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What’s Part 11?

In the early 1990s, computerized systems were becoming increasingly normal in business, and Industry professionals wanted to reduce paper-based records and signatures. Having no standards for which to model electronic records and signatures, the FDA was tasked with providing guidelines.

In 1997, the FDA introduced Title 21 Code of Federal Regulations Part 11, or, 21 CFR 11, or simply, Part 11, as guidance for pharma manufacturers. Part 11 is what equivocated electronic signatures’ legal equivalence with traditional “wet ink” signatures on paper.

Part 11 is a federally enforceable regulation that emphasizes identity verification, accountability of actions by authorized individuals, and the reporting of obligations.

What does Part 11 mean to Medical Device Manufacturers?

21 CFR 11 compliance requires adherence to the following:

1. Authentic Electronic Records
2. Administrators must grant permissions for document access within the system
3. The system must be capable of generating an audit trail for each record

• Unique Electronic Signatures
• Each user needs a unique digital signature
• Electronic records require:

• Name of the signer
• Date and time of signature
• Type of signature (i.e., quality, reviewer, etc.)

• Record and Signature Interconnectivity
• Traceability must exist between the electronic record and the signer
  • Handwritten signatures scanned into the system apply, as well

• Identification and Password Authentication
• The system must employ at least two identification components:
  • a unique identification code
  • a password

• Training Integration
• There must be training history for anyone using electronic systems requiring electronic signatures and dates

• Effective Change Control Management
• Maintain an audit trail that captures revision and change control procedures

• System Validation
• Electronic systems that manage compliance-related documents must be validated

What’s Annex 11?

EU Annex 11 is directed at products and services manufactured and sold in the EU. It is the European Union equivalent of FDA Part 11 without the weight of enforcement. In other words, it is not federally enforceable like 21 CFR 11.

Instead, it is a strongly recommended, comprehensive guideline that supplements the full set of GMP rules, officially known as the EUDRALEX Rules Governing Medicinal Products in the European Union, Volume 4, Good Manufacturing Practice. These rules apply to all human and veterinary medical products that are sold or manufactured in the EU.

This guidance system mandates electronic records and signatures within the pharmaceutical industry beyond electronic documents, including hardware, personnel, risk management, and software.

The provision covers:

• Accuracy checks
• Archiving and records
• Audit trails
• Batch releases
• Business continuity
• Change management
• Configuration management
• Data storage
• Electronic signatures
• Periodic evaluation
• Printouts
• Security
• Validation of data

Annex 11 includes all computerized systems that are part of the GMP-related activities to reflect the increased use and complexity of automated systems. These include the following:

• Clinical trials
• Corrective and preventative action (CAPA)
• Distribution
• Laboratory testing
• Material supply
• Process controls
• Production
• Quality system
• Records and documentation
• Product release
• Storage

What does Annex 11 mean to Medical Device Manufacturers?

Although Annex 11 only speaks to medicinal products and pharmaceuticals, (as of 2022), many medical device companies comply with these guidelines in the assumption they will be relevant in the future.

A former FDA inspector recommended that medical device makers who plan to market their products in the EU comply with Annex 11 now for sake of meeting future regulations, easier.

What’s the Difference?

Interested to know more about Good Documentation Practices and Electronic Records Requirements?

Contact Prime Path Medtech today! One of our friendly medical device quality professionals will be happy to help ensure that your electronic and physical records meet the required standards and set your mind at ease.

Regulations mandated by ISO (International Organization for Standardization) and CFR (Code of Federal Regulations) specify the requirements for manufacturers to implement quality management systems that ensure the safety and security of their products. A quality management system, or QMS, helps to demonstrate an organization’s ability to follow regulations and meet the needs of their customers. And when it comes to medical devices, both ISO 13485 and 21 CFR 820 may seem similar in their goals, but there are a few key differences. Let’s look at an overview of each of these regulations.

What is ISO 13485?

The 2016 version of ISO 13485 is a voluntary standard based upon the general quality management system outlined by ISO 9001:2008. This rule is frequently utilized by manufacturers to establish and maintain a system that can meet the demands of the medical device market. The latest version of ISO 13485 includes heightened regulatory emphasis on product safety, risk management requirements in products and processes, and improvements of reporting systems to regulatory bodies.

What is 21 CFR 820?

FDA 21 CFR 820 is the quality system approved by the Federal Drug Administration of the United States. Its requirements are aimed at ensuring the safety and efficacy of medical devices. While the rule defines a specific quality management system to follow, it is up to the manufacturers to determine which limits apply to their processes and products. In other words, the maker of the medical equipment is responsible for determining how they intend to comply with QMS set by the FDA.

Some Major Differences

While both standards involve the implementation of quality standards for organizations, there are a few key differences between the two.

1. 21 CFR 820 is a mandatory quality system for the distribution and regulation of medical devices in the US, while ISO 13485 is neither a regulation nor law. Think of the ISO requirements as an internal endeavor by the company to ensure customer satisfaction while the FDA requirements are imposed externally by a government body.

2. ISO 13485 is a standard that does not mandate a specific quality management system structure. But with 21 CFR 820, companies should line themselves up with the outlined documentation structure. Fulfilling the ISO requirements is known as conformance, while fulfilling the FDA requirements is known as compliance.

3. ISO 13485 is a globally accepted standard that provides ways to comply with general regulatory requirements, while CFR 820 is a regulation mandatory for US manufacturers. Countries outside the US can still have their own laws and regulations.

4. The standards created by ISO 13485 are based on input by the FDA and other members of ISO, but the CFR 820 is not based on input from the International Organization for Standardization.

A Change in Standards?

While both standards exist simultaneously and are used for different purposes, the FDA has revealed their plans to adopt ISO 13485 as the new standard for medical device companies in the US, essentially replacing 21 CFR 820. This intends to achieve more global harmonization and make it easier for US companies to comply internationally. It will also simplify the quality management systems of companies who are looking for FDA approval for medical devices. But until then, remember what sets these standards apart and how they affect your business.