SERV ICES
Validation Report
Validation Plan
(PQ)
Risk Management / Design Review Change Management Configuration Management
User Requirements Specification
(OQ)
Functional Specification
System Configuration Specification
(IQ)
Operation Qualification
Installation Qualification
Global companies are increasingly subject to obligatory international regulations. For example, manufacturers wishing to deliver pharmaceutical or food products to the USA must fulfill the requirements of the FDA1. Another well known code of practice is GAMP2, which, although is not legally binding, is an acknowledged standard for validation. Validation includes the provision of documented evidence that a system was
Implementation (Configuration)
Validation model
Performance Qualification
Validation
planned/produced according to quality guidelines, is tested against specifications and has been operated in a qualified manner since it was introduced. Missing information and poorly specified or inadequately tested systems represent a risk and can lead to high maintenance costs significant production losses and high costs. Validation by a computer-aided system (CSV3) is therefore critical for legal and business reasons. The latter are also valid for fields not subject to special legal regulations. Our products, including software, conform to specific FDA requirements, are manufactured according to GAMP and provide a path to validation. ROTRONIC supports you in validating your monitoring system: - Development of SOP4 for system validation (CSV) - Preparation of project related validation plans and risk analysis - Preparation of IQ/OQ5 documents - Preparation of validation reports
Your benefits: • Competence directly from the manufacturer • Lower costs from efficient training • FDA/ GAMP-compliant systems
FDA1:
Food and Drug Administration
GAMP2: Good Automated Manufacturing Practice CSV3:
Computer System Validation
SOP4:
148
Standard Operation Procedures
IQ/OQ : Installation/Operation Qualification 5