Compliance Group Inc

Software DevelopmentIllinois, United States201-500 Employees

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

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