28.2.2017. OperaOpus has passed the validation of the computer system
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 EU Annex 11 for Computerized Systems