FDA 21 CFR Part 11 Label Compliance

FDA 21 CFR Part 11 Label Compliance

Achieve Compliance for Medical Labeling & Electronic Records Rules

Worldwide, the medical and pharmaceutical industries have faced increasingly aggressive labeling requirements and compliance standards. A recent push for tougher standards was spurred by growing mislabeling and counterfeiting issues. While only a handful of companies fell into these practices, the entire industry now faces increased scrutiny in the form of “track and trace” requirements—and the FDA’s Title 21 CFR Part 11 is perhaps the most complex of them all.

Vivid Data Group helps our customers achieve total FDA 21 CFR Part 11 label compliance while reducing operational costs and improving responsiveness to new guidelines. We offer custom solutions, along with the implementation support and professional services to deploy them rapidly across your entire organization.

FDA 21 CFR Part 11 Label Compliance

How Tough Is FDA 21 CFR Part 11 Label Compliance?

Compliance involves maintaining authoritative electronic records that can be proven to be accurate as a replacement for paper records. In theory, this standard offers almost total accountability for every medical product covered; in practice, the technical requirements are so difficult that they create a burden for many companies. Part 11 requirements include:

  • Electronic signatures must be logged for all shipments and must meet FDA standards for trustworthiness
  • If electronic records are used in lieu of paper records, they must meet FDA standards and count as “authoritative” records for all shipments
  • Electronic signatures must be linked to product records, and audit trails must be implemented and ready for audit at all times

At Vivid Data Group, we know these requirements are strict, but we don’t view them as problems—our solutions have built-in functionality to make Part 11 compliance as easy as printing a shipping label.

Modern Solutions, Central Control

We help you achieve compliance and operational efficiency by giving you central control over your entire labeling process, worldwide. Most compliance challenges begin with scattered, independent label processes at different facilities or locations. These fractured systems create errors, inconsistencies, and the chance for mislabeling. By centralizing your entire label process under one intuitive system, we make compliance easier and more cost-effective.

Our solutions include:

  • Full-lifecycle label management. From the data to the label template to batch number/order information, all the way through to shipping and receiving data, your audit trail is built into your label production system.
  • Electronic signatures. We view electronic signature support as a standard feature and offer systems that automatically link the signature with the product record.
  • Review & approval workflows. Optimize your workflow and slash your risk of labeling errors and product recalls.
  • Auditable security rules. All security protocols and permissions are tracked and ready for audit to prove that your electronic records are authoritative.
  • Efficient, standardized label process. Our systems won’t just bring you into compliance—they’ll standardize your labels across your organization. This cuts costs eliminates costly maintenance of legacy systems and gives you the power to respond to new regulatory requirements.

Achieve Compliance Quickly

Becoming FDA 21 CFR Part 11 doesn’t have to be a painful process. Let Vivid Data Group help you. We will work with you to customize your solution to your business needs and deploy it rapidly.

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