FEATURED ARTICLES
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![Viral Safety Approaches For Advanced Therapy Medicinal Products]( "Viral Safety Approaches For Advanced Therapy Medicinal Products")
Viral Safety Approaches For Advanced Therapy Medicinal ProductsManufacturers safeguard biologic materials during the development process through a set of measures commonly referred to as the “Safety Tripod.”
WHITE PAPERS & CASE STUDIES
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![Inspecting On The Edge – Understanding Punch Tip Wear In Pharmaceutical Manufacturing]( "Inspecting On The Edge – Understanding Punch Tip Wear")
Inspecting On The Edge – Understanding Punch Tip WearAvoid production quality-related issues by understanding and knowing how to identify the most common causes of punch tip edge wear.
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![Improving Compliance And Manufacturing Efficiency In Life Sciences]( "Improving Compliance And Manufacturing Efficiency In Life Sciences")
Improving Compliance And Manufacturing Efficiency In Life SciencesCurrent market conditions such as regulations and mergers or acquisitions make improving compliance and manufacturing efficiency while driving to grow revenue and margins difficult.
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![Medical Device Manufacturer Improves Product Quality Control]( "Medical Device Manufacturer Improves Product Quality Control")
Medical Device Manufacturer Improves Product Quality ControlOsstem Implant adopted an integrated business framework that helps it eliminate traditionally disconnected processes and data and increase the efficiency and accuracy of its product quality control.
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![TMFSystem]( "Points To Consider When Developing A TMF (Trial Master File) Strategy")
Points To Consider When Developing A TMF (Trial Master File) StrategyMany organizations are currently outsourcing clinical trial activities to one or more contract research organizations (CROs). By Karen Redding, Global Business Development Director, Phlexglobal Ltd.
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![Micomiforms]( "Improve Accuracy And Efficiency In Data Collection For Mental-Health Evaluations And Assessments")
Improve Accuracy And Efficiency In Data Collection For Mental-Health Evaluations And AssessmentsMedAvante is a global provider of centralized, expert psychological rating services to the pharmaceutical, biotechnology, and medical device industries.
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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?”
PRODUCTS & SERVICES
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.
Metrics Contract Services offers a complete elemental impurities program designed to comply with the USP 232 and USP 233 Elemental Impurities proposed chapters which become official on December 1, 2015.
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.
