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

Free Resources

Download these free resources to learn how MasterControl solutions are flexible and robust to meet the needs of the entire business.

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Ensuring Compliance with Federal Regulations

Blood banks, transfusion centers and tissue banks are covered by various regulations. These include the Food and Drug Administration (FDA), the Clinical Laboratory Improvement Amendments (CLIA) and the College of American Pathologists (CAP). Using MasterControl, companies automate quality and compliance processes, meet the regulatory requirements faster and launch products sooner.

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Ensure Compliance With Global Regulations

Blood, biologics and tissue companies are always looking to improve processes to stay current and compliant with global regulations. MasterControl helps companies boost quality, overcome regulatory challenges and reach their business goals.

Elevate Quality, Reduce Risk, Ensure Compliance

Pursue approvals with confidence.

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Quality and getting to market fast are top priorities for life sciences companies. Using MasterControl’s software solutions, companies increase efficiency, achieve compliance and meet or exceed release deadlines.

Avoid Receiving a Form 483

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Form 483s lead to costly setbacks. They also increase the risk of missing critical market-entry timelines. Automate quality processes to satisfy Current Good Manufacturing Practices (CGMP), ensure compliance and deliver products faster.

Streamline Audits

Audit for Compliant solutions

Current Good Tissue Practices (CGTP) ensure the safety of tissue-based products. They also apply to document management, record keeping and audit preparation. MasterControl helps you always remain audit ready. 

Solutions for the Blood, Biologics and Tissue Industry

MasterControl Development Excellence™ Solution

Development

The MasterControl Development Excellence solution automates design history file (DHF) and device master record (DMR) tasks. It facilitates cross-functional collaboration and document control. Documents are easy to track, retrieve, revise, approve and share. Improve efficiency, ensure compliance and accelerate time to market.

MasterControl Clinical Excellence™ Solution

Clinical Excellence

The MasterControl Clinical Excellence solution helps you store, manage and track digital content as part of your electronic trial master file (eTMF). Ensure audit readiness by automating clinical operation and quality management from pre-clinical through phase IV trials.

MasterControl Regulatory Excellence™ Solution

Regulatory

The MasterControl Regulatory Excellence solution simplifies managing documents, dossiers and submissions. It also automates 510(k) management workflows. Align regulatory and quality data and streamline global registrations. 

MasterControl Quality Excellence™ Solution

Quality

The MasterControl Quality Excellence solution is a closed-loop quality system. It automates and streamlines GxP processes. Improve the efficiency of document control, change control, training management, audits, corrective/preventative action (CAPA), customer complaints, and other quality processes throughout the product lifecycle.

MasterControl Supplier Excellence™ Solution

Supplier

The MasterControl Supplier Excellence solution seamlessly connects all supplier quality management processes. Automate and streamline corrective and preventive actions (CAPAs), supplier corrective action requests (SCARs), deviations and approved vendor lists (AVL). Improve the efficiency of audit management — internally and across the supply chain.

MasterControl Manufacturing Excellence™ Solution

Manufacturing

The MasterControl Manufacturing Excellence solution bridges the paper gap between your quality management system (QMS) and manufacturing execution system (MES). It digitizes and automates the labor-intensive last mile of the production record management processes. Experience immediate improvements with operational efficiency and productivity.

MasterControl Postmarket Excellence™ Solution

Postmarket

The MasterControl Postmarket Excellence solution seamlessly unites postmarket surveillance efforts and customer feedback with core quality processes. Automating actionable and intelligent postmarket surveillance drives product improvement. Easily manage risk, close the quality management loop and ensure compliance. 

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