Core Services Test - IQS Consulting

Core Services

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”
eQMS expertise for installation and ongoing support

The transition and successful integration of an eQMS is an objective of many of our clients – large and small. Our partnership with Compliance Quest offers both out-of-the-box or tailored eQMS solutions which can be scaled to match the size and growth of your company.

Best in Class CAPA and Investigation Systems

One of the most common issues identified during FDA inspections is failure to investigate nonconformances and inadequate investigations. We work with clients to install a best-in-class investigations 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 recommendations are tailored to each company and include:

Investigation workflow and procedure gap assessment
Root cause analysis and CAPA training
Investigation triage
Investigator feedback and mentoring

Our goal is to ensure that your investigations are sufficiently in depth, commensurate with risk, identifying root cause (s) and the CAPAs selected are robust. What sets the IQS team apart is our thoroughness and desire to pass on what we have learned and experienced over the years investigating quality impacting issues in plant operations.

Continuous Quality System Assurance (CQSA™)

An expectation of FDA during site inspections (Pre-Approval Inspection or routine cGMP inspection) is evidence of a mature Pharmaceutical Quality System (PQS). During an 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 key quality systems and the quality of their QMS records. This is essential input to Management Review and will identify areas where improvement is required.

The benefits of CQSA™ include:

Inform of shifts in Quality System state of control
Identify potential systemic risks across a site network
Reduce compliance and business risk
Demonstrate continual improvement
Provide key input to Management Review

Compliance Quest customers can add CQSA™ (CQ’s Quality Maturity Index) as a dashboard metric to track and report on the state of QMS control.

Quality Risk Management Strategies for Manufacturing Site

Each manufacturing site manages compliance risks “known” to the operation. Our focus is to help manufacturing sites maximize the probability of identifying “unknown risks” associated with current processes, quality systems, and infrastructure. Our methodology is straightforward and an excellent indicator of a mature quality culture.

Furthermore, the application of Quality Risk Management (QRM) tools to support decision making during development and commercialization of drug products will range from informal to well-structured and well documented. We find that an unbiased and comprehensive review of QRM approaches at a manufacturing site or across a plant network is also an indicator of quality system maturity.

Our approach includes an assessment of existing Quality Risk Management and internal audit systems to optimize:

Alignment with ICH Q9 (R1) Quality Risk Management
Appropriate application of QRM tools
Risk register implementation and use
Internal audit program design and oversight
Internal (corporate) auditor training (see IQS Training)