Contracting Organizations and the need for written

Transfer Obligations and Quality Agreements

Outsourcing of pharmaceutical, biotechnology, and medical device clinical research and manufacturing has grown significantly in the past several years, and the trend is predicted to continue.  There are several explanations for why this growth in outsourcing has occurred. The growth in clinical research, limited corporate infrastructure or in-house expertise to create new products explains some of the expansion; the mitigating of financial and compliance risk may explain the remainder.  Many companies use outsourcing, in addition to internal resources, because having alternate capabilities included in the regulatory submissions provides protection in the event of supply interruptions, manufacturing problems at a given site, or unexpected increases in demand.

In this paper, Kevin Bogert provides guidance on what Transfer Obligations and Quality Agreements should contain. 

Kevin Bogert is currently Managing Member of Azimuth Compliance Consulting. He has more than 35 years of business experience, 30 of them in the life science industry, where he has been involved in global implementations of training, quality, and regulatory systems. His background includes statistics, quality and regulatory systems, computer and process validation, and automation of manufacturing processes.

He can be contacted at: kbogert@azimuthcc.com

10 Biggest Mistakes in Process Modeling

Process modeling is a technique that allows an organization’s knowledge to be seen as flowcharts. It simplifies understanding of tasks, deadlines, and responsibilities, while also identifying opportunities for improvement.

For process modeling to show results, some aspects need to be considered. Many companies fail on this point, facing various difficulties and achieving limited results.

In this article, Alexandre Mello presents 10 of the biggest mistakes made in modeling and process documentation initiatives. Recommendations are also provided on how to avoid these pitfalls, so that processes can indeed deliver value and effectiveness for an organization.

Author: Alexandre M. V. Mello has owned and managed consulting education businesses (Expertise and BPM Experts) for more than 2 decades. His expertise includes facilitation, strategy development, process architecture definition, process CoE organization, and process analysis and improvement. Besides consulting engagements, he delivers training programs, workshops and conferences. He can be contacted at: alexandre@bpmexperts.com.br

Why Your Document Control System is Obsolete

For many years companies have implemented document control systems that had the ability to manage the version of the document throughout their life cycle. As documents were approved the process would notify users that a new version is available and obsolete copies should be discarded. That changed with the newer version of ISO and the issuance of the FDA’s data integrity guidance document.

In this paper, Kevin Bogert examines why most document control systems on the market do not meet the requirements of a document control system. He provides insight into what is required of a document control system. His other paper, "Data Integrity: a Document Control Challenge", he examines what is missing from document control systems based on FDA's guidance document related to data integrity.

Kevin Bogert is currently Managing Member of Azimuth Compliance Consulting. He has more than 35 years of business experience, 30 of them in the life science industry, where he has been involved in global implementations of training, quality, and regulatory systems. His background includes statistics, quality and regulatory systems, computer and process validation, and automation of manufacturing processes.

He can be contacted at: kbogert@azimuthcc.com

Digital Transformation Map

Digital transformation impacts every organization. Today, companies that have already embraced digital transformation are generating better profit margins and more net revenue than companies that are late to adhere to this new business model.

Many of organizations which find themselves behind the curve are struggling to find agreement on the scope of their digital transformation. Defining this scope is critical to understanding the expected impact on business. As digital transformation can be a difficult subject to understand, it is necessary to define a simple and practical model that will help all teams discuss this topic.

Since digital transformation is a difficult topic to understand, we need a simple, practical model that helps all parties discuss the subject. In this white paper Tero Lindholm introduces a Digital Transformation Map to facilitate collaboration around this major change. Its key purpose is to provide you with a framework to help identify the crucial building blocks that are most often impacted during the digital transformation process.

Author: Tero Lindholm is VP on Midagon, a Finnish ICT company focused on project management and digital transformations. He has vast experience in program/project management on Information and Communications Technology (ICT) industry, as well as superb digital customer innovation & changes results in international business environments. Lindholm have special skills for cross cultural relationships and people leadership from planning to operational support and improvements.

Data Integrity: A Document Control Challenge

What should I consider when implementing a competency-based training system

Government regulations, directives, and guidelines are gradually catching up to ISO standards in the requirement of competency-based training.

To establish and maintain a competency-based training program, the following steps must be taken: