Do You Know Enough About EU Annex 11 For Computer Systems Validation?

April 22nd, 2014 by

Computer Systems ValidationComputerized systems play critical roles in helping GxP firms improve their operating standards and production capabilities. In order to maintain compliance and product marketability within the European and international sphere, it’s essential that these organizations follow the guidelines specified in EudraLex Volume 4’s Good Manufacturing Practice principles.

While these guidelines cover a wide range of specific areas, those addressed in EU Annex 11 are of significant importance to firms that use modern technologies and wish to perform comprehensive validation of their IT and embedded systems and comply with GMP principles.

What Does Annex 11 Cover?

Any and all computerized systems employed in GMP-regulated actions are subject to the principles outlined in Annex 11. Access the PDF here. The annex defines computerized systems as both software and hardware components. It covers a number of general subjects, like risk management, cooperation between personnel and the evaluation of third-party suppliers and service providers.

Annex 11 also mentions certain aspects of project validation, such as the documentation and reports that need to be generated throughout the validation process. In addition, the Annex recommendations deal with a number of implementation-specific IT system factors, such as data storage, printout handling, audit trails, security controls and periodic evaluation.

Maintaining Annex 11 Compliance

The scope of Annex 11 guidelines means that comprehensive compliance must be somewhat diverse. For instance, the same risk-management solutions that apply to physical data storage aren’t necessarily going to work with incident management or archiving. These implementation differences also affect the way validation and supplier audits function for firms trying to follow guidelines. Click here to read more about supplier audits.

Many companies lack the resources needed to adopt an effectively diverse approach to guideline compliance without external help. While third-party consultants are often called upon for assistance, these consultants themselves need to maintain some minimum level of quality in order for the work they perform to meet applicable standards.

Integrated Compliance Between Annex 11 and FDA

Stress testing is vital to continued compliance, and firms often implement mock audits designed to parallel FDA or ISO inspections. It should be noted, however, that such audit awareness goes both ways; it can help firms meet the demands of guidelines like Annex 11 as well as maintain FDA readiness.

Instead of solely relying on mock audits, for instance, ‘technology aware’ firms also implement features such as documented audit trails in compliance with Annex 11 recommendations. This preparation allows them to prove that they’re doing things correctly when the time comes for an official review.

Building a comprehensive compliance system is really about adopting a big-picture perspective. Firms that want to keep up with IT recommendations, like those contained in EudraLex and other multinational guidelines, implement compliance systems that permit them to maintain superior awareness of their business practices and facilitate better handling of compliance procedures in general.

The guidelines presented by EU Annex 11 definitely help GxP companies meet EU marketability standards, but they also can help them realize more efficient internal operations.

GxP-CC is a global team of compliance experts sought out by leading medical device, bio-pharmaceutical and dental lab firms for consultative assistance. With clients in more than 28 countries, they are well-versed in international regulatory requirements. Contact them today to discuss your compliance needs.

About this author:

Dr. Hussein has over 15 years of experience in the GMP industry as a successful advisor for top medical device and pharmaceutical companies. In 2008 Dr. Hussein was named as an assessor for project management in the “German Society for Project Management” (GPM). Dr. Hussein holds a Master’s in Physics and a Master’s in Biomedical Engineering from the University of Hannover in Germany. He also holds a PhD in Physics from the University of Luebeck in Germany.

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