Built to be validated under EU GMP Annex 11.
Documented data integrity, audit trails and access control, ready for inspection by the national competent authority.
DROME was designed around the requirements of EU GMP Annex 11 and the EU GDP Guidelines. Validation for your intended use stays with your team; DROME provides IQ/OQ/PQ documentation to support it.
Requirement by requirement.
Click each regulation to see how DROME addresses each requirement specifically.
EU GMP Annex 11Computerised Systems
Governs computerised systems used in activities covered by EU Good Manufacturing Practice (2011 version, currently in force).
IQ/OQ/PQ documentation to support your validation, an immutable audit trail, role-based access control and automated backup with a documented recovery SLA.
What does EU GMP Annex 11 require from a computerised system?
Annex 11 (2011) requires validation across the lifecycle (clause 4), secured data with verified backups (clause 7), an audit trail with the reason for each change (clause 9), access control (clause 12) and electronic signatures linked to the record (clause 14). DROME provides these controls and IQ/OQ/PQ documentation; validation belongs to the regulated user.
EU GDP GuidelinesGood Distribution Practice
European Commission guidelines (2013/C 343/01) on the distribution of medicinal products for human use, including temperature control during storage and transport.
Continuous monitoring, automatic temperature mapping, documented equipment qualification and integrated CAPA workflows.
What do the EU GDP Guidelines require on temperature?
The EU GDP Guidelines require temperature monitoring and records in storage, mapping of storage areas, qualified equipment, temperature control in transport and deviation management with CAPA. DROME monitors continuously, produces mapping reports and records every deviation.
EU GMP Annex 15Qualification & Validation
Sets requirements for qualifying facilities, equipment and utilities and for validating processes (2015 version).
Pre-written IQ/OQ/PQ protocols to support your qualification, audited version control, integrated change control and automated periodic reviews.
What does EU GMP Annex 15 require for qualification?
Annex 15 (2015) organizes qualification in stages (URS, DQ, IQ, OQ and PQ, section 3), requires periodic requalification (section 4) and change control (section 11). DROME supplies pre-written IQ/OQ/PQ protocols and records platform changes; execution and approval stay with the customer.
GAMP 5Good Automated Manufacturing Practice
ISPE framework adopted by the European pharmaceutical industry for the development, validation and maintenance of computerised systems.
DROME falls under Category 4 (configurable software). Documentation for this category is available, including the functional specification and test protocols.
Which GAMP 5 category does DROME fall under?
DROME is configurable software, which places it in GAMP 5 Category 4: configuration testing and a functional specification are expected. DROME supplies the functional specification and test protocols; the final classification comes from the customer's risk assessment.
Ready to simplify your compliance?
DROME was designed around the requirements of EU GMP Annex 11 and the EU GDP Guidelines. Validation for your intended use stays with your team; DROME provides IQ/OQ/PQ documentation to support it.