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: email@example.com