Computer system validation and Jira


How to validate software development tools used for GXP and MedDev?

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) or others (Redmine, TFS, etc.). 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, case studies, examples and solutions.

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, ott+partner and Microsoft Silver Partner)

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, Ambassador ISPE DACH)

Making JIRA and Confluence GXP-ready

(Mrs. Rina Nir, Atlassian Solution Partner)

For More Information

Join us on the 8.2.2018 in Stuttgart, Germany
How to validate software development tools used for GXP and MedDev?

To register

Conference location

How you can find us:

Wolfram Ott & Partner GmbH
Heilbronner Straße 74
70191 Stuttgart

If you need help or want some special information about this event, please contact us: +49 (711) 184243 - 0

By walk from Celtral Station
10 Minutes

By Subway
Lines U5, U6, U7, U15 – Station Stadtbibliothek (Milaneo)
Line U12 – Station Budapester Platz (Milaneo)

By car
B27, Heilbronner Straße (Navigation: Wolframstraße 35, 70191 Stuttgart)

Ort: Stuttgart / Office MILANEO / Heilbronner Straße 74