In preparing this guidance, the study group was not aware of any regulations, which required written translation of quality system documentation into a specific national language. However if this should be required it is recommended that this be limited to the very top level of documents. The use of widely accepted international commercial languages should be allowed.
Related Whitepapers
-
Mastering Compliance: Leveraging Next-Gen Audit Management Solution for Regulatory SuccessIn an era marked by the intricate and ever-evolving nature of regulatory demands, the strategic…
-
Remote Audit Best PracticesThe goal of an audit is to evaluate the presented evidence and objectively determine the…
-
Layered Process Audits 101By using Layered Process Audits or LPAs, manufacturers can focus on parameters, settings, or behaviors…
