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Computer System Validation

Pharma / Computer System Validation

Validated computer systems fulfil the set requirements reliably and comprehensibly.

AVANTALION Services

We support you in planning and conducting computer system validations (CSV) based on GAMPĀ®5 guidelines. We clarify the vital factors in CSV in the context of your specific systems and applications. We support you with the appropriate selection and efficient utilization of approaches, methods and tools.

We are always well-informed about current trends by actively participating in various task forces, such as the GAMP D-A-CH (Germany, Austria and Switzerland) forum and contribute to the further development of procedures and methods.

With AVANTALION, your computer-assisted systems are validated according to state of the art technology and your investment in IT is balanced with the benefits achieved.

The building blocks of Computer System Validation

Planning & Preparing CSV

  • Requirement conform procedures
  • Careful validation

Staff qualification

  • Trainings
  • Role models
  • Job descriptions

IT-Risk Management

  • Identification of GxP criticality
  • Risk and impact analysis
  • Suitable procedures and methods

IT-Infrastructure Qualification

  • Verification of system capabilities
  • Risk-based infrastructure analysis
  • Conception of IT platforms

Specification and Verification

  • Comprehension of processes
  • Requirements specification
  • Risk-based test management

IT-Quality Management

  • Work instructions/ SOPs
  • IT operating processes

Management of Suppliers

  • Supplier audit
  • Control of suppliers
  • Communication processes

Regulatory Compliance

  • Country-specific legal bases
  • CSV based on GAMPĀ®5 guidline

Contact Pharma / Computer System Validation

Andreas Gehricke

Andreas Gehricke

+49 30 257 607 - 52

andreas.gehricke@avantalion.de

Overview Pharma