Validation of laboratory information systems, full investigation, consulting
We can validate not only in pharmaceutical companies, but also in the lab information systems of chemical and food companies.
In Hungary, very few companies deal with the validation of laboratory IT systems, and even fewer companies provide services that examine the systems as fully as possible, give advice and prepare for various audits.
Organizations in the life sciences and health industries must meet the
requirements of Computerized System Validation (CSV) asked and required by
various pharmaceutical and state regulations.
The regulation requires companies in the life sciences industries to have specific control and quality assurance processes that consistently deliver results that meet predetermined specifications and quality characteristics.
Computer system validation (CSV) is the process of documenting that the computer system meets the specified system requirements and the regulations in force. By validating computer systems, it is possible to ensure the accuracy, reliability, robust and consistent operation of the system and the recognition of invalid or modified records.
WHO DO WE RECOMMEND OUR SERVICE TO?
We provide consultation to
the heads of IT quality assurance, validation and laboratory departments of
pharmaceutical, food and chemical companies, and we provide a full service to all elements of the laboratory information
technology system to be validated and to its projections.
We can validate not only in pharmaceutical companies, but also in the lab information systems of chemical and food companies. We carry out our validation activities independently with a high level of expertise.
We carry out validation activities even currently in large pharmaceutical companies.
HOW DOES 4iG HELP?
of computer systems,
- software validation
- MS Excel (personalized Excel development and validation)
- Enterprise Resource Planning (ERP) validation,
- 21 CFR Part 11 analysis and system remediation,
- Assessing the provision of data integrity,
- GxP risk assessment,
- CSV audit,
- Pharmaceutical audit preparation, consultation and support (CSV part).
Preparation for official inquisition (audit) in particular to the following organizations:
- National Institute of Pharmacy and Food Health (OGYÉI)
- European Medicines Agency (EMA)
- U.S. Food and Drug Administration (FDA)
Thanks to years of professional experience, 4iG takes a practical risk-based approach to the validation of computer systems and helps its customers comply with the increasingly stringent global regulatory requirements in all cases, minimizing the risk of GxP non-compliance. Our highly qualified consultants have the right skills, years of theoretical, professional, practical knowledge and experience in validating manufacturing and laboratory systems.