EudraLex Volume 4 Annex 11 is a key regulatory guideline issued by the European Medicines Agency (EMA) that governs the use of computerised systems in the pharmaceutical industry, within the European Union (EU). It is part of the EU's Good Manufacturing Practice (GMP) framework, specifically focusing on how to ensure that computerized systems used in drug manufacturing, distribution, and quality control meet regulatory standards for quality, integrity, and safety.
Annex 11 works alongside , the U.S. Food and Drug Administration (FDA)'s regulation for electronic records and electronic signatures, although there are some differences in scope and application.
This page offers a brief overview of technical functionalities that satisfy the above requirements and support implementation within an organisation. It does not delve into comprehensive details of Annex 11, or serve as legal counsel for achieving absolute compliance.
General
Risk Management
Prior to implementation, Seal conducts a risk assessment to determine extent of validation necessary that aligns with the customer's regulatory needs.
Project Phase
System Validation
Seal is validated and undergoes re-validation when new versions or standard updates are released. Unless required, customers do not need to conduct additional validation activities.
Operational Phase
Audit Trail
Seal captures all user actions, including the responsible person, date, and time, generating time-stamped audit trails.
These audit trails preserve previously recorded information and cannot be modified by users, ensuring data integrity.
Personnel Training
Seal includes training management capabilities, enabling relevant employees to be correctly trained on respective SOPs.
Supplier Management
Seal enables companies to create and manage supplier-related activities such as, but not limited to, vendor qualification, approved supplier list, and supplier certificates,
Change Management
Seal enables tracking and management of changes across documentation and procedures.
Electronic Signatures
Users are required to authenticate their identity with a unique username and password before signing a document to prevent unauthorised signatures.
