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Quality

Blood, Biologics and Clinical Labs

Top blood, biologic and clinical labs rely on MasterControl for connecting quality document and data processes to drive efficiency and actionable insights to help improve quality and ensure compliance.

The MasterControl product lifecycle excellence platform is designed to automate quality processes and provide blood, biologic and clinical labs a single source of truth for product quality data across the enterprise and the wider ecosystem.

Software Automation in the Blood and Biologics Industry

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Ensuring Compliance with Federal Regulations

Blood banks, transfusion centers, and tissue banks are covered by a number of regulations, including the Food and Drug Administration's (FDA) 21 CFR Parts 600, 606, 21 CFR Parts 210-211, 21 CFR Parts 1270-1271, 21 CFR Part 11 (for those maintaining electronic record-keeping systems), and the Clinical Laboratory Improvement Amendments (CLIA). In addition, many blood establishments affiliated with hospitals adhere to quality standards by the College of American Pathologists (CAP), a professional organization that provides voluntary accreditation.

The MasterControl Product Lifecycle Excellence solutions help blood, biologic and clinical labs leverage compliance requirements by automating and accelerating quality and compliance processes across the enterprise - all on the MasterControl Platform™.

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Ensuring Compliance with Global Regulations

Maintaining quality and continually improving process efficiencies is an increasingly difficult endeavor in the blood and biologics community especially as regulatory requirements increase. To meet these challenges, organizations must look for ways to improve process efficiencies to remain viable, while staying compliant with world-wide regulatory bodies. MasterControl provides a sure foundation for compliance and quality management.

Blood, Bio and Tissue Organizations who Rely on MasterControl

MasterControl Offers Three Key Advantages

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Mobile Access

MasterControl allows users to access information and perform tasks using a tablet or a smartphone. Mobile access offers greater flexibility for users and helps boost overall efficiency and productivity.

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Cloud Solutions

Leveraging cloud technologies is critical for automating quality processes. Companies without access to its speed and adaptability will struggle to maintain a competitive edge. MasterControl isn't just a cloud-based solution. Its dedicated teams and specialized tools help make your implementation simple and your experience seamless.

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Flexible and Effective Framework

MasterControl provides an effective framework for a company's quality management system (QMS) by automating all documents- and forms-based processes, connecting all quality processes, and providing a centralized location for all documents and data.

Solutions for the Blood, Biologics and Clinical Lab Industry

01

MasterControl Development Excellence™ Solution

Development

MasterControl Development Excellence™ ensures that quality is embedded into drug development from day one and ensures the right documentation and data flows with your product throughout its entire lifecycle.

02

MasterControl Clinical Excellence™ Solution

Clinical Excellence

MasterControl Clinical Excellence helps you connect, manage, track, organize and store essential digital content as part of their electronic trial master file (eTMF) along with automating clinical operation and quality management from pre-clinical through phase IV trials.

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MasterControl Regulatory Excellence™ Solution

Regulatory

MasterControl Regulatory Excellence integrates content and quality management to help with eCTD submissions and the organization and harmonization of regulatory and quality processes to accelerate submissions.

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MasterControl Quality Excellence™ Solution

Quality

MasterControl Quality Excellence is a closed-loop, single source quality system that allows you to embed quality into every process across the drug development lifecycle — from concept to commercialization and back again.

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MasterControl Supplier Excellence™ Solution

Supplier

MasterControl Supplier Excellence seamlessly connects all supplier quality management processes, including corrective and preventive actions (CAPAs), supplier corrective action requests (SCARs), deviations, and audit management, internally and across the supply chain.

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MasterControl Manufacturing Excellence™ Solution

Manufacturing

MasterControl Manufacturing Excellence helps bridge the paper gap between your quality management systems (QMS) and manufacturing execution systems (MES) by digitizing and automating the labor-intensive last mile of the production record management process to drive immediate improvement and operational efficiency.

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MasterControl Postmarket Excellence™ Solution

Postmarket

MasterControl Postmarket Excellence seamlessly unites postmarket surveillance activities and customer feedback with core quality processes to enable you to effectively manage risk and ensure compliance.