Pharma Quality Europe (PQE) offers Consultancy and Services in the field of Computer System Validation (CSV) and Quality Management (QM), in the life sciences.

Role in HealthAgents

Provide the partners involved in the development of the software required for the creation of HealthAgents system with the assistance required for the implementation of the Quality System during software development activities, including all software validation activities and corresponding quality documentation.

Background

PQE has put together one of the largest and most experienced groups of professionals in Computer System Validation and Quality Management and represents the first case of a Contract Quality Organisation (CQO). In this context PQE is capable of handling a wide variety of projects, regardless of size and complexity, in the areas of Manufacturing and Research & Development. Extensive knowledge of Project Management is also a key feature of PQE’s teams. This is closely linked to a solid understanding of International Regulatory Issues, acquired over many years of experience within the pharmaceutical industry.

PQE was founded in 1998 and has experienced rapid growth in terms of internal resources and number of projects/clients. Today, PQE is an organisation of 50 people, operating from five offices in Europe, located in Florence (headquarters), Milan, Rome and Barcelona. In February 2001 a private limited Spanish company, Pharma Quality Europe S.L., was established in Barcelona. 

People

Gilda D’Incerti Degree in Economics at the "Bocconi" University of Milan. G. D’Incerti has worked in the area of Information Technology for national and international companies such as Siemens Data (Milan), Rizzoli-Corriere della Sera (Milan) and Edicon (Montreal). From 1990 to 1995 she held the position of IT Manager for the Spanish affiliate of the Menarini Group, located in Barcelona. Before the foundation of PQE in 1998, she held the position of Operations Manager for F&J Systems Italy, and Motherwell Information Systems. She is an international expert in the field of Computer System Validation due to the validation projects performed and the training activities even executed for regulatory bodies.

Other projects

More than 300 Computer System Validation projects have been performed over the last three years, both in Manufacturing and Research&Development. Namely, Manufacturing: 21 CFR Part 11 compliance, ERP systems (Enterprise Resource Planning), MRP systems (Material & Resource Planning), LIMS (Laboratory Information Management System), MHS (Material Handling System), EBR (Electronic Batch Record), and DCS (Distributed Control System); Process equipment: Dispensing (Weighing System); Utilities: Infrastructure (Networks); Research and Development: 21 CFR Part 11 compliance, LIMS (Pharmacokinetics, Analytical), Laboratory instrumentation (HPLC, LMS), Preclinical Databases (Toxicology, Animal Facilities), Clinical Databases (Multi-centre Trials, Pharmaco-vigilance), and e-CRF (WEB-based and WEB-enabled).