Hardware, software and the validation required for those systems can make for a costly capital investment in licenses, technology, time and salaries. The typical enterprise system can take months to deploy – from project planning and requirements gathering, through software installation and validation, to the point where the system is ready to be used and maintained. Companies outside of the Life Sciences industry have used the cloud to mitigate this risk, so they can begin to see a return on investment more quickly. Unfortunately, companies for which regulatory compliance is a condition of doing business haven’t yet been able to realize that return on investment due to the lack of compliance controls available in the cloud.
Validated Cloud is 21 CFR Part 11/820 compliant and hosted in a SAS 70 Type II Datacenter.