Medical Device Process Validation is a process of establishing documentary evidence demonstrating that a procedure, process or activity carried out in production maintains the desired level of compliance at all stages.
Operon Strategist guides manufacturers & Medical Device Process Validation service providers on the validation activity & documentation. We study the product & the production facility & accordingly design the validation master plan which outlines the validation activities to perform & timeline for the same.
We provide guidance for preparing validation protocols & reports in the correct format so as to meet the regulatory requirements including DQ, IQ, OQ & PQ protocols and PQ report.
Medical Device Process Validation services
Medical Device Process Validation is an important cGMP requirement & many regulatory agencies audit the validation documentation. Validation of a machine or a process is carried out to ensure that products of consistent quality are manufactured and the required level of compliance met at every stage. Since a wide variety of procedures, processes & activities need to validate; Medical Device Process Validation divided into the following sub-sections:
• HVAC validation
• Equipment validation
• Process validation
• Facilities validation
• Cleaning validation
• Analytical method validation
• Personnel validation
• Packaging validation
• Computer system validation
Being a medical device consultant, Operon Strategist guides manufacturers & medical device process validation service providers for the validation activity & documentation. The product and the production facility are studied to document the validation master plan according to which validation activities will perform as per the defined timeline.