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EU Regulations

 

EU Annex 11

Annex 11 is one of the several guidance documents of the European GMP Guidelines. It defines the terms of reference for computerized systems used by organizations in the pharmaceutical industry. Essentially, Annex 11 is a checklist that enables the European regulatory agencies to establish the requirements for computerized systems that relate to pharmaceutical products and medical devices. The guidelines set forth by the Commission of the European Committees are not too distant from their US counterpart created by the FDA (21 CFR Part 11). Basically, EU Annex 11 is the EU’s equivalent to Title 21 CFR Part 11, although it has different guidelines and regulatory practices than the latter. Annex 11 is suggesting that risk assessment is the beginning of compliance for all computerized systems, while the FDA guideline focuses exclusively on electronic signatures and records within those systems. 

Amongst other things, Annex 11 defines the criteria under which electronic records and electronic signatures are managed.

It’s important to note however that Annex 11 is not a regulation, like the FDA 21 CFR Part 11 rule is. Annex 11 is a guideline and is key to compliance with GMP principles in EU directives (regulations) covering human and veterinary medicinal products.

 
Why Follow Annex 11 Guidelines?

By introducing Annex 11 at your organization, you effectively can streamline your business processes, reduce turnaround time and costs, all by establishing criteria for the use of electronic records and signatures. If it were not for guidelines such as Annex 11 and rules such as 21 CFR Part 11, we would be unable to manage records and other electronic content in a compliant way. The benefits of managing this content electronically are unparalleled, significantly reducing the risk of human errors, reducing operational costs, and speeding up time-to-market.

 
Things to Note

There are three main areas in which regulated companies must look at as primary areas of focus when dealing with Annex 11:

The features of your system: There is a range of features that are required by Annex 11 when implementing a computer system to manage electronic records. Do your research here to align with these requirements.

Standard Operating Procedures: As with all regulated industries, the companies that operate within them are governed internally by the Standard Operating Procedures they use.

System Validation: When implementing an electronic system for the use in regulated activities, you must ensure that you demonstrate with documented evidence that the electronic system is fit for its intended use. In other words, demonstrate that your system does what it should do. You must have controls in place that allow you to identify when the system doesn’t function as per its intended use.

 
EU Annex 11 Vs. CFR Part 11

 

EU Annex 11

CRF Part 11

Scope

All computerized systems as part of Good Manufacturing Practice;
applications should be validated and IT infrastructure qualified.

Electronic records and signatures that are used for any FDA-regulated
activities by life sciences and other organizations.

Focus

Quality management of computerized systems from a risk-based standpoint.

The use of electronic signatures and records in open or closed computer systems

Objective

The use of a computerized system should result in the same quality assurance
and product quality as manual systems with no risk increase.

The electronic records and signatures captured and stored should be as reliable
and trusted as paper documents and wet signatures.

Relevance and Validation

Relevant to GMP but referenced in other areas as well.

Relevant to and based on validation according to GMP, GDP, GLP, GCP, and medical devices.