21 CFR Part 11 compliance basics include: Secure, well-managed streams of information with access control and retrieval. Properly controlled documents with a high level of integrity and protection. Traceability of record histories and iterations.

21 CFR Part 11 is the FDA's regulation for electronic documentation and electronic signatures. It outlines the administration of electronic records in a medical device company's quality management system and gives guidance for industry best practices.

What Are the 5 Types of Signatures? Written or Wet Signature. Written signatures, also known as wet signatures, are one of the most traditional and commonly used types of signatures. ... Electronic Signature or E-signature. ... Digital Signature. ... Symbols and Marks. ... Clickwrap Signature.

Signers can create a secure and verifiable signature on any device, and use the signatures to digitally embed them to a specific location on the contract documents. Electronic signatures can be seamlessly integrated with Salesforce workflows, allowing you to edit, sign, send, and track documents in seconds.

Three of these main categories are a wet signature, electronic signature and digital signature solutions. Let us explore these three categories more and understand the impact these three types of signatures have on business processes.

What is 21 CFR Part 11? CFR stands for “Code of Federal Regulation.” 21 CFR Part 11, in particular, details the criteria under which electronic records and signatures are considered to be trustworthy and equivalent to paper records.

21 CFR Part 11 applies to clinical trial sponsors, including pharmaceutical and medical device companies, who are conducting FDA-regulated research. It also applies to Clinical Research Organizations (CROs) and research sites.