FDA cGMP/CSV Validation Service
 
Netorus FDA cGMP/CSV Consulting Service emphasizes on the critical aspects of the drug manufacturing (Process Validation, Laboratory Controls, OOS Investigations, Change Control, CAPA). The content of Netorus inspection forms are:
    • based on the regulation
      • 21CFR part 210 (General)
      • 21CFR part 211 (current Good Manufacturing Practice)
      • 21CFR part 11 (electronic and digital signature)
      • Q7A for Active Pharmaceutical Ingredients
    • Audited by correlation with FDA plant inspection report to cover all the critical steps of the drug manufacturing

Netorus Consulting Service is the best choice for the implementation of your quality system because we have implemented all the regulation in revolutionary software. Using Netorus cGMP ERP/MES/FCS system in collaboration with Netorus cGMP/CSV Consulting Service guarantee your company to pass the FDA inspection validation with success. Indeed, Netorus ERP/MES/FCS system is the first of its kind because:

-It implements the comprehensive guidance of the 21CFR parts 211, 210 for the good manufacturing practice of finished dosage, Q7A for the good manufacturing practice of API and comply with part 11 for the computer system requirements.

-It provides you, for the first time, with the controls to establish and maintain your production floor and your quality system in accordance to the regulation.