Month: June 2013

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GAMP 5 compliance – CMMI Version 1.3

According ISPE GAMP 5 – Page 11 – appropriate schemes for assessing and improving organization capability and maturity should be used, such as the Capability Maturity Model Integration (CMMI) for development. As such most companies which develop systems and software for the GxP related industry hold an ISO 9001 certification.

Download here the Version 1.3 of the current CMMI standard for development: DOWNLOAD DOC – CMMI_Dev-V1.3

Also a listing and mapping between ISO 9001 and CMMI can be downloaded here: DOWNLOAD PDF – CMMI_ISO-9000-2000-mapping

 

Contact us today for more information to GAMP compliant software and system development at: talk@comes-services.com

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Gute Vertriebspraxis GDP 2013/C 68/01 Leitlinie

Download the EU GDP Guideline here in German or English language.

Die überarbeitete Leitlinie tritt 6 Monaten nach der Veröffentlichung am 8. September 2013 in Kraft.

The guideline will enter into force in six months from the date of publication, on 8 September 2013.

 

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GAMP Training: GxP Process Control Systems

This new, highly interactive, course describes how the:

GAMP® Good Practice Guide: A Risk Based Approach to GxP  Process Control Systems

may be applied to achieve process control systems that are fit for intended use and meet current regulatory requirements. The course is executed by ISPE Europe in Prague – 7-8 October 2013.  READ MORE

Contact us for more information or possible in-house trainings and coaching by CCS at: talk@comes-services.com

 

 

 

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