Effective Process Change Control

Introduction

The old adage that — the only thing constant is change — is true.  Within organizations, changes are always occurring due to market drivers, staff changes, new regulations, resource availability, and technological changes.  These changes can include changes in policies and procedures, processes, systems, staff, products, services, equipment, materials, emissions, etc.  Change management refers to the ability to request, analyze, and decide on a change in a document, process, or object, and then to track the status of that change. Each time a change occurs in the organization, it will impact other areas of the organization and throughout the value chain.

For example, if a new software application is installed within an organization (an audit system), new SOPs will need to be written for the system, training will need to be scheduled, and the auditee may need to be notified that their reports will look different.  For an organization to minimize the risk that changes can have on the organization, the organization must identify these potential changes, thoroughly evaluate the impacts of the changes and the risk of not doing them, obtain the necessary approvals, communicate with the affected parties, and create action plans to implement the changes. Change management is not just a matter of best practices, it is the law for most companies.

Under several regulatory standards and guidelines, change control– or controlling or managing change within an organization– must be conducted to ensure that the organization can maintain and improve quality by identifying changes that could improve the product, ensuring proper review and analysis of the changes, and documenting and communicating the changes to the appropriate stakeholders.  For example, the ISO regulations, having a continual improvement and document control tone, infer that change should be managed.  In addition, the medical device regulations of 21 CFR Part 820, specifically regulate change management. 

Change Control Challenges

There are many problems associated with documentation and change control. The most frequent ones are:

Problems associated with Documentation and Change Control

Most problems can be solved by developing procedures and having those procedures embedded into the change control process.  In addition, a key solution is to ensure the narrower perspective of change control – the formal process ensuring that any changes to elements within the organization are performed in accordance with the change specification—is done within the broader framework of change management.  Change management is that broader process that allows for standardization of procedures and activities for all types of changes, and the monitoring of those changes within a continual improvement mindset to minimize change-related impacts and enhance efficiency.

Best Practices for Good Automated Change Control

A good automated change control system provides these components:

  1. Establish consistent enterprise change control procedures. Change control affects the entire enterprise. It is best practice to establish global internal policies and procedures from the top down for effective change control management of both documents and processes.
  1. Avoid point solutions. Change control is an essential core component of your quality management systems infrastructure. Avoid one-off point solutions to address these requirements. It is recommended best practice to apply consistent change control procedures across the enterprise and standardize on a systems approach that facilitates organizational collaboration and process change.
  1. Security. Prevents or detects unauthorized or accidental changes. This component of the change control system will address the internal control requirement that all changes require authorization prior to implementation.
  1. Documented changes. The current best practice is to ensure that the system maintains a detailed history of all changes and records the time and dates of any changes, who made them, and their ultimate disposition (successful or deleted). This aspect of an automated change control system addresses the internal control requirement that stipulates authorization of changes and requires traceability for actual changes.
  1. Quality assurance. The established current best practice for change control is designed to ensure consistency. Quality assurance procedures for review and approval should be applied to ensure consistency.
  1. 21 CFR Part 11 compliance. Current best practice dictates that all change control systems be designed in compliance with 21 CFR Part 11 requirements.
  1. Comprehensive document/process lifecycle workflow. Documents and processes change throughout business operations. Effective management and change control of processes and documents is essential to efficient business operations. Current best practice thinking for mature organizations is to automate compliance processes and manage their lifecycle while controlling all documents in support of these processes. It is recommended best practice to establish an automated change control workflow process to support both documents and processes.
  1. Ensure validation. It is established best practice that all change control systems be deployed in validated systems environments. Change control is mandated under GMP predicate rules that require validation for all quality processes. It is important to establish a set of user requirements for the system so that all validation activities can be performed following the intended use.
  1. Built-in best change control best practices. An effective change control system includes built-in best practices to support the following regulatory requirements as mandated by cGMP predicate rules.

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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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