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 Pharma Quality Europe (PQE) offers Consultancy
and Services in the field of Computer System Validation, Quality Management,
Quality Engineering and Technical Qualification primarily for pharmaceutical,
chemical-pharmaceutical, medical device and biomedical companies.
Due to the broad
spectrum of services offered and to the number of senior consultants operating
within the company, PQE represents the first example of a Contract Quality
Organization (CQO). In this context PQE is capable of managing a wide variety
of Computer System Validation and Quality Management Projects, regardless of
size and complexity, in the areas of Manufacturing and Research &
Development. PQE is able to synergistically combine four different disciplines:
Quality, Information Technology, Engineering and Pharmaceuticals. 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.
Pharma Quality Europe
(PQE) was founded in 1998 combining the expertise acquired by its founding
partners in the fields of Computer System Validation (CSV) and Quality
Management (QM). A group of professionals with extensive experience in the
management of CSV and QM projects joined the company from the very beginning.
Some of them were already active as consultants and some others had worked in
the Quality and IT areas within the pharmaceutical industry.
The company has experienced rapid growth in terms of internal
resources and the number of projects and clients. On February 2001 a Spanish
affiliate, Pharma Quality Europe S.L., was founded in Barcelona and on November
2005 we opened a branch office in South America (Ecuador). In the 1st quarter
of 2006 we are planning further expansion in Europe (France).
Today PQE is an organization of around 100 professionals, operating from four
offices in Europe, located in Figline Valdarno (Florenc
e), Milan, Rome and Barcelona. On March 27th 2003 Pharma Quality Europe was
granted the UNI EN ISO 9001:2000 Certificate, released by Det Norske Veritas
Italia S.r.l. On March 2006 PQE Quality System was fully reassessed by Det
Norkse Veritas and ISO Certification was renewed for the next three years. Currently the pqe quality system is under inspection by CERTIQUALITY S.r.l. for obtaining the renewal of the certificate.
PQE’s Quality System was implemented and certified for all
operational offices in Italy, located in Milan, Figline Valdarno and Rome,
regarding "Design and provision of services for: Computer System Validation,
Technical Qualification of equipment and engineering consultancy in Life
Science field, conduct of audits and preparation of Quality System documents
for Life Science field. Services of coordination, support and monitoring of clinical trails both in publics and privates sites, including ethical and administrative activations, data management, statistical analysis and reporting." |
