The 21 CFR Part 11 is
used to permit the possible use of electronic technology in pharmaceutical
industry. This rule was developed by the FDA (Food & Drug Administration), and is divided in two
main sections: Electronic Records and
Electronic Signatures. The FDA developed the 21 CFR Part 11 rule to
describe the electronic records and signatures requirements so that they are
secure.
CM-0/1200 ICH is a compact chamber designed to make test in a high
number of samples at the same time, but reducing the space that the climatic
chamber occupy in the laboratory. This chamber is configured with the new
controller/data recorder unit in order to comply the pharmaceutical stability
test with the best accuracy and stability. According ICH guidelines and FDA.
If you want more information, please contact us in comercial@dycometal.com or in our website: www.dycometal.com
DYCOMETAL, company with over 25 years of experience in the
development of Chambers for environmental testing simulation, offers its
customers CLIMATIC
CHAMBERS to do these tests.
