Success case – Catarinense
History: For over 75 years, we have been a fount of health!
Driven by the purpose of “Being a fount of health”, Catarinense Pharma operates in the pharmaceutical area in the development and sale of medicines, herbal medicines and food supplements, all designed to contribute to the well-being and quality of life of Brazilians.
There are more than 300 products, including herbal medicines from different therapeutic classes and a wide range of food supplements. Among the highlights is Melagrião, the best-selling herbal syrup in Brazil, the digestive Figatil, and Omega 3 supplements, Magnesium Chloride, Tryptophan and Coenzyme Q10, leaders in the national market. In addition, Catarinense Pharma is the third largest multivitamin manufacturer in Brazil.
They are headquartered in Joinville/SC, and the pharmaceutical industry has been using the company’s experience and innovation, as strong allies in the strategy of expanding its product line, following maximum and indisputable quality criteria in the production process and in the origin of raw material. Added to this is the legacy of a family structure, which is based on the values of honesty and trust, translating Catarinense Pharma as “being a fount of health”.
Challenge
Expansion of the company with the opening of a new unit in Aparecida de Goiânia for packaging and distribution.
This choice of location was strategic, as the city is in the Center-West region and facilitates distribution throughout all of Brazil.
One of the many tasks that the project demanded was the challenge to expand the internally developed ERP system and make the operation of this new unit feasible.
Solution
ERP expansion is supported by computer system validation, a regulatory obligation from ANVISA, the Brazilian Health Regulatory Agency. New features were developed to meet new operational logistics and the local inspection, to issue a License to Operate. For this reason, Catarinense Pharma had the support of FIVE Validation in the preparation and joint discussions for the Functional Risk Assessment and the audit of test executions.
Benefit
the complete validation of the new version of the system was carried out in record time – in about just 5 weeks - with the help of the GO!FIVE™ tool. This tool, VLMS (Validation Lifecycle Management Software) developed by FIVE Validation, contains a library of templates composed of requirement, risk scenario and test items, that helped and accelerated the validation.
“The tool includes the library that facilitated validation, streamlining the process. Some risks would not have been mapped if the library had not brung such scenarios. These new items made the work more robust.” Kamila Mondo, Quality Assurance Analyst.
“The library helped a lot. FIVE's technical support, with an impartial view, helped to drive the process that brought a more established culture regarding the importance of Software Validation.” Francine Pereira, Quality Assurance Coordinator.
“Without question, technically, the library has reduced and allowed more assertive targeting. FIVE was a great partner, they were really engaged, working outside hours to assist us. It didn't seem to be only a supplier, but part of our team”, Roselene Tormem, Technical Manager.
Future plans
centralize the Distribution Center, increase the customer base and product portfolio, as is possible to increase the physical space for greater operation.
