What is EU Annex 11?

Annex 11 is the FDA 21 CFR part 11 European equivalent. It is a guidance system for electronic records and electronic signatures in the pharmaceutical industry. Annex 11 and FDA 21 CFR are two essential resources available to regulated life-science professionals regarding the validation of computer systems.

WHO Guidelines Annexure 11?

Annex 11 was created to ensure that when a computer is used in place of a manual operation in the manufacture of pharmaceuticals, there is no further risk to limb or paw when it comes to product quality, efficacy or patent safety.

Does Annex 11 apply to medical devices?

Strictly speaking, Annex 11 applies only to medicinal products and not to medical devices.

What are EU GMP standards?

Good manufacturing practice (GMP) describes the minimum standard that a medicines manufacturer must meet in their production processes. The European Medicines Agency (EMA) coordinates inspections to verify compliance with these standards and plays a key role in harmonising GMP activities at European Union (EU) level.

What is the purpose of 21 CFR Part 11?

CFR stands for “Code of Federal Regulation.” 21 CFR Part 11, in particular, details the criteria under which electronic records and signatures are considered to be trustworthy and equivalent to paper records.

What is the difference between Part 11 and Annex 11?

Annex 11 is a detailed guide to the areas of compliance that need documentation. Annex 11 points to risk assessment as the start of compliance activities. Part 11 differentiates security for open and closed systems, with extra security measures for open systems but without reference to risk or criticality.

How do you become 21 CFR Part 11 compliant?

Medical device companies can use these tips to ensure compliance with 21 CFR Part 11:

  1. Determine whether 21 CFR Part 11 applies to your company.
  2. Follow best practices in data protection and password security.
  3. Establish clear audit trails for traceability.
  4. Follow guidelines on electronic signatures.

What is the scope of Annex 11 part 11?

Annex 11 Part 11 Scope/Principle Computerized systems as part of GMP regulated activities. Application should be validated. IT infrastructure should be qualified. Electronic records and electronic signatures as used for all FDA regulated activities. Focus Risk- based quality management of computerized systems.

When was Annex 11 added to the GMP?

In 2011, the EU updated Annex 11 to include all computerized systems that are part of the GMP-related activities to reflect the increased use and complexity of automated systems. (3) These include the following: Another hallmark of 2011’s newly added guidelines is the inclusion of electronic forms, documents and signatures.

Is the FDA Annex 11 a legal requirement?

While Annex 11 is not a legal requirement, it is a strongly recommended guideline, as a popular pair of fictional pirates may have once voiced. In contrast, the FDA established Part 11 in 1997 as guidance for pharma manufacturers after electronic online records and signatures became more common for product system validations.

When did EudraLex Annex 11 come into effect?

In January 2011, the European Commission published a new version of Volume 4, EU Guidelines to Good Manufacturing Practice, Medicinal Products for Human and Veterinary Use, Annex 11, Computerised Systems .ᅠThis version was in effect as ofᅠJune 30, 2011.