Compliance solutions for health and well-being industry

Expert in Computer Systems Validation

Leader in Regulatory Affairs and Pharmacovigilance in Brazil

SIS – Safety Information Solution

Full system for Post-commercialization Product Safety. Provides features for processes quality and productivity improvement.

RAS – Regulatory Affairs Solution

RAS is the most advanced and complete solution in the Brazilian market for information and regulatory processes management.

DMS – Document Management Solution

DMS has a rich set of features for the management of documents.

Computer Systems Validation

Document process that ensures the integrity of data related to the automated industrial production.

Training Mentoring

Qualification in Computer Systems Validation and in company’s solutions.

Clients

Testimonies

"Several projects have been concluded and some are still ongoing, but we had the privilege of counting on Organex to develop them. I have Organex as a great partner to help us face daily challenges in such crucial sector as the life sciences.
Showing great professionalism and promptness, Organex professionals, whom are technically differentiated in the marketplace, are engaged in the project’s development and the results have always been exceptional.
We are counting on Organex for future projects for sure and we do not intend to leave our partnership behind."

− Jorge Felipe, IT & System Validation Manager at Medquímica (Pharmaceutical Department in Juiz de Fora – MG)

"Organex team is highly capable and ready to respond the company’s requests. We were happy to work with them in a Project and we were pleased with the results, as well as the conduction of the work."

− Nadia Hage, Technical Coordinator at Meda Pharma (Pharmaceutical Department in São Paulo – SP)

"I’ve followed several projects along with Organex, where so many managers and as the analysts are very experienced in technical issues and seem committed to the business.
I know these projects were great learning opportunities, and a great time to exchange experiences. I thank the company for the support provided, as always."

− Estevan Figliolia, is monitoring the project with about 200 automation projects at Eurofarma.

"Criogênesis is the number one company in São Paulo for umbilical cord stem cells harvest. We were subject to audit conducted by AABB (American Association of Blood Banks). It is a specific International Accreditation Program for Blood Banks, which has verified and approved of, among other parameters, the “PREMIER” Computerized System Validation documentation, a program exclusively developed by Criogênesis to support its own operations. We appreciate the work provided by Organex and our partnership that has been aiding us from interactions and guidance to develop documents and adjustments to the system according to CFR 21 part 11, national standards, to fulfill AABB requirements, and to create and manage system validation documentation."

− Dr. Luiz Cesar Espirandelli, Criogênesis CEO

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