21 CFR part 11 Compliance

Dating back to Aug of 1997, the FDA's 21 CFR part 11 requirements are not new. However, many companies in the biotech, medical device, pharmaceutical, and life sciences fields still face significant challenges in insuring that their labeling systems are compliant.

The FDA established these standards to protect the public health and insure the adequacy of electronic medical records. As a result of these standards, most food, drugs, medical devices, and cosmetics distributed in the United States must be manufactured in accordance with FDA regulations including the design, control, and printing of material and product labels.

The 21 CFR Part 11 regulations go beyond traditional labeling to include written, printed, or graphic matter on or accompanying the product that is distributed.

As the scope of these requirements has increased and more and more companies have been issued FDA warning letters, implementing a compliance labeling system that meets all of the requirements of 21 CFR part 11 has taken on greater importance for businesses covered by this regulatory statute.

The Problem

You're now required to implement a labeling system as mandated by your customers or a regulatory agency. However, your business is complicated, and if you're going to integrate such a solution, you want to ensure it fulfills the regulatory standards while also resolving any internal process issues.

The Solution

Pragmatyxs’ PXSmartPrint helps organizations meet rigorous regulatory and customer compliance labeling mandates.

This compliance labeling solution allows our customers to accommodate compliance rules while providing an environment that is centrally deployed and managed, easing the administrative burden, lowering costs and enforcing labeling and data standards. Click here to learn more.

Compliance Labeling Links

Below you will find a number of links that will help guide and educate you on the topic of compliance labeling.

• CFR - Code of Federal Regulations Title 21

  Search the CFR Title 21 Database

• 21 CFR Part 11

  Part 11 Electronic Records; Electronic Signatures

• FDA Guidance: 21 CFR Part 11, Electronic Records; Electronic Signatures — Scope and Application

  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).

• FDA: Enforcement Actions

  This page provides links, for example, to documents, lists, policies, programs, and statements relating to Compliance References used by FDA personnel:

• www.21cfrpart11.com

  A collection of useful information on 21 CFR part 11 compliance. Hosted and supported by Waters Corporation Laboratory Informatics

• 21 CFR Part 11-The Biggest Security Regulation You Never Heard Of

  ISSA - The Global Voice of Information Security

• Complying with FDA's 21 CFR Part 11 Regulation

  A Secure Time Management Primer