Developed in the environment of medical technology, DOQ meets all basic regulatory requirements for use in pharmacy, biotechnology and medical technology (FDA 21 CFR Part 11, ISO 13485/2016, MDR). The validation support during the implementation of our software modules ensures the safe auditing of Notified Bodies and FDA. Each DOQ release is delivered again with complete validation and thus guarantees a permanently lower effort of the QM department.
DOQ can be introduced within only 3 months due to its modern interface architecture and high user acceptance. We support you with all the necessary training and documents needed for going live.
Due to the complete validation and the possibility of an electronic signature DOQ is able to realize a completely paperless production. This rules out the possibility of different data storage between the paper process and the digital process. DOQ fulfils all FDA requirements according to 21 CFR Part 11, which are demanded of quality-relevant software in manufacturing companies.