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FEATURED ARTICLES

• 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.

• Viral Safety Approaches For Advanced Therapy Medicinal Products
• Insight Driven Formulations Development
• Managing GxP Environmental Systems To Ensure Data Integrity
• Pharma’s Quest For Consistent Quality

WHITE PAPERS & CASE STUDIES

• Improving Compliance And Manufacturing Efficiency In Life Sciences

  Current market conditions such as regulations and mergers or acquisitions make improving compliance and manufacturing efficiency while driving to grow revenue and margins difficult. Read on to understand strategies, frameworks and recommendations to achieve these goals.

• Medical Device Manufacturer Improves Product Quality Control

  A platform’s integrated business framework helps dental implant and medical device manufacturer eliminate traditionally disconnected processes and data and increase the efficiency and accuracy of its product quality control.

• Points To Consider When Developing A TMF (Trial Master File) Strategy

  Many organizations are currently outsourcing clinical trial activities to one or more contract research organizations (CROs). By Karen Redding, Global Business Development Director, Phlexglobal Ltd.

• Improve Accuracy And Efficiency In Data Collection For Mental-Health Evaluations And Assessments

  MedAvante is a global provider of centralized, expert psychological rating services to the pharmaceutical, biotechnology, and medical device industries.

• Selecting, Implementing, And Using FDA Compliance Software Solutions

  We begin by asking the question, “Is the Quality Management Software market evolving to be easier, or more complex?”

• Sustainable New Product Innovation With PLM Software

  Siemens PLM Software’s product lifecycle management (PLM) platform helps transform the process of innovation that enables you to turn more ideas into successful and sustainable products. By Siemens Industry, Inc.

PRODUCTS & SERVICES

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 (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

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

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

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

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

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