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

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

Advice Pharma is an Italian company that develops technologies and services for the management of data and information in the medical-scientific sector. The company mission is to develop and provide quality services, through the selection of the best technological and human resources.

TUV Certificazione

AdvicePharma has been certified UNI EN ISO 9001:2015 for the following scope: Design and development of information systems for collection and statistical processing of data of clinical and epidemiological trial in the pharmaceutical and biomedical field. Design and provision of consultancy services for clinical and epidemiological trials in the pharmaceutical and biomedical field. (IAF 33, 35)

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via Durando 38/a
20158 Milano Italy
c/o Polihub Politecnico di Milano

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Email info@advicepharma.com

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