FDA 21 CFR Part 11 , the American Food and Drug Administration (FDA) specifies requirements for electronic documents, electronic signatures and handwritten signatures applied to electronic documents regarding trustworthiness, reliability, and equivalence to paper documents and handwritten signatures applied on paper. The requirements always apply, if information is created, changed, stored, transmitted or accessed electronically. If the documents generated, stored, transmitted or modified in this way serve to prove compliance with regulatory obligations, the requirements must be met. However, 21 CFR Part 11 is to be applied especially, if electronic records replace paper.
FDA 21 CFR Part 11
Our digitalization solutions primarily address document-based processes in manufacturing, production and quality management. The basis of the d.3 life sciences system is a holistic ECM/DMS system. The ECM/DMS system can be linked to your existing ERP system (e.g. SAP), thus enabling you to implement almost all document-based processes in your company.
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