Medical Device Process validation

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  • Medical Device Process Validation
    Medical Device Process Validation
    Process Validation For HVAC validation , Equipment validation , Process validation , Facilities validation , Cleaning validation , Analytical method validation.
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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. In particular, we provide the following validation services.

Validation is an important cGMP requirement & many regulatory agencies audit the validation documentation. Since a wide variety of procedures, processes & activities need to be validated.

Operon Strategist guides manufacturers & 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 be performed & 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 &; PQ report.

Medical Devices Validation services
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 required level of compliance is met at every stage. Since a wide variety of procedures, processes & activities need to be validated; validation is 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 & 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 be performed as per the defined timeline.

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