European Annex 11

The Annex 11 Computerized Systems of the European Medicines Agency (EMEA) applies to all computer systems used as part of the activities regulated by GMP Guidelines to Good Manufacturing Practice .

Overview

The 21 CFR Part 11: Electronic records and electronic signatures, from U.S. FDA, is intended to allow the widest possible use of electronic technology. Compliance of the 21 CFR Part 11, is a prerequisite for all companies that want to offer their products in the U.S. and in the global market. The standard requires that systems that process data electronically ensure safety, traceability and data integrity. To achieve these goals, those systems must meet several requirements including access to the system through individual credentials, the traceability of operations through audit trails, the use of electronic signatures, the availability of documentation of specific systems.

The current revision of Annex 11 to Volume 4 of the EU- GMP, entered into force on 30 June 2011 and want to give a response to the increased use of computer systems and their increasing complexity. The Annex 11 applies to all computer systems operating in areas governed by good manufacturing practices for medicinal products for human use and veterinary use. These systems need to be validated and IT infrastructure needs to be qualified . With "Validation of computer systems " means all the verification activities of a computer system to ensure reliability consistent with the intended uses . The overall objective of the validation is to ensure the reliability of computerized data and systems that replace manual operation , in summary, it must be ensured that there is no decrease in product quality, process control or quality assurance. It must also be verified that there is not any increased risk to the functional process that manages the computer system.