The FDA’s Code of Federal Regulation(CFR) 21 Part 11 allows Medical Device and Life Science organizations to use electronic records and signatures in place of paper.

The regulation applies to all aspects of the research, clinical study, maintenance, manufacturing, and distribution of medical products, and covers:

• Required records that are maintained in electronic format in place of paper format
• Required records that are maintained in electronic format in addition to paper format, and that are relied on to perform regulated activities
• Records submitted to FDA in electronic format
• Electronic signatures that are intended to be the equivalent of handwritten signatures

To meet these regulations, companies turn to software to help bridge the gap. A piece of software by itself cannot be compliant, so any critical software must be supported by a properly conceived and performed validation project, normally following Good Manufacturing Practice (GMP).

FDA 21 CFR Part 11 helps organizations reduce the cost of managing and documenting their entire labeling life-cycle, from routing and approval workflow, version control and comparison, to audit trails and reports.

By becoming FDA 21 CFR Part 11 compliant, manufacturers will benefit from:

• Reduced costs by removing manual and paper processes while improving workflow processes
• Improved traceability – electronic records are easier to gather, filter, present, and store information for internal use or FDA audits
• The ability to print, reprint and reconcile labels at any time
• Stronger controls over users’ ability to design, amend and approve labels
• Better management of global data including product data, symbols, graphics, and languages

FDA Title 21 CFR

• Part 1, Subpart B — General Labeling Requirements
• Part 11 — Electronic Records; Electronic Signatures
• Part 26 — Mutual Recognition of Pharmaceutical Good Manufacturing Practice Reports, Medical Device Quality System Audit Reports, And Certain Medical Device Product Evaluation Reports: United States and the European Community
• Part 101 — Food Labeling
• Part 201 — Drug Labeling
• Part 203 — Prescription Drug Marketing
• Part 801 — Medical Device Labeling
• Part 803 — Medical Device Reporting; Subpart E — Manufacturer Reporting Requirements
• Part 809 — In Vitro Diagnostic Products for Human Use
• Part 820 — Quality System Regulation
• Part 821 — Medical Device Tracking Requirements
• Part 1271 — Human Cells, Tissues, and Cellular and Tissue-Based Products; Subpart D — Current Good Tissue Practice
• Part 1302 — Labeling and Packaging Requirements for Controlled Substances