Amy Hanak's Contact Details

Amy Hanak's Company Details

Compliance Group Inc

Chicago, Illinois, United States • 201 - 500 Employees
Medical Devices

Compliance Group is a Quality Compliance solutions provider based in Illinois, US with offices in NJ, the UK and India. Compliance Group's motto is to provide "right-sized" compliance solutions. Compliance Group is the only service provider organization in FDA consortium. This FDA & Industry consortium is coming up with a paradigm shift in validation guidance for the industry. This knowledge & expertise has resulted in significant capital and operational savings for our clients. Compliance Group is also a Siemens Solution Partner in ALM space. With automation at the center of it's services, onsite/near-shore/offshore service delivery models, and presence in US/EU & India, Compliance Group has proven expertise supporting customers with the following:- Quality Data Analytics compatible to FDA Quality Metrics program- Hands-free Process Validation, Training, Design Transfer and DHF Support documentation using "Smart Glasses"​- On-Premise or SaaS Quality System offerings - Setting up QMS and SQA policies - Center of Excellence (CoE) - Setting up and running CoE models using Onsite/Offshore delivery models- Support with Computer System Validation, Process Validation, Equipment Validation, Cleaning Validation, Medical Device product validation & Quality Engineering (CAPAs, NCRs, Complaints, Supplier Quality execution)- Audit/Inspection Readiness Assessments – If there is an impending Internal Audit or an External Regulatory Agency Inspection, we can perform Audit Readiness Assessments and deliver prioritized remediation activities- Supplier Quality Audits – Our certified Auditors can perform Supplier Quality audits and provide intelligence on Supplier Quality.- Remediation Packages – Packages to address Consent Decrees, 483s, Warning Letters and Data Integrity Issues- Process Improvement Packages - Serialization/UDI - Setup & end to end line validation/compliance