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How to validate Software Development tools used for GXP?

Do, 08.02.2018, 09:00 (CET)
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Do, 08.02.2018, 17:00 (CET)
Anmeldeschluss: Do, 01.02.2018 (CET)
Milaneo Office CenterStuttgart, DeutschlandIn Google Maps öffnen
Freie Plätze: 4
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 TFS etc.

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.

SDLC tools are used for a wide range of applications. So such tools can even be used to build an eQMS including eDMS, CA/PA, deviation, OOS, training management system etc.

The idea behind that could be have all company processes and records managed by one single tool or platform.

And even better, such tools can be used to transfer the traditional qualification and validation approach based on paper to a real electronic validation platform.

This event will also focus on the regulatory requirements (GMP, GDP, GCP, GLP, GVP or MedDev), irrespective how you plan to use such tools - for software development, for records management, as validation tool or any other purpose.

This conference covers regulations, standards, examples and solutions.

Read more: Visit our microsite for information at https://radbeeqms.com/computer-system-validation-and-jira/

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.

SDLC tools are used for a wide range of applications. So such tools can even be used to build an eQMS including eDMS, CA/PA, deviation, OOS, training management system etc.

The idea behind that could be have all company processes and records managed by one single tool or platform.

And even better, such tools can be used to transfer the traditional qualification and validation approach based on paper to a real electronic validation platform.

This event will also focus on the regulatory requirements (GMP, GDP, GCP, GLP, GVP or MedDev), irrespective how you plan to use such tools - for software development, for records management, as validation tool or any other purpose.

This conference covers regulations, standards, examples and solutions.

Read more: Visit our microsite for information at https://radbeeqms.com/computer-system-validation-and-jira/

Programm


Programm and Speakers:

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


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