SAP QM-QN facilitates work flow process, task monitoring, solution database and FMEA process for handling complaints and CAPA processes. BUT the current fields and reports configuration do not support specific-requirements of regulatory/organization-.
What are the implications of of customizing the "fields", "work flow" and "reports" inline with the FDA requirements. i.e.,
1. huge number of fields have to added in the notification initiation section which are different for each CAPA process [complaint, deviation, incident]
2. multiple work flow process for each category of CAPA process.
3. multiple reporting requirements for each instance of CAPA record. etc.,
request your comments/guidance on the impact during the life cycle viz., "while upgrading the current versions to next level" etc.,
kindly enlighten.
venugopal.
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