ISPE GAMP R and D and Clinical Systems SIG publish first Concept Paper

New Drug Approvals

ISPE GAMP R&D and Clinical Systems SIG publish first Concept Paper

When changing from paper-based to computerized systems and processes in the field of Good Clinical Practice (GCP), validating these systems is of critical importance, as inspectors are increasingly focussing on this facet of clinical trials. The ISPE GAMP R&D and Clinical Systems SIG has published a Concept Paper on the application of GAMP 5 validation principles to the GCP field.  Read more here about the Concept Paper

http://www.gmp-compliance.org/enews_4287_ISPE%20GAMP%20R%26D%20and%20Clinical%20Systems%20SIG%20publish%20first%20Concept%20Paper_8457,8366,8308,Z-COVM_n.html

ISPE GAMP R&D and Clinical Systems SIG publish first Concept Paper As the pharmaceutical industry increasingly transitions from paper-based to computerized processes, the validation of these systems is also becoming a focus of inspections in the field of clinical trials. This has resulted in an increased need for guidances and guidelines concerning GCP-regulated systems, especially since these systems play a crucial role in the life cycle of medicinal products. Currently, there…

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