Comply with Part 11 Digital Signature Regulations of Title 21 CFR

FDA regulation, specifically Part 11 of Title 21 of the CFR , defines the criteria under which the FDA considers that electronic records, electronic signatures, and handwritten signatures signed on electronic records are reliable and generally equivalent to paper records and signed handwritten signatures. on paper.

GlobalSign’s PDF Signing Certificates (which are part of the Adobe Approved Trust List ) create digitally signed documents in compliance with FDA requirements, including how the signature appears on the document and how the signature and document are linked. For more details, see the 21 CFR Part 11 Audit Ancillary Document, which describes how our solution addresses each regulatory component.

Features and Benefits

  • Certificate stored on the USB token to protect the signing credential.
  • Compatible with Adobe Acrobat, LiveCycle and other subscription applications.
  • Third-party time stamp and long-term signature validation included.
  • Add customizable approval signatures, such as an image of your physical signature or an engineering seal.
  • Certify documents to prove authorship, finalize content, and protect against future tampering.

Title 21, Part 11, of the Code of Federal Regulations (CFR) defines the criteria for electronic data integrity as established by the US Food and Drug Administration (FDA). FDA-regulated industries such as medical device manufacturers and pharmaceutical companies must comply with CFR 21 Part 11 to ensure accurate electronic records and signatures.

However, meeting these requirements can be difficult and time-consuming. This blog will explore the common challenges of complying with CFR 21 Part 11 and discuss ways to mitigate them.

The challenges of complying with CFR 21 Part 11

Compliance typically involves creating work instructions to meet each specific 21 CFR Part 11 regulation, developing validation protocols to ensure proper configuration, operation, and performance of equipment and software, creating standard operating procedures (SOP) and extensive training for personnel using the equipment and programs.

Any tool that facilitates this process is helpful.

Many manufacturers in FDA-regulated industries use our OLYMPUS CIX100, the technical cleanliness inspector. Built with an intuitive interface, efficient data acquisition, and fast reporting options, the CIX100 system can help you quickly and easily assess the cleanliness of manufactured components to determine if they meet company and international standards.