Compliance doesn't have to be hard.Let Soliance Healthcare Solutions ("Soliance") create, implement, and maintain your Quality Management System. A "top-down" approach will be utilized to ensure your company meets all applicable regulatory requirements. Specializing in customer service, Soliance will bridge communication between internal and external customers, allowing for an enjoyable, painless process for things like internal audits, Root Cause Analysis/CAPA Management, and Continuous Improvements.Soliance can help create a robust internal audit schedule for your company, ensuring compliant systems are in place. If needed, Soliance can also perform audits remotely/in-person.Soliance can help with your Supplier Evaluation/Qualification processes. From Supplier Questionnaires to on-site inspections, Soliance has the experience and tools to ensure your critical suppliers are appropriately evaluated and approved for your Approved Vendor List (AVL).CLIA certified/CAP accredited clinical laboratories looking for guidance on training/competency assessments, proficiency testing, instrument and method comparabilities, state licensure, internal audits, Equipment Maintenance/PMs, or CAPA Management should look no further. Coming soon: A full suite of regulatory submission services including NDA, BLA, 510k, PMA etc.Jenna Chicoine, Owner and Principal Consultant, has 12+ years of industry experience; including food manufacturing, pre-clinical ecotoxicology testing, medical device, IVD medical device, pharmaceuticals, and clinical diagnostics. She holds an ASQ CQA (Certified Quality Auditor) certificate, an ISO 13485:2016 Lead Auditor certificate, a graduate certificate in Biopharmaceutical Regulatory Affairs, a Bachelor of Science in Biology, and a Master of Science in Regulatory Affairs. During her down time, she enjoys exploring new places, trying new food, attending MeetUps, biking, hiking, and kayaking.
Social Link - Linkedin: http://www.linkedin.com/company/soliance-healthcare-solutions-llc
Employee Count: 1
Keywords: medical