Events 2018: How to validate Software Development tools used for GXP and MedDev?

8 February 2018, Stuttgart, Germany (9 am to 5 pm)

Venue: Milaneo Office Center, Heilbronner Straße 74, Stuttgart, Germany

The programme will focus on regulated companies that are in the process of the implementation and validation of software development tools like JIRA, BitBucket and Confluence (Atlassian). If such tools are used for GXP activities (GMP, GLP, GDP, GVP, GCP) or medical devices (MedDev) these must comply with regulations like 21 CFR Part 211, Part 820, Part 11 or EMA EudraLex Vol. 4 – Annex 11.

Several standards and guidelines might be applied to the design of the software development lifecycle (SDLC) and the validation of software, like ISPE GAMP, ISO 12207, IEC 62304, CMMI and AAMI TIR45:2012.

This conference covers regulations, standards, examples and solutions!

The event can also be found on XING Event Plus – OPEN LINK.

Register online here.

  • Regulations and Standards – GXP & SDLC vs. GAMP 5 (Mr. Markus Roemer, Ambassador ISPE DACH)
  • Using JIRA and Confluence as eQMS (Mrs. Rina Nir, Atlassian Solution Partner)
  • Using CMMI and Scrum: SW development for GMP products and supplier audits (Mr. Stellan Ott)
  • GXP cloud solutions and software deployment (Mr. Keith Williams, Member of ISPE GAMP European Committee)
  • Using Confluence as eValidation Tool – example for a GAMP category 5 application for GVP  (Mr. Markus Roemer)
  • Making JIRA and Confluence GXP-ready (Mrs. Rina Nir)