In the context of literature monitoring for adverse reactions to medicinal products (EMA GVP Module VI), a reasonable number of Market Authorization Holders have no ready answer to justify why they use each search formula for each specific product when Audit or Inspection time comes: in fact the search formula, responsible for all the inbound traffic in the Literature Monitoring process is, many times, not validated, or regularly reviewed. How does one create a “good” PV search formula for Literature Monitoring and validate it? By “good” we understand: a formula where you can justify, to an auditor or inspector, why do you use it instead of any other -one-.
In this webinar, I will discuss the process of (re-)validation of the search formulas used for literature monitoring in the context of EMA’s GVP Module VI. This will enable you to create and fine tune the search formula and, when needed, present evidence, to an auditor or inspector, on each search formula fitness for purpose.
Question on a LinkedIn group:
Life Science industry is using traditional V model for CSV. Should this model be changed for Agile based development, testing and validation.
I believe we should be able to use the user stories instead URS as the basis of V model. Please share your thought. Thanks
PJ Singh, PMP
Co-Founder & Director – Quality, Compliance, Validation, and Technology Integration
I’ve found out, during my tenure as Scrum PO for a GxP regulated product, that if you have a documentation resource, usually a Business Analyst, embedded in the SCRUM team, constantly making sure that there is documentation alignment between URS and User Stories, and make the documentation part of the Definition of Done, you can have a very strong alignment between V model and Agile practices.
I’m willing to propose and defend that, for implementing CSV while practicing Agile, one needs to have Documentation as a SPRINT deliverable.