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FEATURED ARTICLES

  • Pharma’s Quest For Consistent Quality
    Pharma’s Quest For Consistent Quality

    The preliminary findings from the International Society of Pharmaceutical Engineering’s (ISPE’s) Quality Metrics Pilot Program were revealed at the association’s recent Quality Metrics Summit. How will this data help the pharma industry create a universally accepted set of manufacturing quality standards and what challenges did the pilot uncover?

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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.

Life Sciences, Pharmaceutical Regulatory Compliance Software And Services Life Sciences, Pharmaceutical Regulatory Compliance Software And Services

The Schneider Electric team of dedicated industry experts is focused on providing companies with strict regulatory adherence in a timely and cost-effective manner. This includes comprehensive regulatory compliance and validation services, focused on but not limited to, environmental monitoring systems, building management systems, manufacturing, processing and packaging equipment and automated business systems (MES, laboratory, Information Technology). The Schneider Electric offerings for life sciences also include quality audits and assessments. Our full range of services and solutions are vendor and platform independent, providing organizations , such as pharmaceutical and biopharma manufacturers with an objective and authoritative view.

Pharmaceutical Cyber Security Services Pharmaceutical Cyber Security Services

Schneider Electric addresses an organization's compliance and cyber security challenges from analysis through to implementation and management. We start by providing expert consulting with a track record of global success to assess the current compliance situation. We then define an overall Cyber Security plan and remediation strategy encompassing processes, procedures, people, products, networks and applications.

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.
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