Certificates and validations.
Besides the necessary documentation for use, operation and maintenance manuals are delivered with the machine, customers can ask for a validation protocol / qualification protocol, written according to the GMP y GAMP 5 guidelines, created and used by Pharmaceutical sector.
This documentation certifies with the highest certainty that the equipment has been designed, built and operates according to the predefined specifications and corresponds with the standards required. The validation / qualification pack is composed by protocols FS, DS and IQ/OQ which are written and executed by our experienced team of technicians.
FS documents the specifications corresponding to design. DQ validates the design and IQ/OQ documents and controls the installation and operatively of the machine.
Dara Pharmaceutical has always given high attention to the quality, safety of the data and care of the Instruments used. This commitment is motivated by our company’s competence and reliability.