Good documentation practice and Computer Systems Validation
Best practices – we support you during introduction and implementation
Is your business subject to FDA/Swissmedic policies or to ISO 9001/13485 or similar standards? We help you define the relevant processes and SOPs (standard operating procedures) or validate the involved computer systems using CSV (computer system validation).
Thanks to our experience with the relevant regulations in the life science sector we can help you define work instructions and create and/or execute test scripts to ensure conformity.
In addition we always guarantee the desired degree of discretion in order to safeguard your data and business interests.
We’d be happy to consult with you regarding the best possible implementation and help you define the required interfaces.