Laxai

LAXAI provides state-of-the art Clinical Data Management facility located in India. The backbone of the data center is a high speed communication link with Virtual Private Network and Network Management Services. Access Control mechanisms have been incorporated at this Data Center as per 21 CFR 11 guidelines. The access controls include a combination of Physical and Logical access control. The data center has provisions for backup and restoration of data in tapes. The tapes are stored at offshore as per SOPs and BCP/ DR procedures. The infrastructure includes high-availability, secure rack mountable machines which are installed and configured as per IQ/OQ specifications provided by the manufacturer. We have the latest version of software including EDC tools, Document management tools and Digitization solutions. We ensure that COTS software we offer to our customer is in a validated state and supported by the vendor. We have stringent SOPs regarding access control and data management and our Quality Managers ensure that there are no process deviations.