Compliance Checklist – CFR Title 21 Part 11 and EU Annex 11

This checklist is intended to describe 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) and EU Annex 11.

In March of 1997, FDA issued final part 11 regulations that provide criteria for acceptance by FDA, under certain circumstances, of electronic records, electronic signatures, and handwritten signatures executed to electronic records as equivalent to paper records and handwritten signatures executed on paper. These regulations, which apply to all FDA program areas, were intended to permit the widest possible use of electronic technology, compatible with FDA’s responsibility to protect the public health.

In 2011, the European Union (EU) revised its guidance for the life cycle of computerized systems to reflect the increased use and complexity of automated systems in the pharmaceutical industry. The guidance, called Annex 11, also was revised in response to an alarming number of problems detected in computerized systems. Annex 11 wants to ensure the computerized systems you use to manufacture medicinal products have no adverse impact on product quality, product efficacy, or patient safety. In addition, when a computerized system replaces a manual operation, Annex 11 wants to ensure there are no increased risks.

We are issuing this checklist to describe how we exercise these enforcement and requirements to reduce your concerns in the areas for validation, audit trails, record retention, record copying, and legacy systems. If you have any specific questions about this checklist please don’t hesitate to contact us and our Quality Department.

Compliance Quick Reference Guide – CFRTitle21Part11 and EU Annex 11

The United States Food and Drug Administration (FDA) and the European Commission have defined regulations for the conditions under which regulated companies can submit electronic records in lieu of paper documents.

These regulations define the measures that must be in place to ensure the integrity, trustworthiness and reliability of the electronic records. The regulations define and require three types of controls:

  1. Administrative controls, e.g. the definition of policies such as the identification of individuals and non-repudiation of electronic records.
  2. Procedural controls, e.g. Standard Operating Procedures for using and maintaining the system.
  3. Technical controls, e.g. functions built into the software such as security and access to the system as well as the audit trail

For compliance with the regulation all three of the above controls must be implemented.

Key Industry Terminology

rfxcel is the leading enterprise software for supply chain and traceability. Major pharmaceutical companies, independent CPOs/CMOs, and wholesalers rely on rfxcel’s expertise in compliance software and support. rfxcel has specialized in core pharmaceutical areas including compliance, tack and trace, serialization and environmental monitoring. Along with a global team and strategic partnership with Verizon, rfxcel has become the #1 independent traceability solution . rfxcel supports its customers in their decision making with rfxcel’s unique 360° approach encompassing capabilities covering global and local markets. rfxcel is committed to its primary mission of supporting customers needs regarding compliance regulations. With absolute visibility into customers’ products, rfxcel is provides value beyond compliance, improving patient safety, customer control and peace of mind.

Seven Secrets of Serialization

Do you know what’s happening to your products out there in the global marketplace? That knowledge could be the difference between security and vulnerability for you and your customers. Traceability has become a key tool for quality improvement in several industries and is a vital weapon in the war against counterfeits. Your supply chain peers tell us that implementing and managing traceability or serialization software is one of their key concerns. It is indeed a challenge but by learning from their experience, and using an experienced vendor, it doesn’t have to be as difficult as you think.

At rfxcel, we design software systems to handle supply chain traceability in fast-moving, highly regulated and fully validated environments like the pharmaceutical industry. In this short white paper, we’ll share some of our design philosophy and some practical things we’ve learned along the way during customer implementations.