We provide support for all steps in the product lifecycle and IT compliance.
Data integrity (DI) is an extremely important factor for companies in the life sciences sector, such as pharmaceuticals and medical devices, in both regulatory and business contexts. PQE supports the achievement of your compliance with an integrated data governance system that ensures the quality system functions effectively. To conduct DI related to regulations, computer system validation is crucial, and as a global leader in this field, we provide excellent support to our clients from both cost and practical perspectives.
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basic information
■Data Integrity Policy ■Data Integrity Historical Verification ■ALCOA Assessment ■Data Integrity Improvement Plan ■Continuous Monitoring Methods for Data Integrity ■Audit Trail Review Methods
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Company information
PQE Group was established in Italy in 1998 and celebrated its 25th anniversary last year. It is a consulting company certified with ISO9001, providing a variety of consulting services in the life sciences industry for pharmaceutical companies, medical device companies, and manufacturers. As part of GXP system support, it offers services such as CSV, digital governance, and DX compliance, as well as data integrity assessments and accompanying improvement support. Additionally, it provides inspection response solutions for FDA, EMA, and others, and has extensive knowledge of the latest regulatory information from various countries, enabling support for overseas approval applications, eCTD creation and management, matching with overseas manufacturers of target active pharmaceutical ingredients, master file creation and management, gap analysis and strategy development support, and pre-approval market research, along with CQV services such as equipment and instrument qualification assessments. For third-party audits of GMP, GDP, GCP, and GVP, it is capable of conducting audits on a global scale. With a wide portfolio, extensive experience in each service, effective project management, and excellent cost-effectiveness, it has a strong track record of supporting a range of clients from global corporations to Japanese companies and venture firms.