed to a more efficient and sustainable operation. Users can now maintain a history of all document versions/updates, and Action Plan automation allows for creating statistics for distinct activities, analyzing, planning, executing, and verifying actions in real-time, facilitating decision-making and the development of new courses of action.

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