DocuSign and 21CFRPart11
Valentia Analytical has implemented DocuSign with an upgraded 21CFR11 module. DocuSign is a secure cloud-based application for the application of electronic signatures improved efficiency in obtaining approval of documents. This enables remote approvals which is particularly important in light of maintaining social distance standards related to COVID-19. The 21CFR11 module is a significant added cost. However, it was an investment to ensure compliance to 21CFRPart11. This is an important regulation governing electronic signatures and electronic records. Risk assessments, user requirements, Installation qualification, operational qualification, and performance qualification of DocuSign with the added 21CFR11 module have been initiated to validate compliance of its implementation into the systems at Valentia Analytical.