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This SOP group describes procedures necessary for a compliant Quality System including how to plan for a FDA audit and respond to 483's and warning letters.
These SOP's describe procedures for compliant control of documents including laboratory notebooks and partner company documents.
This SOP group contains procedures for the control of software development and validation including off the shelf software and 21 CFR part 11 validation.
These SOP's describe procedures to control incoming material including control of nonconforming product.
This SOP group contains procedures that will assure that your medical device product development work is conducted in conformance with FDA/ISO requirements including verification and validation.
This SOP group comprises a compliant CAPA program including SOP's for recalls, MDR's and post distribution product monitoring.
This SOP group contains procedures for a compliant risk management program including Hazard Analysis following ISO14971, FMEA and critical manufacturing operations analysis.
These SOP's describe a compliant process validation program from FAT through IQ,OQ and PQ. Validation deviation handling is included.
This SOP group will allow you to create a compliant program following ISO62366 and the 2016 FDA guidance.
This SOP group describes procedures for controlling purchasing and vendor/ contract manufacurer activities including audits and control of changes traveling between company and vendor.