International
Pharmaceutical Company
Computer System Validation of an „Adverse Event Reporting Tool“ for Pharmacovigilance
- As part of a digitization initiative, the customer decided to replace the previously paper-based process for submitting side reactions resulting from patient support programs/market research programs as well as the reporting of spontaneous cases by employees of the company with an integrated IT system.
- A standard software was selected as the supporting IT system and subsequently implemented.
- The implemented IT system had to be validated according to current regulations.
- Categorizing the new IT system according to GAMP5 (Category 4 Configurable Software).
- Defining the validation strategy (risk based approach) according to market-based best practices and customer internal procedures and guidelines (Computer System Validation SOP’s).
- Preparing the validation documentation (validation plan, specifications, test plans, test reports, etc.).
- Managing and controlling the validation team (internal/external).
- Leading and monitoring all validation activities (IQ,OQ,PQ).
- Successful validation of the computer system with subsequent release for operational use/global roll-out.
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