Bio

Dr. Roland Doclo’s prime interests are the application of Good Practices and the effective use of Information Technology to support mission critical business processes, in particular for companies involved in manufacturing, pharmaceutical and clinical research organisations. Dr. Doclo has been actively involved in the implementation of automated systems, based on a quality systems approach and using a pragmatic and effective methodology. The foundation of the methodology consists of a common-sense interpretation of regulatory requirements and is based on de-facto industry standards, such as IEEE and ISO. This methodology has been applied successfully in the areas of GMP (Good Manufacturing Practices), GLP (Good Laboratory Practices) and GCP (Good Clinical Practices). Since 1969, Dr. Doclo has been implementing and managing automation projects using conventional automation technologies and advanced computerised control systems. He has practical experience in the process manufacturing as well as the discrete manufacturing industry. His areas of competence are: business process redesign, factory and laboratory automation, process control, materials handling and inventory control, capacity planning and scheduling, maintenance management, activity based costing, project management, etc. In addition, he has managed Information Systems departments (including systems development and data centre operations) and he has been actively involved in the application of advanced software engineering techniques and the management of major projects. Dr. Doclo holds a Master Degree in physics (University of Gent, Belgium, 1963) and a Ph.D. in Physics (University of Gent, Belgium, 1968). As a Fellow of the Belgian-American Educational Foundation (1966-1968), he has studied and performed basic research work at the Massachusetts Institute of Technology, Cambridge, USA. Dr. Doclo started his career as a research scientist at the University of Gent and at the Massachusetts Institute of Technology. From 1969 he developed his industrial career, first implementing automation engineering solutions and managing the IT department with Bayer (until 1979), then with Cockerill Yards Hoboken NV (until 1982). From 1982 until 1985, he managed his privately owned company (CIMS NV) providing IT services and development of IT management solutions. He has been employed since 1985 by Digital Equipment Corporation in a senior professional and management position. In this capacity, Dr. Doclo has developed and implemented methodologies for Key Performance Indicators, Risk Management, Competency Management, Validation of Computerised Systems, etc. Dr. Doclo has been active as an independent Consultant since 1995, performing consulting engagements for pharmaceutical, clinical research and other organizations serving the pharmaceutical industry, such as reference laboratories and IT system suppliers throughout Europe and USA. Typical engagements are the audit and the development of company-wide programs for validation. Systems included data management applications, adverse events applications, laboratory information systems, etc. Other assignments included the development of Validation Master Plans, the introduction of Quality Systems (including policies and procedures), the development of standards for the validation of data centres and computing infrastructure, the validation of analytical methods and analytical equipment, the assessment of suppliers, training (validation methodology, GLP principles, GMP principles), etc. From 1996 until 1999, Dr. Doclo has been serving as the Membership Officer and Treasurer of the European Forum for Good Clinical Practices (EFGCP) which is a not-for-profit international organisation devoted to the promotion of Good Clinical Practices. From 2001 on (since his retirement as a professional consultant), Dr Doclo has served numerous organisations either as a member of the board or as a volunteer mostly for not-for-profit organisations. His ambitions are to enhance their organisational competencies by streamlining internal procedure with a focus to efficiency and quality. Dr Doclo has implemented practical methods for efficient management and administration of daily operations that apply to a variety of organisations. Dr Doclo has implemented methods for effective management and deployment of cultural heritage collections. Contact Information : Dr. Roland Doclo Warandestraat 5 Bus 7 B-2300 Turnhout - Belgium Tel : +32-(0)14-715 611 email : rdoclo@gxpconsulting.com

Expertise

Procesautomatisering, ICT-ontwikkeling, change management, kwaliteitsbeheer