The Importance of CAPA in
Quality Management Systems

Corrective and Preventative Action (CAPA) is a concept within the Food and Drug Administration’s (FDA) Good Manufacturing Practice (GMP). CAPA involves the systematic analysis of anomalies, defects, or inconsistencies in an attempt to prevent their recurrence. It is an elaborate system of processes used to ensure conformity with several U.S. laws and quality standards.

Without fail, CAPA systems are a focal point for FDA inspections, and quality system audits every year. The FDA continues to clamp down on food and beverage manufacturers with rigorous compliance, safety, and quality regulations. A comprehensive, well-documented, and implemented CAPA can make all the difference when it comes to compliance.

There’s a common misconception that CAPA systems are difficult to understand and implement. Let’s lay this misconception to rest. Here’s everything you need to know about CAPA to ready your business.

Understanding CAPA

As mentioned, CAPAs are actions that correct, prevent and eliminate the recurrence of poor quality and are an essential tool in eliminating causes of non-conformities in manufacturing processes. As a result, CAPAs are an integral part of change control, risk management, and continuous improvement.

  • CAPA is split into two distinct but related functions that are often misunderstood.
    Corrective action is taken to eliminate a non-conformity or any other undesirable event that poses a quality risk. The goal of corrective action is to find the root cause of a problem and correct it. Therefore, action is taken after a failure occurs.
  • A preventative action averts the occurrence of a nonconformity either through effective corrective action or through continuous risk management that identifies, eliminates, and reduces the occurrence of issues that could result in poor quality.

As a CAPA system evolves, it advances from more corrective actions to preventative actions. In the long haul, preventing quality issues saves time and money as there is progressively less need for rework.

Importance of CAPA in Quality Management Systems

CAPA systems are designed to simplify FDA regulatory requirements for corrective and preventative action processes.

Implementing CAPA in Quality Management Systems (QMS) simplifies the process of complying with FDA requirements. It provides a safeguard against regulatory risk by integrating with QMS systems for audits, non-conformances, and change control.

To ensure FDA compliance, manufacturers must ensure that their CAPA system can demonstrate the effectiveness of their quality system. A true CAPA system enables the identification of defects and problems as well as the implementation of effective and preventive actions.

A fundamental aspect of quality management is continuous improvement. A sound CAPA system ensures this by handling non-conformances quickly and efficiently, in addition to preventing future errors.

  • A good CAPA system should be able to do the following:
    Include CAPA procedures that address quality requirements
  • Identify non-conformances and facilitate data analysis focusing on the root causes of product quality concerns
  • Enable visualization and reporting of quality performance analytics
  • Integrate with compliance, audit, and training management systems
  • Enable users to monitor trends for preventative action
  • Facilitate the statistical analysis of failures and discrepancies
  • Allow users to validate the success of corrective and preventive actions

Regardless of industry or the size of your company, you should implement CAPA software systems as part of your quality management system if you want to reduce business risks and improve quality levels.

CAPA programs are most effective when they are approached and utilized as proactive systems as opposed to reactive ones. The benefits of this approach include:

  • Assurance that quality issues are resolved
  • Reduced rework and scrap numbers
  • Compliance requirements are met
  • Reduced customer complaints
  • A streamlined procedure for problem-solving

The Fundamentals of the CAPA Quality Process

To make the most of your CAPA system, you require an intimate understanding of the CAPA quality process.

Some organizations perceive CAPA as an onerous task they must complete to stay compliant. Well, this isn’t the best view. You should approach CAPA as a complete system made up of phases. A lifecycle program, if you will. One that provides the tools to identify and investigate a discrepancy and evaluate the effectiveness of a resolution.

CAPA Quality Management Process

The following phase-based system provides a systematic approach to quality management.

  1. Detection – Identify the problem with a complete description of who, what, when, why, and how. It can also involve a risk analysis.
  2. Evaluation and Investigation – Determine the extent of the failure and its probable impact, and the actions necessary to mitigate the risk. Moreover, determine the root cause of the problem using end-to-end traceability.
  3. Proposed corrections – This phase includes the evaluation of corrective actions and containment measures. The action plan should proactively identify the broader issue in case field correction or recall is necessary.
  4. Implementation – Eliminate the cause of non-conformity through long-term corrective and preventative action.
  5. Effectiveness Check – Validate the effectiveness of the corrective and preventative actions to ensure that the measures are appropriate for the root cause and prevent future events.

A phase-based approach to CAPA ensures events are dealt with promptly and the implemented actions are efficient.

Don’t Be Caught Off Guard – Implement CAPA

A robust automated CAPA system is the key to regulatory compliance and fast action on complaints. CAPA enables you to establish information loops to manage and correct errors and incidents. It’s essential to have a system that allows you to safeguard consumer confidence and certify compliance while protecting your bottom line.

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Heidi Krueger

Head of Quality Assurance

Heidi leads Xybion’s Quality Assurance practice. She has over 20 years’ experience in designing and implementing quality assurance policies. Since joining Xybion in 2000, Heidi worked with several clients to design quality policies and ensure compliance. She is responsible to hosting Xybion customer audits. Heidi has a BA degree in Biology from The King’s College.

James Castonguay

Product Technology Lead

James provides leadership to Xybion quality management systems including product design, development and client delivery. James started working with Xybion in 2002 in its Canadian division. He is now managing product delivery from the United States. James has a master’s degree in mathematics and minor in informatics from the University of Sherbrook, Quebec, Canada.

Dave Chiaramonte

Enterprise Assets and HSE Leader
Dave brings diverse and deep expertise to his leadership role as the leader of Enterprise Asset Management (EAM) and Employee Health & Safety line of business. Dave has over twenty years of experience within the Information Technology industry including development, implementation and integration of complex Enterprise Systems in large corporate environments. He is a highly regarded technology leader in IBM’s Maximo Asset Management Product implementation. Dave worked with BMS and Dupont pharmaceuticals before joining Xybion in 2004.

Tom Klapmuts

Digital Lab Solution Leader

Tom provides leadership in design, delivery and revenue growth of Xybion digital lab solutions. He is an experienced client solutions manager with a demonstrated history of working with many clients globally to solve their business problems. Tom has training in U.S. Food and Drug Administration (FDA), Good Laboratory Practice (GLP), Life Sciences, CRO Management, and Clinical Development. Before joining Xybion, Tom worked for pharmaceutical companies such as Merck and Schering Plough. Tom is a Purdue university alumnus.

Priya Rajesh

Head of Sales: APAC & EMEA

Priya is responsible for Xybion business growth in APAC and EMEA region. She brings over 18 years of experience in Business Consulting and Operations Management. Her deep expertise in diversified areas, including strategic alliance and partnership management, diversity and inclusivity initiatives and employee development, will amplify Xybion’s global strategic relationships and will strengthen the company’s executive leadership in India. In her last role at Conduent, she served as Director-Marketing & Bid Management. Prior to this, Priya has worked with Infosys and Covansys (now CSC). Priya holds degrees in microbiology & health management.

Raji Bijur

Head of Quality Control & CSV

Raji leads Xybion Quality Control function. She has over 22 years of experience in software quality management, CSV, SQA, software process & KPI development and industry benchmarking. She has strong process implementation knowledge including ISO, CMMI, Agile, Scrum, Six Sigma, Lean. Certified CSQA, CSV, GCP, and GAMP. Raji has led implementation of QC processes in Robotic Process Automation (RPA) projects. Before coming to Xybion in 2019, she worked with IQVIA (Former Quintiles), Infosys, Aris Global, Mphasis and serving clients across different market segments. Raji has a bachelor’s degree in information science & technology and MBA from Indian Institute of Management, Ahmedabad.

Bob Friedman

Chief Solution Architect

Bob Friedman has over 25 years of experience in Preclinical information systems at Xybion Corporation as a developer, development manager and Chief Solution Architect. He has been an active member of the CDISC SEND standards consortium for five years as well as the PhUSE / FDA Industry Collaboration. Bob has previously worked for Synthes Orthopedics, NYU Medical Center and the New York State Department of Health. He has a master’s degree in Biomedical Engineering from Rensselaer Polytechnic Institute.

Gokul Panda

Head of Platform and Product Development

Gokul is the Head of Platform and Product Development, responsible for developing new and critical platforms and products. He has over 20 years of enterprise software development in the life sciences industry and related fields. Gokul holds both a Bachelor’s Degree and Master’s Degree in Engineering from the Indian Institute of Engineering, Science, and Technology. Gokul’s unrivaled expertise in enterprise software architecture and solutions provides Xybion’s clients with leading product functionality, innovation, and platform stability.

Anu Roy

Chief Solutions Delivery Officer

Anu manages project delivery and relationship. She has over 18 years of Life Sciences industry and IT services experience. Anu has a strong track record of designing and developing digital solutions, management consulting, quality & compliance Management, CLM, process & key metrics design, program execution & improvement and account management. Anu is a recipient of the STEM WOC ‘Technology Rising Star ‘by US Women’s magazine in 2014. She has received several other awards including Infosys Consulting Architect Award for outstanding achievement in 2011, RCL Crown Golden Brain Award in 2013. Anu is a guest columnist at Pharmaceutical Compliance Monitor and published in several international business magazines. Anu has a bachelor’s degree in Biochemistry and MBA in marketing.

Keith Dempsey

Chief Information Officer

Keith Dempsey has joined Xybion as our global CIO. He brings 20+ years of progressive Information Technology experience from Merck, AIG, Barclays and PriceWaterhouse. Focusing his career on building global strategies that capitalize on progressive technologies that scale in accordance to realized business growth. His experiences range from introducing new technologies that facilitated a competitive advantage for Merck, introduced new and scalable technologies for AIG Investments, and created progressive global organizational improvements for Barclay’s Capital. Keith has a degree in Chemical Engineering from Clarkson University and an MBA from William Paterson University.

Steve Porfano

Executive Vice President & Chief Financial Officer

Steve manages Xybion corporate function which includes Finance, HR, Legal and QA. Steve joined Xybion in 1989 as Corporate Controller and was promoted to Chief Financial Officer in 1991. As Chief Financial Officer, Steve is responsible for the establishment, enhancement, coordination and administration of the Company’s financial systems, internal controls, and related areas. Additionally, he is the corporate liaison to the Company’s bank, independent certified public accounting firm and governmental compliance and financial auditors.

Kamal Biswas

President & Chief Operating Officer

Kamal joined Xybion as its President and Chief Operating Officer in 2018. He is an acknowledged leader in the life sciences industry and has over 20 years’ experience in management consulting and pharmaceutical business. Very recently, Kamal was a Partner and leader of the global Life Sciences practice at Infosys Consulting. Before that, he spent several years working with pharma companies including Novartis Pharma and Ciba Geigy to manage manufacturing and late-stage R&D functions.

Pradip K. Banerjee, Ph.D., MBA

Chairman of the Board & Chief Executive Officer

Dr. Banerjee is an entrepreneurial senior executive with 30+ years of in-depth experience in the global Life Sciences, Healthcare and Services industry in global operations, strategic management, business development, investments and new ventures creation, M&A and Buy-outs. Prior to acquiring Xybion in 2008, Pradip served as President and CEO of Science Center in Philadelphia focused on creating, incubating, managing and investing in science based new companies. He was the Partner-in-Charge of the pharmaceutical Research & Development unit of Accenture where he created the R&D consulting unit and had grown it to become $100+ million worldwide business. Dr. Banerjee holds a Ph.D. in Pharmaceutical Sciences from University of Wisconsin-Madison and an MBA from the Wharton Business School of University of Pennsylvania.

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