Blood, Biologics & Tissue Quality Management & Manufacturing Solutions
In health-advancing industries, outdated quality and manufacturing processes put progress at risk. Optimize your operations with quality management and manufacturing solutions proven to match the sophistication of your life-saving therapies and services.
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MasterControl Offers 4 Key Advantages
for Blood,
Biologics, and Tissue Companies
Error Prevention
Missing one quality detail or making a single data entry error can keep your products from reaching those who desperately need them. By unifying your manufacturing execution system (MES) and quality management system (QMS) within a single biologics compliance software platform like MasterControl, your organization can eliminate mistakes, work with fully digitized error-proof production records, and prevent quality issues from causing delays.
Streamlined Quality Event Management
Blood, tissue, or biologics quality management failures can emerge during audits and inevitably affect bottom lines. With advanced QMS capabilities, you can prevent costly issues like inspection observations, fees, and delays in getting to products to patients. MasterControl’s Advanced Quality Event Management solution puts the power to design quality processes, capture data, and build forms and workflows entirely in your hands.
Right First Time, Every Time
Meeting good manufacturing practice (GMP) requirements is necessary yet challenging when you’re dealing with in-demand, high-quality products. Using a proven blood, tissue, and biologics manufacturing execution system like MasterControl’s Manufacturing Excellence (Mx) you can optimize production with real-time data capture, rapid identification and resolution of issues, and seamlessly connected data and processes.
Faultless Data Integrity
Incorrect calculations, omitted signatures, and illegible entries are inevitable if your records are maintained manually and your processes are paper-based. With MasterControl solutions, you can avoid the issues that necessitate rework, extend cycle times, and negatively impact product quality and/or delivery times. Plus, MasterControl solutions help you prevent the discrepancies that tend to jeopardize compliance or halt production.
4 Reasons to Adopt Digital Production Records Now
You can have manufacturing operations that consistently achieve your KPIs, routinely deliver products on schedule, and exceed customer expectations. You can align staff and company culture with your corporate mission and get your organization recognized as an industry leader. How can you achieve all this? It starts with the digitization of your production records. Learn the advantages of digitized, rather than paper-based, manufacturing operations. Read this industry brief to understand the common obstacles to digital migration and gain insight into how your organization can overcome them.
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6 Core Capabilities Your QMS Must Have
Building quality into your products requires an effective QMS. Your QMS capabilities are what drive long-term regulatory compliance and market success. However, not every QMS has the same characteristics and connectivity. Quality processes slow down and introduce the possibility of more human error if you’re using an inflexible QMS that doesn’t connect to other functions and is mired in rigid processes. Read this brief to learn the six key capabilities your QMS must have to enable your quality function to increase efficiency, boost brand equity, and keep costs low.
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Solutions for the Blood, Biologics, and Tissue
Quality Management and Manufacturing
From day one, ensuring proper documentation and quality management should be the objective of all blood and tissue organizations and biologics manufacturers. Biologics manufacturing organizations and other similarly oriented companies can start product development on compliant footing with MasterControl Development Excellence, part of MasterControl's fully integrated biologics compliance software platform.
Product quality is the top priority for every company involved in tissue and blood product handling or biologics manufacturing. MasterControl Quality Excellence provides automated document control, change control, training management, audit management, corrective action/preventive action (CAPA) management, and unparalleled process connectivity for life science companies. By automating version control, audit trails, and sign-offs, MasterControl's fully connected solution is the ultimate biologics QMS, streamlining CAPA, eliminating the discrepancies that increase regulatory scrutiny, and optimizing the handling of multiple product lines, which is a huge benefit in biologics contract manufacturing.
Everyone involved in biologics manufacturing and the handling of blood and tissue products bears the responsibility for ensuring quality consistency. MasterControl Supplier Excellence helps companies ensure effective biologics quality management alignment throughout their ecosystems by combining supplier quality management (SQM), approved vendor lists (AVLs), and supplier corrective action requests (SCARs) within a single biologics compliance software platform.
Biologics manufacturers often struggle to connect their quality processes with manufacturing processes, and too many production lines are still reliant on paper. MasterControl Manufacturing Excellence eliminates paper dependency and automates biologics manufacturing execution, a crucial capability for biologics, blood, and tissue operations.
Once a biological product is on the market, its performance must continually be monitored. MasterControl Postmarket Excellence helps blood and tissue organizations and biologics manufacturers track adverse events and resolve issues efficiently. Enhanced tracking monitoring capabilities make it easier for tissue, blood, and biologics contract manufacturing organizations to uphold product quality and maintain regulatory compliance while meeting stringent safety requirements.
Resources for Blood, Biologics, and Tissue Companies
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GxP Lifeline Blog Posts
The Value of Performing a Good Validation In Transfusion Medicine
The blood establishment bears the responsibility for the regulatory compliance of the automated/computerized systems used. Full validation of the computerized system is required for systems critical to product and quality (information management, storage, tools for operational decision-making, and control). The Quality Risk Management approach to validation advocated by GAMP 5 and ICH Q9, a life cycle approach within the QMS, and the use of risk assessments to define the validation strategy for
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CLIA Certification: 3 Things You Need to Know
Testing accuracy and reliability are the top priorities of any laboratory that conducts tests on humans. To demonstrate their commitment to testing integrity, facilities in the U.S. must adhere to Clinical Laboratory Improvement Amendments (CLIA) quality regulations. The path to CLIA certification begins by addressing three fundamental questions.
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5 Critical Factors in the SMART CAPA Process
Just as the name implies, corrective and preventive actions (CAPA) requires action. The key is knowing exactly what kind of action to take to solve the problem and prevent it from happening again.
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FDA 21 CFR Part 606
Companies that handle blood and blood components must comply with 21 CFR Part 606 current good manufacturing practice (CGMP) guidelines. Discover how process automation simplifies compliance with Part 606 and gets blood and related products to patients sooner.
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Case Studies
Getting Products to Patients Faster With Enhanced QMS and EBR Connectivity
Discover how the digital connectivity enabled by a regenerative medicine and biotherapeutic solutions provider’s QMS and electronic batch record solutions has eliminated paper and helped them get products to patients faster. Learn how the company has simplified audits and eliminated data silos and delays due to manual document approvals.
Enabling Innovation With Digital Quality Management
It’s no small feat to deliver innovative, time-sensitive and high-quality results without compromising quality or compliance. Learn how implementing and maintaining a QMS that supports quality and compliance at scale enables a leading provider of clinical biomarker solutions to support effective and reliable quality control and oversight.
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Begin your journey to fully optimized quality management and manufacturing processes in your blood, biologics, or tissue operations.
