Medical Device Process validation
Medical Device Turnkey Project ConsultantOperon Strategist is a Leading regulatory & quality assurance consultant for Medical Device & primary packaging manufacturers. Working out of Pune, India, Operon Strategist has a global presence with an international client base.
Medical Device Plant Layout Design ConsultantWe are a leading service provider of facility plant setup, medical device unit design, pharma setup and clean room design facility plant setup services.
Medical Device Process ValidationProcess Validation For HVAC validation , Equipment validation , Process validation , Facilities validation , Cleaning validation , Analytical method validation.
Clean Room Design ConsultantClean room helps in Establishing & Maintaining an Environment with a low level of environmental pollutants such as dust, airborne microbes, aerosol particles & chemical vapors.
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.