EMA · EUROPEAN UNION

Native EU GMP Annex 11 compliance.

Validated computerised systems, data integrity and audit trails ready for EMA inspection.

The DROME platform was engineered to meet EU GMP Annex 11 and GDP Guidelines requirements from the architecture up, not as an afterthought.

Annex 11

Computerised systems

GDP

Proper distribution

Annex 15

Qualification & validation

GAMP 5

Cat. 4 configurable

IQ/OQ/PQ

Ready to ship

CE-marked hardware

REGULATIONS COVERED

Every article. Every requirement.

Click each regulation to see how DROME addresses each requirement specifically.

EU GMP Annex 11

Computerised Systems

Fully supported

Governs all computerised systems used in activities covered by European Good Manufacturing Practice.

Clause 4.2System validation with a documented validation plan, specifications and tests.

Clause 7.1Data stored securely and accessible throughout the required retention period.

Clause 8Automatic audit trails with date, time, operator and changes made.

Clause 10User management with role-based access control and passwords.

Clause 12.4Data backup and recovery with documented and tested procedures.

How DROME complies

Validated system with IQ/OQ/PQ documentation, immutable audit trail, full RBAC and automated backup with a documented recovery SLA.

EU GDP Guidelines

Good Distribution Practice

Fully supported

EMA guidelines for the proper distribution of medicines, including temperature control during storage and transport.

Ch. 3.2Continuous monitoring and temperature logging in storage facilities.

Ch. 3.3Documented temperature mapping for all storage areas.

Ch. 5.4Qualification procedures for refrigeration equipment.

Ch. 7.2Temperature deviation management with documented CAPA.

How DROME complies

Continuous monitoring, automatic temperature mapping, documented equipment qualification and integrated CAPA workflows.

EU GMP Annex 15

Qualification & Validation

Validation package available

Establishes requirements for equipment qualification and the validation of processes and computerised systems.

Sec. 10Installation (IQ), operational (OQ) and performance (PQ) qualification.

Sec. 12Verification of data integrity and availability after every system change.

Sec. 13System changes controlled by change control with impact analysis.

Sec. 14Periodic review to confirm the system remains in a validated state.

How DROME complies

Pre-written IQ/OQ/PQ packages, audited version control, integrated change control and automated periodic reviews.

GAMP 5

Good Automated Manufacturing Practice

Category 4 documentation available

ISPE framework adopted by the European pharmaceutical industry for the development, validation and maintenance of computerised systems.

Category 4Configurable software requires configuration testing and a functional specification.

Category 5Custom software requires a full validated development lifecycle.

LifecycleManagement of the entire system lifecycle, including decommissioning.

Risk-basedValidation effort proportional to the risk to product quality.

How DROME complies

DROME qualifies as Category 4 (configurable software). Complete GAMP 5 documentation available, including functional specification and test protocols.

Ready to simplify your compliance?

The DROME platform was engineered to meet EU GMP Annex 11 and GDP Guidelines requirements from the architecture up, not as an afterthought.