The Annex 11 regulation provides guidance on how to implement an electronic signature system that meets the requirements of the
The Code of Federal Regulations (CFR) is the official codification of the general and permanent rules published in the Federal
The compliance landscape for electronic records and signatures is constantly evolving. Two key sets of regulations that have shaped this landscape are
When it comes to Data Integrity, most companies will understand “why do it” but are unsure of “how to do it” most effectively.
The Indonesian National Drug and Food Control Agency or locally known as BPOM released a regulation No 8 Year 2020
In March 2020, BPOM released a revised version of Good Distribution Practices (GDP) No 6/2020, replacing the same regulation (No