This is a collaborative whitepaper which offers insights and guidance on transforming Quality Assurance (QA) in Good Clinical Practice (GCP) and Good Pharmacovigilance Practice (GVP) through the application of advanced analytics.

This Framework reflects on the learnings and key decisions taken by the Intercompany Quality Analytics (IMPALA) Consortium to elevate the goal of advancing analytics in GCP and GVP. This framework can guide Quality Assurance in development, implementation and enhancement of their analytics and technology strategy, regardless of organizational maturity.

Goal

Share the benefits, key learnings and considerations when establishing advanced analytics capabilities in pharmaceutical quality organisations regardless of their maturity in this area.

Expected Outcomes

White paper outlining the considerations for establishing advanced analytics capabilities in pharmaceutical quality organisations.

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Data Analytics for Quality Assurance in Pharmaceutical Development Framework

The “Data Analytics for Quality Assurance in Pharmaceutical Development Framework” is a collaborative whitepaper which offers insights and guidance on transforming Quality Assurance (QA) in Good Clinical Practice (GCP) and Good Pharmacovigilance Practice (GVP) through the application of advanced analytics.

This Framework reflects on the learnings and key decisions taken by the Intercompany Quality Analytics (IMPALA) Consortium to elevate the goal of advancing analytics in GCP and GVP. This framework can guide Quality Assurance in development, implementation and enhancement of their analytics and technology strategy, regardless of organizational maturity.

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