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Validation / 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 FDA. Another well known code of practice is GAMP, which, although is not legally binding, is an acknowledged standard for validation.

Validation includes the provision of documented evidence that a system was 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.

Validation

ROTRONIC supports you in validating your monitoring system:

  • Development of SOP for system validation (CSV)
  • Preparation of project related validation plans and risk analysis
  • Preparation of IQ/OQ documents
  • Preparation of validation reports

Your benefits:

  • Competence directly from the manufacturer
  • Lower costs from efficient training
  • FDA/ GAMP-compliant systems

 

FDA: Food and Drug Administration, USA
GAMP: Good Automated Manufacturing Practice
CSV: Computer System Validation
SOP: Standard Operation Procedure
IQ/OQ: Installation Qualification / Operational Qualification