{"id":1297,"date":"2021-07-30T11:59:35","date_gmt":"2021-07-30T06:29:35","guid":{"rendered":"https:\/\/blogrevv.revv.so\/?p=1297"},"modified":"2022-11-28T11:06:42","modified_gmt":"2022-11-28T05:36:42","slug":"revv-the-best-electronic-signature-platform-to-process-fda-documents","status":"publish","type":"post","link":"https:\/\/www.revv.so\/blog\/revv-the-best-electronic-signature-platform-to-process-fda-documents\/","title":{"rendered":"Revv | The Best Electronic Signature Platform to Process FDA Documents"},"content":{"rendered":"\n

All the efforts and pursuits of the US Food and Drug Administration are directed towards the advancements of public health nationwide. It exercises strong leadership to ensure we use good quality food and drugs.<\/p>\n\n\n\n

The FDA formulates rules & regulations, carries out inspections, grants research permissions, and whatnot to protect the quality of drugs, biologics, and medical devices. To achieve all this, the organization and others (individuals, groups, or businesses who apply for research or who own a company that comes under the FDA) have to deal with tedious paper-based documentation processes and undergo the troubles of wet signatures. This takes a lot of time, money, and patience.<\/p>\n\n\n\n

To help professionals focus on their goal rather than spending hours getting a signature on a form, most business and government entities accept and promote the use of electronic signatures today. FDA too has approved eSign usage under its regulations to lubricate the process.<\/p>\n\n\n\n

FDA & eSign share the common goal of safety<\/h2>\n\n\n\n

FDA and electronic signatures are two different fields but both work for a common objective – safety.<\/p>\n\n\n\n

Here\u2019s how –<\/p>\n\n\n\n

The Food and Drug Administration protects public health. Its sole purpose is to critically examine the efficacy and safety of various human and veterinary drugs, biological products, medical devices, etc. FDA also works with multiple industries to issue recalls and safety alerts for the nation\u2019s health protection. <\/p>\n\n\n\n

On the other hand, an electronic signature is based on a technology that guarantees the validity and legality of the signature. It protects individuals and businesses from frauds and forgeries and helps them carry out their professional work without impediments.\u00a0<\/p>\n\n\n\n

Checklist | How to ensure eSignature validity as per FDA CFR 21 Part 11?<\/h2>\n\n\n\n

Title 21 CFR Part 11 is a section of the Code of Federal Regulations of the FDA. It is responsible for establishing the regulations on electronic records and electronic signatures. More commonly known as Part 11, it sheds light on all the criteria under which electronic records and signatures are considered to be valid and at par with traditional paper records.<\/p>\n\n\n\n

Today most manufacturing companies, individual researchers, and people, in general, have made a switch from paper-based processes to an electronic model of operations. Seeing this, a new set of regulations<\/a> for electronic records and signatures have been subjected under the FDA CFR 21 Part 11.<\/p>\n\n\n\n

Here is the checklist for an electronic record\/signature to be accepted by the FDA –<\/p>\n\n\n\n

Validation: For Security<\/strong><\/h3>\n\n\n\n

It covers the following factors –<\/p>\n\n\n\n