EU GMP Annex 11 applies to computerised systems used as part of GMP-regulated activities. The application should be validated, the supporting IT infrastructure should be qualified, and controls should be proportionate to risk.
Key control areas include:
Annex 11 applies when a computerised system is used as part of an EU GMP-regulated activity. This can include systems used to create, process, maintain, retrieve, or archive maintenance, calibration, equipment, and validation records that support GMP operations.
The required controls and validation effort should be based on intended use, data criticality, system complexity, and documented risk.
Relevant capabilities may include controlled access, audit trails, accurate record retrieval, electronic signatures, data protection, backup and restoration, change control, and information needed for periodic evaluation.
The supporting IT infrastructure should also be appropriately qualified and maintained.
GxPReady supports: Technical controls, standardized functionality, controlled system development, validation documentation, and implementation support.
The customer remains responsible for: Intended use, risk assessment, validation approval, user access, procedures, training, supplier oversight, change control, and periodic review.
Annex 11 does not establish an official certification program for software products. A supplier can provide suitable controls and validation evidence, but the regulated organization remains responsible for its intended use and compliant operation.
General maintenance tools may not provide the access control, audit-trail, data-integrity, backup, security, retention, and validation support expected for GMP computerised systems.
Complexity can expand validation scope and operational burden. The better system is one that reliably supports its defined intended use with appropriate controls, documentation, and oversight.
Annex 11 addresses computerised systems used in GMP activities, including systems that create, process, maintain, retrieve, or archive regulated data and records.
For pharmaceutical and other organizations operating under EU GMP, maintenance, calibration, equipment, and validation information may form part of the GMP record. Depending on intended use and risk, the supporting system may need to provide:
No. Annex 11 does not require every record to use an electronic signature. When electronic signatures are used, they should be permanently linked to the associated record, include the date and time, and have the same impact as handwritten signatures within the organization.
Annex 11 applies to computerised systems used as part of GMP-regulated activities. The specific controls and validation effort should be based on intended use, system complexity, data criticality, and documented risk assessment.
No software product makes an organization compliant by itself. GxPReady provides technical controls and validation support, while compliance also depends on configuration, procedures, user administration, training, supplier oversight, and controlled use.
GxPReady includes a structured validation package intended to support customer validation activities. Its standardized design and limited configuration can reduce validation effort compared with heavily customized enterprise systems, while the customer remains responsible for approving intended use and validation.
GxPReady supports controlled access, audit trails, electronic records, authenticated actions, record retrieval, and related validation activities. Applicable procedures, training, periodic review, backup, security, and administrative controls remain part of the complete regulated system.
