Compliance Group Inc

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

Company’s Keywords:

quality, compliance, fda consortium, onsite, offshore delivery, audit, inspection remediation, saas & onpremise 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, staffing, managed services, polarion, siemens, fda, fda quality metrics