Core Services
Continuous Quality System Assurance (CQSA)
An expectation of FDA during site inspection (Pre-Approval Inspection or routine cGMP inspection) is evidence of a mature Pharmaceutical Quality System (PQS). During the inspection, FDA investigators will evaluate the processes for continual quality system improvement.
The CQSA framework will provide a company with ongoing feedback concerning the health of their quality systems. This is essential input to Management Review and will identify areas where improvement is required.
The benefits of CQSA include:
- Maintain a state of inspection readiness
- Avoid systemic risks across a network of sites
- Reduce compliance and business risk
- Demonstrate continual improvement
- Provide a key input to Management Review
Quality Management System (QMS) Installation or Remediation
We have seen nearly every flavor of a Quality Management System, and a wide variety of workflows for change control, deviations, complaints, etc. Projects often involve the reengineering of an existing QMS or targeted improvement of QMS elements such as Change Control and CAPA.
The benefits of the IQS Consulting approach include:
- A QMS that is tailored to your company
- A QMS that is efficient and effective
- Roadmap to a mature Quality System
- Aligned with the expectations of FDA’s “PQS assessor”
- Remediate QMS elements to ensure “no weak QMS links”
Best in Class CAPA and Investigation Systems
One of the most common issues identified during FDA inspections is failure to investigate discrepancies and inadequate investigations. We work with clients to install a best-in-class program to minimize the risk of regulatory observations in this area. While there is no “one size fits all” approach, there are many actions companies can take to improve their investigation systems.
Our program recommendations are tailored to each company and can include:
- Investigation workflow improvement and supporting procedures
- Root Cause Analysis and CAPA Training
- Oversight and Governance recommendations
- Investigator Mentoring
- Activating Ways of Working (WOW) Principles