![]() ![]() This document provides guidance to persons who, in fulfillment of a requirement in a statute or another part of FDA's regulations to maintain records or submit information to FDA 3, have chosen to maintain the records or submit designated information electronically and, as a result, have become subject to part 11. This guidance is intended to describe the Food and Drug Administration's (FDA's) current thinking regarding the scope and application of part 11 of Title 21 of the Code of Federal Regulations Electronic Records Electronic Signatures (21 CFR Part 11). If you cannot identify the appropriate FDA staff, call the appropriate number listed on the title page of this guidance. If you want to discuss an alternative approach, contact the FDA staff responsible for implementing this guidance. ![]() You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. ![]() This guidance represents the Food and Drug Administration's (FDA's) current thinking on this topic. Guidance for Industry 1 Part 11, Electronic Records Electronic Signatures. Approach to Specific Part 11 Requirements.Overall Approach to Part 11 Requirements.Manufacturers Assistance Phone Number: 80 or 30Ĭenter for Food Safety and Applied Nutrition (CFSAN) Phone: the Voice Information System at 80 or 30ĭivision of Small Manufacturers, International, and Consumer Assistance (HFZ-220) Selecting a region changes the language and/or content on for Biologics Evaluation and ResearchĬenter for Drug Evaluation and Research (CDER)Ĭenter for Biologics Evaluation and Research (CBER) Acrobat embeds the encrypted message digest in the PDF, certificate details, signature image, and a document version when signed. When you apply a certificate-based signature, Acrobat uses a hashing algorithm to generate a message digest, which it encrypts using your private key. The signature is verified when recipients open the document. The certificate is a credential that is automatically applied to the signed document. The private key is used to create the certificate-based signature. The digital ID contains a private key and a certificate with a public key, and more. To sign a document with a certificate-based signature, you must obtain a digital ID or create a self-signed digital ID in Acrobat or Acrobat Reader. It can be easily verified and informs recipients whether the document was modified after the signer initially signed it. Unlike a handwritten signature, a certificate-based signature is difficult to forge because it contains encrypted information that is unique to the signer. Additional checks in the Preflight toolĪ certificate-based signature, like a conventional handwritten signature, identifies the person signing a document.Analyzing documents with the Preflight tool.Automating document analysis with droplets or preflight actions.Correcting problem areas with the Preflight tool.Viewing preflight results, objects, and resources.PDF/X-, PDF/A-, and PDF/E-compliant files.Playing video, audio, and multimedia formats in PDFs.Add audio, video, and interactive objects to PDFs.Edit document structure with the Content and Tags panels.Reading PDFs with reflow and accessibility features.Capture your signature on mobile and use it everywhere.Overview of security in Acrobat and PDFs.Securing PDFs with Adobe Experience Manager.Convert or export PDFs to other file formats.Hosting shared reviews on SharePoint or Office 365 sites.Working with component files in a PDF Portfolio.Add headers, footers, and Bates numbering to PDFs.Send PDF forms to recipients using email or an internal server.Troubleshoot scanner issues when scanning using Acrobat.Change the default font for adding text.Enhance document photos captured using a mobile camera.Rotate, move, delete, and renumber PDF pages.Asian, Cyrillic, and right-to-left text in PDFs.Grids, guides, and measurements in PDFs.Access Acrobat from desktop, mobile, web. ![]()
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