Principi di Computer System Validation


L’evento avrà luogo il giorno 18 Febbraio 2020, dalle 8.30-18.00 in sala Arena in via Durando, 39 a Milano


Speaker: Dott. Francesco Abbate

  • Computer system validation general concepts
  • Validation Effort and Methodology – risk based approach – Client vs Supplier
  • Validation responsibility

2. Computer Validation Life Cycle

  • Validation lifecycle general scheme – Planning documents
  • Specification Documents
  • Testing Documents
  • Acceptance Documents

3. How to Maintain the Compliance Status

  • Change Management, control and methodologies
  • Periodic review, tools and methodologies
  • Periodic Maintenance of Computer System inventory
  • On-going procedures (Backup&Restore, Record Retention, Security, Use…)

4. ERES and Regulatory Requirements

  • Overview of Electronic Records and Electronic Signatures (ERES)
  • Different types of Electronic Record (input/output regulated/not regulated, permanent/not permanent)
  • Applicable Regulatory Requirements and System Configuration

5. Remediation Activities

  • Compliance Assessment methodology
  • User Rights Review
  • Examples of GAPs and Corrective Actions
  • Analysis of GAPs Solutions

6. Example of CSV approach applied to a real computerized system (e.g. ICE Advice Pharma)

For more info and details e-mail AdvicePharma at or call phone no. +390223992985

AdvicePharma is an Italian company that develops services and technologies for data and information management in the medical-scientific field. The company mission is to develop and provide quality services through the selection of the best technological and professional resources.

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Advice Pharma Group Srl is a UNI EN ISO 13485:2016 certified company for the provision of services for third parties for design, development and testing of standalone software medical devices intended for monitoring, diagnosis and therapy.

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Advice Pharma Group Srl is a UNI EN ISO 9001:2015 certified company
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via Durando 38 – 20158 Milano IT
c/o Polihub Politecnico di Milano

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