Operon 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 We are Provide Medical Device Turnkey Project Consulting Services In USA, Dubai, South Africa , New York , Qatar, Algeria, Libya, Shri lanka, Austrlia , Mauritius, Costa rica.Medical device manufacturers looking to set up new manufacturing unit can avail our turnkey project services. As medical device project consultants , we provide a complete package of turnkey services including layout design,clean room Design , validation, developing quality system, documentation, training & implementation services.
Medical Device Turnkey consultant include:
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:
• HVAC validation
• Equipment validation
• Process validation
• Facilities validation
• Cleaning validation
• Analytical method validation
• Personnel validation
• Packaging validation
• Computer system validation
• Equipment validation
• Process validation
• Facilities validation
• Cleaning validation
• Analytical method validation
• Personnel validation
• Packaging validation
• Computer system validation
if you have Required any assistance please
contact us Mail id: info@operonstrategist.com Website:http:www.operonstrategist.com
Contact No:+91-9823283428, +020-65283428
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