9 Key Areas for EudraLex Annex 11

Annex 11

Key Areas in Annex 11

EudraLex Annex 11 is a European Union guideline that provides guidance and promotes robust, secure, and reliable use of computerized systems in the pharmaceutical industry, which improves patient safety and product quality. It is part of the EudraLex Volume 4 GMP guidelines.

There are a number of key areas in Annex 11 that need to be reviewed to ensure that your systems and processes are in compliance and will stand up to the scrutiny of a HPRA (and other European Regulatory agency) audits. It covers various aspects related to computerized systems, including:

1. Compliance and Validation

Validating computerized systems is crucial to ensure their reliability, compliance, and fitness for intended use. There are a number of essential documents that are required for any computer system validation in a pharma plant.  Documents like Validation Master Plan, Validation Plan, User Requirements Specification, Design Qualification/Configuration Specification, Installation Qualification, Operation Qualification, Performance Qualification and Validation Summary report. 

2. Risk Management

Risk assessments need to be completed on all computer systems in order to identify and mitigate risks associated with data integrity and security.

3. Data Integrity

Unauthorised access and loss of critical data needs to be prevented.  Audit trails are key and should be reviewed periodically.

4. Incident Management

All incidents need to be identified and analysed.  Rootr causes of critical incidents should drive the corrective and preventative actions. 

5. Electronic Records and Signatures

Companies must implement secure electronic signature processes and maintain accurate records.

6. Change Control and Configuration Management

Changes to computerized systems (e.g., software updates) require proper change control procedures. Configuration management ensures consistency and traceability.

7. Training and Personnel

Adequate training for personnel using computerized systems is essential and must be documented.

8. Supplier Management

Companies must assess and manage suppliers of computerized systems. Supplier audits and agreements are critical.

9. Periodic Evaluation

Regularly evaluating system performance ensures ongoing compliance.  Companies should review and update systems as needed.

Gap Analysis

Dataworks provide services to complete Gap Analysis on computers systems and also provide resources to perform remediation activities.

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Contact Us today to learn more about how Dataworks can asisst your oganisation with our validation services.

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