• Contact
  • Privacy Policy
  • Imprint
Telefon/Phone: +49 (0)221 / 27645982
SCALA Management Consulting
  • Home
  • About us
    • Short Profile
    • Management Team
    • Advisory Approach
    • Network
  • Competences
    • Processes & Organization
    • Program & Project Management
    • IT Architeture & Platforms
  • Industries
    • Financial Services
    • Pharma/HealthCare
    • Telecommunications
  • Career
    • Senior Consultant
    • Consultant
  • Contact
    • Privacy Policy
    • Imprint
  • News
  • Deutsch
  • English
  • Search
  • Menu Menu
  • International
    Pharmaceutical Company

Pharmacovigilance

n.a.

Employees

Team SCALA

2

Consultants

Time Period

2,5

Months

Computer System Validation of an „Adverse Event Reporting Tool“ for Pharmacovigilance

Starting Point

  • 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.

Approach

  • 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).

Deliverables/Benefits

  • Successful validation of the computer system with subsequent release for operational use/global roll-out.

More project references

  • Developing a Process Model according to BPMN 2.0 Standard in Clinical Development22. March 2021 - 1:34
  • Developing a flexible and cross-functional Business Data Model in Clinical Operations20. March 2021 - 19:58
  • FT2E® (Analysis & Design) in the Corporate Communication Department (Interface: M&A/Corporate Finance)27. March 2021 - 10:59
  • Transforming Standard Operating Procedures (SOP’s) of Regulatory Affairs into Process Flows according to BPMN 2.0 Standard22. March 2021 - 1:10
  • Optimizing the Clinical Development Business Process Model and transfer to a web-based Solution20. March 2021 - 19:54
  • Analyzing Business Processes and IT Systems in the Global Medical Affairs Department22. March 2021 - 1:11

Our office in Cologne

SCALA Management Consulting GmbH & Co KG
EuroNova III
Zollstockgürtel 61
D-50969 Köln
n: +49 (0)221 / 27 64 59 82
x: +49 (0)221 / 27 64 59 83

Legal

  • Privacy Policy
  • Imprint

LAST PROJECTS

  • Developing a Process Model according to BPMN 2.0 Standard in Clinical Development22. March 2021 - 1:34
  • Developing a flexible and cross-functional Business Data Model in Clinical Operations20. March 2021 - 19:58
  • FT2E® (Analysis & Design) in the Corporate Communication Department (Interface: M&A/Corporate Finance)27. March 2021 - 10:59

Recent Posts

  • Relaunch Webseite
  • SCALA is cooking
  • SCALA donates sleeping bags for the homeless in Berlin, Frankfurt am Main and Cologne
© Copyright - SCALA Management Consulting
  • Privacy Policy
  • Imprint
Developing a “Digital World of Experience” for Financial Derivatives...
Scroll to top
Consent Management Platform by Real Cookie Banner