Annex 11 & Part 11: What’s the Difference?

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?

 Annex 11CFR Part 11
ScopeComputerized GMP applications should be validated; IT infrastructure qualified.Electronic records/signatures for FDA-regulated organizations.
FocusComputerized quality management systemUse of electronic signatures/records in open/closed computer systems.
ObjectiveComputerized systems should yield the same results as manual systems with no risk increase.The electronic records/signatures captured and stored should be as reliable as wet signatures.
Relevance and ValidationGMP-relevant; referenced elsewhere tooPer GMP, GDP, GLP, GCP, and medical device validations

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.