Client Story

ABOUT LABORATORIOS QUÍMICA LUAR

Laboratorios Química Luar began operating in Córdoba in the 1970s with one aim: contributing to patients’ quality of life. The company develops, manufactures, and commercialises pharmaceutical products under the slogan “Innovation and development at the service of your life.”

It keeps permanent links with research institutions including CEPROCOR, the National University of Córdoba, and CONICET. Its products are distributed in Argentina and exported to the United States, Brazil, Chile, Uruguay, Venezuela, Panama, Ecuador, and Colombia, with the corresponding manufacturing and distribution authorisations from ANMAT, Argentina’s health authority.

Reaching that standard of quality depends on managing every process involved in producing, selling, and distributing its products.

A RECOMMENDATION FROM EXPERIENCE

Why Quality turned to LOYAL to reduce time spent on document control

We spoke by video call with Lisette Marile Flores, Quality Assurance Analyst, who led the implementation of the new document management system. Lisette already knew LOYAL: she had used it as an end user at Fresenius Kabi and Biofarma. At Química Luar, she is the system administrator.

The Quality team had begun evaluating document management software because certain tasks took too long. In April 2021, Lisette contacted LOYAL through our website.

“The proposal to implement LOYAL came from the need to reduce the time spent managing and controlling documentation. I knew from my experience that all of this could be solved with LOYAL, so I suggested it as a first option.” — Lisette Marile Flores

Química Luar wanted a system that would make management, communication, and collaboration easier across every area involved. After a meeting with a LOYAL sales representative and a product demo, the company chose to implement LOYAL DMS to manage its documentation more efficiently and securely.

IMPLEMENTING REMOTELY

A virtual rollout, with documentation loaded in a few months

Because of the pandemic, the implementation was carried out virtually. LOYAL’s consultants and the Química Luar team worked together, and within a few months the documentation was loaded into the system.

“The implementation and coaching went very well. The consultant, Cesar, is a great trainer. He was excellent in every meeting we had, and I am more than satisfied with his services. I even had his WhatsApp to send him any queries that might arise.” — Lisette Marile Flores

STANDARDISING DOCUMENT CODING

One coding scheme, one unique code per specification

Química Luar also needed to standardise how its documents were coded. LOYAL’s consultant proposed modifying the coding scheme to unify the codes and improve product traceability. Adopted alongside the new tool, the change gave each specification a unique identification code, making searches simpler and faster.

“Having standardised the coding of the documents makes our tasks much simpler. When it comes to searching, it is much more efficient to have everything under the same coding and not divided into different parts as we had before.” — Lisette Marile Flores

The tool also reduced the time needed to complete tasks and cut paper use.

“Excessive paper consumption is not only bad for the environment, but also for the company’s budget.” — Lisette Marile Flores

SUPPORTING A REGULATED ENVIRONMENT

Working towards validation to meet ANMAT requirements

As pharmaceutical quality standards rise, ANMAT requires validated software so that information from each phase of controlled processes is attributable, current, and accurate. The goal of validation is to generate electronic records that guarantee the transparency and suitability of drug manufacturing, in order to safeguard patients’ health.

“Software validation is an ANMAT requirement that we have to comply with. We are working together with the consultant to have the LOYAL system validated, as it is of utmost importance to have standardised all document creation and distribution, especially for our type of industry.” — Lisette Marile Flores

ADAPTING TO CHANGE

From paper to digital, with the team on board

Despite the pandemic, Lisette reports no problems using LOYAL: training and day-to-day tasks went ahead smoothly. Staff adapted well and came to see how the system speeds up their work. Moving from paper to digital is a big change that takes commitment from everyone involved.

Today, Química Luar continues to promote research and development of innovative products, responding to the medical community’s concerns about complex and underserved pathologies. We thank the team for trusting LOYAL and for letting us accompany them in this process of continuous improvement.

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