Important Difference between 21 CFR part 11 and EU Annex 11

21 CFR part 11 and EU annex 11 both are guidance for the electronic records and electronic signature.

The guidances are applied to the computerized systems that used to store the electronic data.

FDA has made regulation 21CFR part 11 for the US-based pharmaceutical companies as well as the companies want to market the drug product into the US market.

Likewise, the European Union also having a GMP guideline known as EU annexure 11.

EU annexure 11 is a somewhat broader view than the FDA’s 21 CFR part 11.

Here is the main difference between 21 CFR part 11 and EU annex 11 is elaborated in an easy and proper way of understanding.

Difference between 21 CFR part 11 and EU annex 11

21 CFR part 11:

  1. The USFDA published 21 CFR part 11 guidelines in 1997.
  2. The guideline title “Electronic records and Electronic signature”
  3. This guideline describes only about GxP system. Such as GMP, GLP, GDP and GCP.
  4. The USFDA has made it a regulation for the USA and companies who want to market the drug product into the USA.
  5. 21 CFR part 11 is covered only electronic records and electronic signatures.
  6. The objective of 21 CFR part 11 is data should be as trustworthy and reliable as paper records and handwritten signature.

EU Annex 11:

  1. The European Union published an EU GMP annex 11 guideline in 1991.
  2. The guideline title “Computerised system”
  3. This guideline is not only GxP but also covers other areas like validation, Risk management, IT service and security, documentation management project data. Contract and supplier services.
  4. EU annex 11 is a guideline not necessarily to consider it as a regulation. It is important to note that, it is not a legal requirement.
  5. As said in point number 3 it is not only applicable to ERES but also to other areas.
  6. The objective of EU annex 11 is by using a computerized system to ensure product quality and product assurance with no increase in risk.

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Hang on to know more about the difference between 21 CFR part 11 and EU annex 11 read it down.

Where 21 CFR part 11 applies?

21 CFR part 11 is a regulation of the FDA. It applies to the drug manufacturer, biologics developers, biotech companies, contract research organizations (CRO) and other regulated industries.

Implementation of 21 CFR part 11 includes audit trails, electronic records, electronic signature, audit, system validation and the supporting system that involved in the processing of electronic data, that requires to maintain as per FDA’s predicate rule.

What is predicate rule?

Then predicate rule is any requirement set forth in the federal food, drug and cosmetic act, the public health service act, or any other FDA regulation other than 21 CFR part 11.

What is 21 CFR part 11 contains?

As per the FDA’s code of federal regulation (CFR) total of 50 codes are available for different industries. Out of 50 codes, 22 represent food and drugs.

21 CFR part 11 contains three subparts,

Subpart A: General Provision

Subpart B: Electronic Records and

Subpart C: Electronic Signature

Where EU GMP annex 11 applies?

EU GMP Annex 11 is a part of Eudralex Volume 4. Eudralex Volume 4 represents Good Manufacturing Practice Medicinal Product for Human and Veterinary use. Annex 11 represents a computerized system.

EU GMP Annex 11 is a guideline in European Union countries for computerized systems.

In Annex 11 computerized system applies to the software, hardware, validation, operational phase, supplies and service provider, risk management, personnel and electronic signature.

21 CFR part 11 is applicable only for electronic records and electronic signature but EU GMP annex 11 is not limited to electronic record and electronic signature.

What is electronic signature?

The Electronic signature is an e-signature or else can say digital signature. Paper records are signed manually but electronic records can be signed electronically.

An Electronic signature is expected to have,

1. Have the same impact as handwritten signatures within the boundaries of the company.

2. Should be permanently linked to the respective record.

3. Should present time and date that they were applied.

What is electronic record?

An electronic record is a record that is store in the system in digital form. May be in a static form or in dynamic form.

Conclusion:

When 21 CFR part 11 and EU annex 11 is used in place of manual operation, it is important to ensure the product quality and safety. 21 CFR part 11 and EU annex 11 is created to ensure the same thing in the pharmaceutical industry.

The 21CFR part 11 is part of FDA regulation and EU annex 11 is a guideline of the EU. As per FDA it is mandatory to follow the regulation but as per European Union it is not. As per EU manufacturers can comply with FDA also acceptable in the case of electronic records and electronic signatures.

Finally, the difference between 21 CFR part 11 and EU annex 11 we understand and there is no difference between both. The purpose of both the guidelines are the same but 21 CFR part 11 is restricted up to certain limitations and EU annex 11 is a broader way of compliance.

Most of the pharmaceutical companies are following 21 CFR part 11 compliance to acquiring the market of the USA.

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