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