• Validation Program which provide an industry standard approach based on the concepts of GHTF, ICH, GAMP, ISPE, and ISO to meet the expectations set forth in the Quality System Regulations.
• Development of Procedures that address other QSIT elements, including management controls, design controls, corrective and preventive actions, and production and process controls.
• Auditing of client Quality Management System, and or suppliers including audits of:
• Validation program (Governing documents such as production equipment qualification, facility qualification, process validation, cleaning validation, computer system validation, analytical equipment qualification and methods qualification).
  • Supplier assessments of new or current vendors.
  • Completed qualification and validation packages.
  • Design History File.
  • Change Control.
  • Batch Record Reviews.

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