Principi di Computer System Validation

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

WORKSHOP AGENDA

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 gehad.shehata@advicepharma.com 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.

TUV Certificazione
Advice Pharma Group Srl is a UNI EN ISO 9001:2015 certified company
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