Annex 11: A comprehensive compliance checklist

In the world of pharmaceutical and life sciences, Annex 11 is significant. It’s a part of the EU’s good manufacturing practice (GMP) guidelines, which ensure the development of safe, high-quality medications. Annex 11 zeroes in on computerized systems – the tech we use every day in our work. It sets the rules for how we should use these systems to ensure that pharmaceutical production and its associated record-keeping is error-free. Compliance with Annex 11 is a must. Companies that don’t follow these guidelines risk product recalls, fines, and damage to their reputation.


Tricentis Staff

Various contributors

Date: Jan. 05, 2024

Understanding Annex 11

Annex 11 isn’t just about following rules; it’s about customer trust. It’s about ensuring that medicines are safe and that records are accurate and reliable. If you can demonstrate that you’re compliant with Annex 11, people can trust you with their health. Consider a factory that manufactures pharmaceutical products. Its computer systems must work perfectly – and that’s where Annex 11 comes in. It serves as a guideline for managing these systems.

Annex 11 covers a lot of ground, beginning with how to test and validate computer systems to ensure they perform as expected. It mandates strong security, requiring you to closely monitor changes made within the systems, keep detailed records, and safely store your data.

Annex 11 is about ensuring that medicines are safe and that records are accurate and reliable. It’s all about trust.

Annex 11 compliance checklist

Ready to explore the technicalities of Annex 11? Let’s get started with an Annex 11 checklist.

Risk management

Risk management is a proactive approach to identifying potential issues before they become actual problems. Annex 11 guidelines recommend a risk management process that identifies, evaluates, and controls any risks related to computerized systems. This includes regular assessments of the system to pinpoint vulnerabilities, followed by immediate mitigation measures to address identified risks.


Your team plays a critical role in ensuring Annex 11 compliance. The guidelines underscore the importance of well-trained personnel who understand how to manage and operate computerized systems. Continuous training programs should be in place to ensure that your people stay up to date with the latest regulations and technological advancements. It’s essential to maintain clear and detailed job descriptions, performance criteria, and competence records.

Suppliers and service providers

To meet Annex 11 guidelines, your vendors should also follow the same set of rules. The guidelines recommend regular monitoring of processes, document review, and performance assessments.

Data and data storage

Data storage systems must be highly secure and regularly backed up.

Audit trails

Audit trails offer a chronological record of system activities for easy tracking and reconstruction of events. Annex 11 mandates the maintenance of audit trails to ensure transparency and accountability in the system’s operations.

Change and configuration management

Annex 11 suggests a step-by-step method for managing configuration changes. This means identifying any proposed changes and determining how changes may affect your system before you make them.

Incident management

Incident management prepares a company for errors, such as when a system stops working or an unauthorized person accesses data. In a nutshell, it’s about quick action, smart fixes, and always striving to do better.

Electronic signatures

Annex 11 stipulates that electronic signatures should be as secure as their handwritten counterparts. It’s important to establish clear procedures for the use, control, and administration of electronic signatures. The integrity, confidentiality, and non-repudiation of the electronic signatures must be ensured at all times.

Batch releases

Annex 11 requires companies to use computerized systems to manage and document batch releases effectively. This involves tracking each batch’s life cycle, validating the processes involved, documenting the batch details, and archiving this information for future reference.


Annex 11 highlights the importance of creating reliable backups of all critical data. These backups should be stored securely, and there should be a mechanism in place to retrieve this data when needed.

By leveraging these types of automated solutions, organizations can shift their focus from the tedious task of manual validation to more strategic initiatives.

Why an automated compliance solution makes sense

In the era of digital transformation, manual validation can be time-consuming and error-prone. This is where automated compliance solutions come into play, aiming to modernize traditional approaches by streamlining the validation process.

Such solutions are particularly beneficial in highly regulated industries where compliance is critical. Adding a digital tool that’s designed to enhance compliance to your broader compliance strategy can increase speed and quality in testing while reducing risk. This concept, known as digital validation, uses digital technologies to improve the effectiveness and efficiency of validation processes.

Take, for example, Tricentis Vera™, a digital validation tool. It’s designed to enable compliance with regulations concerning electronic records and signatures, such as 21 CFR Part 11 issued by the FDA in the United States. Through a unified interface, it can synchronize the review and approval process seamlessly, providing a streamlined user experience.

By leveraging these types of automated solutions, organizations can shift their focus from the tedious task of manual validation to more strategic initiatives. Automated compliance solutions not only enhance efficiency and accuracy, but also provide a more comprehensive approach to meeting compliance requirements.


Following Annex 11 guidelines is more than ticking boxes on a checklist; it’s about manufacturing pharmaceutical products in a way that’s accurate, easy to understand, and regulatorily compliant. These guidelines are in place to ensure that data is safe and can be trusted. Annex 11 covers many topics, from managing risk and using electronic signatures to storing data and more. The guidelines might seem strict at first, but each rule is designed to protect data. Following these rules demonstrates that an organization is committed to doing a good job.

Some organizations may want an efficient, dependable, and quick way to stay in compliance with Annex 11. With digital tools like Tricentis Vera, it’s easier to stay compliant in a highly regulated industry.


Tricentis Staff

Various contributors

Date: Jan. 05, 2024

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