MEET CUSTOMER EXPECTATIONS – EVERY TIME
Customers of Life Sciences companies expect safe, effective, reliable, and trustworthy products. Adherence to GxP regulations not only ensures compliance but also enhances the quality and reliability of products – avoiding significant costs associated with product recalls, loss of trust and reputation, rework costs, and additional regulatory oversight.
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SaMD Audit Support | How to Address the Challenges SaMD?
Modern technology is always crucial to the advancement of the healthcare sector and the quality of healthcare provided to patients. Technology enables medicine to change, adapt, and advance, from the centuries-old discovery of tools like the magnifying glass and the stethoscope to more recent innovations like the CT scanner and the MRI.
IS YOUR COMPANY
INSPECTION/AUDIT READY?
Inspection readiness not only provides a degree of confidence internally but also ensures a seamless experience with the inspectors. Being “Inspection Ready” is equally important to both clinical-stage pharmaceutical companies and giant medical device corporations.
CG got us out of a difficult audit situation. They remediated 60+ systems in less than a year and streamlined our procedures and templates to align with the latest regulations. We had a successful follow-up inspection on those findings, and we have much better interdepartmental alignment. We continue to leverage CG services and highly recommend them.
– Head of IT Quality, Global Medical Product Company
CG’s holistic approach to inspection and audit
Pre-Inspection / Audit Readiness Assessments
Our experts conduct proactive Gap Assessments on identified process areas using established checklists that are pre-reviewed with the client. These areas may include, but are not limited to: QMS, IT QMS, Lab Controls, Manufacturing, Design Control, Clinical, Supplier Quality, etc. As part of the prework with the client, we develop risk ratings and remediation priority ratings.
Pre-Inspection Assessment Results & Remediation
Our experts review Gap Assessment results with the client and propose pragmatic, “right-sized” remediation efforts for updating SOPs and execution practices. These remediation activities are identified contextually with return on investment in mind.
Unannounced/Planned Inspection/Audit Support
Our experts help you navigate unannounced/planned inspections. This involves setting up audit control rooms, training and preparing key players on best practices, and sometimes defending the audit on behalf of the client.
Remediating Inspection Findings
If you have findings from regulatory/notified body inspections, there is no need to panic. Many times, an inspection finding is a necessary catalyst for change. We have remediated findings from 1,000+ inspections/audits and have all the toolkits necessary to deploy risk-based, effective corrective and preventive actions.