Validation Quality Oversight

The Partnership

A large international firm which had FDA observational findings regarding validation of medical devices.

The Need

  • Perform review of all executed protocols to identify gaps.

  • Follow time parameters as committed to the FDA

  • Various skillsets were required ranging from equipment to processes

  • Coordinate with various onsite personnel in all departments

The Process

Missing or incorrect parameters were identified and corrected.

Establish Protocol For Review

Understanding of commitments obtained. Protocol established for review of executed validation packages.

Execution of Work Plan

Missing or incorrect parameters were identified and corrected.

Enhancement of Program

On-site procedures were enhanced to facilitate proper development and execution of validation activities.

Expansion of Duties

Exceeding client expectations, Compliance Insight was given the task to reformulate the cleaning program and validation

Completion of Project

All activities were executed within specified time frames and meeting FDA requirements.

Successful Results

All protocols were evaluated and enhanced to meet expectations. Cleaning program was developed and validation successfully executed. Subsequent FDA inspection directed at the project was successful.

Gain Our Insight