28.2.2017. OperaOpus has passed the validation of the computer system
http://www.agmar.org/en/
As part of the implementation of the OperaOpus system in Agmar, a computer system validation project was developed that involved the following processes: procurement, storage, approval of products (medicines and medical products) for wholesale, sales and traceability. In addition to the system, extensive activities related to testing of key functionalities were provided, complete documentation was provided, and HALMED agency (Agency for Medicinal Products and Medical Products) confirmed with the inspection that our system successfully passed validation!
As part of the project, the following directives and guides were consulted and implemented:
· FDA i FU direktive:
o 21 CFR Part 11, Electronic Records and Signatures
o
OperaOpus/KončarERP in the company Končar–Electrical Industry Inc, Zagreb&Končar–Renewable Sources I
http://www.koncar.hr/en/
02/01/2017. As part of the partnership with Končar - Energy and Transport Engineering Ltd., on the implementation of our system in Končar group companies, we have contracted implementation of our system in companies Končar - Electrical Industry Inc.(KDD) and Končar - Renewable sources Inc. (KOI). KDD is a umbrella company operating on the company's business in Končar Group through the General Assembly and the Supervisory Board. KOI is a company that invests and manages projects in the field of renewable energy sources.