Developing IQVIA’s positions on key trends in the pharma and life sciences industries, with a focus on EMEA.
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Developing IQVIA’s positions on key trends in the pharma and life sciences industries, with a focus on EMEA.
Learn more
Developing IQVIA’s positions on key trends in the pharma and life sciences industries, with a focus on EMEA.
Learn more
Developing IQVIA’s positions on key trends in the pharma and life sciences industries, with a focus on EMEA.
Learn more
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SEARCH JOBSHow can pharma use CAPA as a tool to support continuous process improvement?
Corrective and Preventive Action (CAPA) is a systematic approach used by organizations to identify and address issues to ensure quality and regulatory compliance.
Pharmaceutical organizations, like all life sciences companies, need to be sure their CAPA process is effective. CAPA can only be used to support continuous improvement, and improve patient outcomes, if it analyzes causality to prevent reoccurrence.
Assessing risk
Organizations must prioritize CAPAs by focusing on the issues that have the most impact on patients, product quality and the organization overall. This means focusing on the highest risk issues first.
To measure risk, organizations must know what could happen or what did happen. Formal tools for defining the ‘what’ and performing risk assessments include but are not limited to:
Informal risk assessment methods include:
Collectively, these techniques are quality risk management tools that define not only what could or did happen (the problem) but also the risk involved with the potential or actual failures for a product or process. Understanding the problem is the first step in the continuous improvement process.
Determining root cause
Once we understand what has gone wrong, it is important to understand why an issue or issues occurred – you cannot correct an issue or prevent reoccurrence if the root cause hasn’t been determined.
Determining root cause involves performing a solid root cause analysis. Root cause analysis tools may include but are not limited to:
Choosing which root cause process is deployed within a company is dependent on the company’s products and organizational preferences.
Effectiveness review
An effectiveness review is a critical component of the CAPA process to determine whether the CAPA process has or has not been effective – has it eliminated the issue and prevented reoccurrence?
During an effectiveness review, an action plan will lay out the tasks needed to measure whether the CAPA has or has or has not eliminated the issue. The action plan should include qualitative and quantitative measures to determine effectiveness and should be clear, detailed and contain no ambiguity.
To ensure action innovation, it is important that CAPA doesn’t become a task assigned exclusively to the quality assurance team: making the process inclusive ensures that ideas from other disciplines within the organization can be considered and that everyone is aware of changes to be made.
Keeping CAPA fresh
CAPA is a process that can get stale if an organization is not paying attention. Assessing trends in CAPA effectiveness, monitoring root cause depth and accuracy, and assessing risk over time are key to achieving continuous improvement through the CAPA process.
The FDA calls out ineffective CAPA procedures and ineffective investigations often. While CAPA is a regulatory requirement, CAPA’s real value lies in its ability to support continuous process improvement, improving the efficacy, safety, and efficiency of pharma products, ultimately improving patient lives.
For information on how we can help with your CAPA processes download the factsheet and contact IQVIA today!
Meet the challenge of changing stakeholder demands and increasing cost constraints with IQVIA's integrated technology services and analytics-driven offerings.
From manufacturing oversight to regulatory requirements, manage quality across your organization with a single enterprise software solution.
Outdated compliance practices aren't viable amid evolving market and regulatory changes. IQVIA’s award-winning, end-to-end quality management system streamlines the product value chain, accelerates market entry, safeguards companies and patient safety, and meets complex regulatory demands.
IQVIA SmartSolve® Fundamentals is a cloud-based QMS for small biopharma companies. It automates CAPA, Deviation, Document, and Change Management to ensure compliance with minimal IT resources.
