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.