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FEATURED ARTICLES

  • Solving the OOS Problem with Continuous Manufacturing
    Solving the OOS Problem with Continuous Manufacturing

    With continuous manufacturing, it is possible to monitor product quality continuously, and make adjustments in real time to keep the product in spec. And when it isn’t, as will sometimes (albeit rarely) happen, the manufacturer can step in more quickly than ever before to limit the volume of OOS product — saving time, money, and staying ever closer to the ideal quality standard.

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WHITE PAPERS & CASE STUDIES

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PRODUCTS & SERVICES

Enterprise Asset Performance Management Software for Life Sciences, Pharma Enterprise Asset Performance Management Software for Life Sciences, Pharma

Technology, enabled by the Industrial Internet of Things (IIoT), is empowering organizations to shift to a holistic and operations-centric view where proactive and predictive maintenance (PdM) enables front line personnel in life sciences to act before costly failures occur.

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)

'A Measure of Success for Quality Control, R&D and Production 'A Measure of Success for Quality Control, R&D and Production

Pharmaceutical companies work throughout their supply chain in a field dominated by regulations and demands for high quality.

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