Compliance Group Inc

Compliance Group Inc

Software Development

Libertyville, IL 18,302 followers

FDA Consortium Member and the Leading Provider of Validation & Quality Compliance Solutions

See jobs Follow

About us

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

Website
https://www.complianceg.com
Industry
Software Development
Company size
201-500 employees
Headquarters
Libertyville, IL
Type
Privately Held
Founded
2007
Specialties
Quality, Compliance, FDA Consortium, Audit & Inspection Remediation, SaaS and On-Premise Quality System implementations, Clinical Trial Development Support, Biostatistics, Data Analytics & Statistical Programming , Process Validation, Computer System Validation, Medical Device Validation, Cleaning Validation, 483, Consent Decree, Warning Letter Remediation, Audit Readiness Assessments, Data Integrity Assessment & Remediation, Serialization/UDI, Supplier Quality Audits, QMS Policies & Procedure Setup, Managed Services, Polarion, Siemens, FDA, and FDA Quality Metrics

Locations

Employees at Compliance Group Inc

See all employees

Updates

Affiliated pages

Similar pages

Browse jobs