Compliance Group Inc

Industry: Software Development

Company Size: 201-500 employees

Founded: 2007

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