Good Manufacturing Practice (GMP) ensures medicinal products are produced consistently and controlled to the quality standards appropriate for their intended us

Data integrity is fundamental in a pharmaceutical and medical devices quality system. This book provides practical information to enable compliance with data in

Validation of computer systems is the process that assures the formal assessment and report of quality and performance measures for all the life-cycle stages of

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Guiding chromatographers working in regulated industries and helping them to validate their chromatography data systems to meet data integrity, business and reg