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Validation of computerized systems is required by many regulations, quality standards, and company policies. The intention of validation is to provide documented evidence and ensure that a specific system performs according to its specification.

Not only regulations like Good Manufacturing Practice (GMP) or Good Clinical Practices (GCP) require the industry to validate their computerized system, more and more companies realize the risks a flawed computerized system can mean for their business and require that critical applications are validated.

A key driver for validation in the pharmaceutical and medical device industry is FDA's enforcement of the FDA 21 CFR part 11, the regulation covering the use of electronic records and electronic signatures in regulated business processes.

• Business case and issues
• Capabilities and experiences of IBR AG
• Service and methodology
• Benefits of partnering with IBR AG

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Links of Interest:

• http://www.labcompliance.com
  Provides help to comply with regulations and quality standards in analytical laboratories with as little effort as possible, with highest confidence. Content is generally applicable to areas other than laboratories.
• http://www.ispe.org/gamp
  The GAMP Forum exists to promote the understanding of the regulation and use of automated systems within healthcare industries
• http://www.cr-csv.org
  CR-CSV working party addresses the needs of computer system validation in the clinical research