Corrective & Preventive Actions – Closing the Loop

Introduction

Implementing effective and comprehensive CAPA in a timely manner continues to be a major problem among medical device, pharmaceutical, and biological companies. The lack of follow-up and close-out are frequently mentioned. According to recent trends, approximately 30% to 50% of all citations are CAPA-related. Manufacturers following ISO quality standards must also ensure appropriate corrective and preventive actions are done to sustain quality and promote improvement within the organization.

To ensure compliance and quality, organizations must close the loop on risk and non-compliance and develop closed-loop systems that detect existing potential quality problems and facilitate rapid problem resolution and closure. While all organizations hope to avoid the root causes that necessitate corrective actions, reality dictates otherwise. Because defects, deviations, or any other gaps that trigger the need for a CAPA can come from a myriad of sources (documents, training, products, etc.), CAPA management has become the core process of a well-established compliance and quality program.

The automation of CAPA coupled with a multinational CAPA team ensures complete visibility when deviations, potential discrepancies, or non-conformances are discovered. As depicted in the figure below, CAPA is central to the implementation of an effective, closed-loop, continuous improvement process that focuses on prevention and quality.

Principles of Closed Loop Compliance

Figure 1 – Closed-loop compliance process control system

A well-established CAPA management automated system should include the following key features to ensure compliance and quality:

  • Powerful, configurable workflow engine for the management of proactive and reactive events
  • Integrated document/content management
  • Enterprise collaboration
  • Integration with modules that support non-conformance, audit management, change control, incident, customer complaint, deviation, out-of-specification results, and any other reactive quality processes
  • Custom report generation
  • Electronic forms integration to ensure adaptability within specific organizations
  • 21 CFR Part 11 electronic Signature Capabilities
  • Search and retrieval
  • Statistical and graphical trend analysis and visualization
  • Flexible custom report generation
  • Documented API’s for interoperability with other enterprise technologies such as ERP, LIMS, and ERP

Integrated CAPA Management Systems Best Practices

The following current best practices are designed to help mitigate risk and holistically drive quality across today’s regulated organizations. The industry is evolving from the deployment of standalone CAPA systems to integrated compliance process control systems that treat CAPA as an integrated enterprise process. The following best practices are an excellent starting point to help avoid implementation problems and regulatory issues.

  1. Establish an enterprise-wide CAPA program. Management of CAPA impacts multiple areas of the organization. It requires orchestrated coordination of activities and collaboration across the global enterprise through the complete CAPA lifecycle. A current best practice is to develop CAPA systems as a strategic initiative versus a departmental project. This ensures effective monitoring and control of all CAPA incidents across the organization and facilitates aggregated management control.
  1. Ensure top-down management support. Enterprise initiatives require support from the very top of the organization to ensure that resources are allocated appropriately, and policy is consistently managed across the organization. It is a highly recommended best practice that a cross-functional team is established with an executive champion who has the authority to specify corporate policy with respect to CAPA.
  1. Enterprise collaboration. An important current best practice designed to improve operational efficiency leverages integrated collaboration technology to facilitate the sharing of quality and CAPA knowledge across the entire enterprise.
  1. Ensure compliance with 21 CFR Part 11. It is common best practice to develop all CAPA systems in compliance with 21 CFR Part 11 requirements. Since CAPA is inextricably linked to other automated quality processes, a consistent approach to 21 CFR Part 11 must be adopted across all quality systems. Remember, Part 11 provides governance for electronic records and signatures–not just electronic signatures.
  1. Incorporate training and competency management as part of the global solution. A recommended best practice is to train and manage the competencies of all technical and business users that manage or use the integrated CAPA system. Leverage triggers of the CAPA system to track and manage training scheduled requirements in support of current regulations.
  1. Do not over-customize. Over-customization is the single biggest factor in increasing costs. Amadeus delivers an effective solution for the management of corrective and preventive actions that adheres to the best practices included herein. Where practical, leverage off-the-shelf technology.
  1. Establish effective written procedures prior to automation. Many times, regulated companies tend to automate bad processes. This is often the case when technology is purchased in advance of planning. It is current best practice to have effective written policies and procedures in place for CAPA governance that are consistently communicated across the enterprise. These procedures should be examined and streamlined prior to mapping them to automated systems. Effective manual procedures may make poor automated procedures. Automation most often helps streamline processes and may result in the elimination of steps that may be appropriate in the manual world but are unnecessary in the world of automation. For example, it is common for most CAPA procedures to include the gathering of supporting information during the investigation phase. In the manual process, this information is collected from file cabinets, duplicated, and distributed through corporate mail systems (not email). In the automated world, the duplication and distribution through mail (not email) systems is eliminated due to electronic systems capability.
  1. Develop a migration strategy upfront. This is the most overlooked step in many compliance initiatives.
  1. Validate the integrated system. It is current best practice to validate all integrated quality systems. CAPA systems fall into this category. Validation ensures system integrity and repeatable results throughout the CAPA process. It is important to establish a set of user requirements for the system so that all validation activities can be performed in accordance with the intended use.
  1. Establish compliance intelligence. Compliance intelligence is the integration of compliance process control systems and business intelligence systems. The integration of the two technologies forms a unique compliance intelligence system that allows management to carry out its management control obligations as stipulated by 21 CFR 820.100. Current CAPA regulations require management to provide oversight and governance throughout the entire process and across the enterprise. Uniquely, Amadeus’ compliance intelligence features enable management team members to view all open CAPA processes across the organization and determine status. It provides them with “actionable intelligence” that facilitates timely management decision-making.

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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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