QSR Services Page

Quality System Regulation (QSR) Support

Programs developed on the behalf of our customers have been successfully evaluated by client internal audits, FDA inspection and ISO certification/recertification audits. These programs have allowed our clients to transition from Official Action Indicated (USFDDA) to No Action Indicated (USFDA) on subsequent inspections.

  • 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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