Arcondis

CSV (Computer System Validation) Training Services

Your company supports and uses new GxP-related applications. The staff must be given training in order to raise awareness of the importance of quality in observing legal regulations. Arcondis offers you the opportunity to develop staff awareness and GxP compliance using targeted training courses. In order to ensure that your company’s processes and quality management procedures are compatible with the CSV approach described in the course, we incorporate individual requirements in our basic CSV course, following an evaluation of your QMS/SOP documentation. In addition, we offer individually adapted, constructive workshops covering special CSV topics. Our training courses also include preparation for audits/inspections and role plays of behaviour during audits.

Starting point

  • Training employees in computer system validations

  • Greater awareness of validation is needed

  • An inspection is about to start

  • Developing an internal validation function

  • Managing and creating applications in a regulated environment

  • Understanding the regulations issued by health authorities relating to software and hardware maintenance

Our contribution

  • Basic CSV training in order to raise awareness

  • Customised CSV training courses

  • A selection of special topics including the creation of template frameworks

  • More in-depth CSV and best practice workshops

  • Developing validation expertise within your company

  • Transfer of our extensive knowledge and experience

Your benefit

  • Development of internal CSV expertise

  • Meeting regulatory requirements for training

  • Optimum preparation for audits and inspections

  • CSV expertise increases awareness of quality in day-to-day work

  • Capability to run validation projects independently

  • Reduced fear of inspections

NewsFlash April 2012

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