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FEATURED ARTICLES

  • Incorporating Lean Principles Into Pharmaceutical QC Laboratory Design
    Incorporating Lean Principles Into Pharmaceutical QC Laboratory Design

    This article presents a case study based on an international workshop hosted by Novartis Vaccines to prepare guidelines for incorporating lean principles into pharmaceutical quality control laboratory design. By Mike Dockery, Federico Gabardi, Javier Garay, Jim Gazvoda, Luke Kimmel, Pietro Orombelli, Christophe Peytremann, Tom Reynolds, Tanya Scharton-Kersten, Graham Shoel, and Jeanne Sirovatka

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WHITE PAPERS & CASE STUDIES

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PRODUCTS & SERVICES

Adverse Event Reporting, Safety and Compliance Software

Adverse Event Reporting, Safety and Compliance Software

Adverse event (AE) reporting is a key process point for maintaining safety and compliance. Unfortunately, it’s also incredibly labor-intensive. AE source documents arrive in just about any form—mail, fax, email, even voice records from call centers.

Drug Safety Issue Tracking Software

Drug Safety Issue Tracking Software

Monitoring and tracking the efficiency and accuracy of organizations’ drug safety reporting process can help to ensure issues are logged and investigated when they arise, avoiding delays and/or inaccurate reporting which can result in lack of regulatory compliance, monetary fines, and unwanted scrutiny.
Drug Safety Software Adverse Event Reporting

Drug Safety Software Adverse Event Reporting

TrackWise by Sparta Systems’ Adverse Event Reporting solution tracks reported adverse events and manages the processing of all cases from initial triage through reporting and case closure.
Drug Safety Audits Software

Drug Safety Audits Software

Without a means to track and schedule, drug safety audits tend to be performed on an irregular basis, typically resulting in disconnected audits with recommendations that not followed up on.
CAPA Software

CAPA Software

The TrackWise by Sparta Systems Corrective Action and Preventative Action (CAPA) solution for the pharmaceutical and biopharmaceutical industries automates CAPAs precipitated by deviations, complaints, and other quality processes.

Supply Chain Compliance Management

Doxis is Internet-delivered Supply Chain Compliance Management (SCCM)

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